title: Darbepoetin‐alfa and intravenous iron administration after autologous hematopoietic stem cell transplantation: A prospective multicenter randomized trial Intravenous iron sucrose versus oral iron ferrous sulfate for antenatal and postpartum iron deficiency anemia: a randomized trial Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Intravenous Iron Sucrose in Peritoneal Dialysis Patients with Renal Anemia Ferric carboxymaltose in patients with heart failure and iron deficiency. Intravenous Versus Oral Iron for Treatment of Anemia in Pregnancy: A Randomized Trial Intravenous iron supplementation may protect against acute mountain sickness: a randomized, double-blinded, placebo-controlled trial. Comparative study--efficacy, safety and compliance of intravenous iron sucrose and intramuscular iron sorbitol in iron deficiency anemia of pregnancy. The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Safety and Usefulness of Intravenous Iron Sucrose in the Management of Preoperative Anemia in Patients with Menorrhagia: A Phase IV, Open-Label, Prospective, Randomized Study Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients Intravenous iron exacerbates oxidative DNA damage in peripheral blood lymphocytes in chronic hemodialysis patients. Intravenous iron for the treatment of fatigue in nonanemic, premenopausal women with low serum ferritin concentration. Oral or intravenous iron as an adjuvant to autologous blood donation in elective surgery: a randomized, controlled study. Phase III, randomized study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia. Iron Deficiency Generates Secondary Thrombocytosis and Platelet Activation in IBD: the Randomized, Controlled ThromboVIT Trial Intravenous Iron Sucrose versus Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease—A Randomized, Controlled, Open-Label, Multicenter Study A Randomized, Open-Label, Non-Inferiority Study of Intravenous Iron Isomaltoside 1,000 (Monofer) Compared With Oral Iron for Treatment of Anemia in IBD (PROCEED) High incidence of iron depletion and restless leg syndrome (RLS) in regular blood donors: intravenous iron sucrose substitution more effective than oral iron. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Intravenous iron administration does not significantly increase the risk of bacteremia in chronic hemodialysis patients. A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron Effect of iron-supplemented total parenteral nutrition in patients with iron deficiency anemia. Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia The therapeutic equivalence of oral and intravenous iron in renal dialysis patients. A Randomized Controlled Trial of Intravenous or Oral Iron for Posttransplant Anemia in Kidney Transplantation Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. Blood transfusion reduction with intravenous iron in gynecologic cancer patients receiving chemotherapy. Oral ferrous fumarate or intravenous iron sucrose for patients with inflammatory bowel disease Maintenance of elevated versus physiological iron indices in non-anaemic patients with chronic kidney disease: a randomized controlled trial. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Ferumoxytol for treating iron deficiency anemia in CKD. Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran. A Novel Intravenous Iron Formulation for Treatment of Anemia in Inflammatory Bowel Disease: The Ferric Carboxymaltose (FERINJECT®) Randomized Controlled Trial Efficacy of IV iron compared to oral iron for increment of haemoglobin level in anemic chronic kidney disease patients on erythropoietin therapy. Intravenous versus oral iron therapy for postpartum anaemia. Iron Sucrose Versus Oral Iron Therapy in Pregnancy Anemia Intravenous iron increases labile serum iron but does not impair forearm blood flow reactivity in dialysis patients. Iron therapy in iron deficiency anemia in pregnancy: intravenous route versus oral route. Safety of ferumoxytol in patients with anemia and CKD. Iron prophylaxis in pregnancy: intravenous route versus oral route. Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. Role of oral versus IV iron supplementation in the erythropoietic response to rHuEPO: a randomized, placebo-controlled trial. Comparison of efficacy and safety of two parenteral iron preparations in pregnant women Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Postpartum Anemia: A Randomized Controlled Trial [Iron supplementation during erythropoietin therapy in patients on hemodialysis]. [Intravenous iron sucrose in maintenance dialysis patients with renal anemia: a clinical study]. Intravenous iron and recombinant erythropoietin for the treatment of postoperative anemia A Randomized Controlled Trial of Oral versus Intravenous Iron in Chronic Kidney Disease Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: a multi-centred, placebo-controlled preliminary clinical trial. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Comparison of oral versus intravenous iron therapy in predialysis patients of chronic renal failure receiving recombinant human erythropoietin. Role of perioperative intravenous iron therapy in elderly hip fracture patients: a single-center randomized controlled trial. IRON-HF study: a randomized trial to assess the effects of iron in heart failure patients with anemia. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy. A randomized study of oral vs intravenous iron supplementation in patients with progressive renal insufficiency treated with erythropoietin. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. A randomized, double-blind, placebo controlled, multi-center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome. A comparison between intravenous iron polymaltose complex (Ferrum Hausmann®) and oral ferrous fumarate in the treatment of iron deficiency anaemia in pregnancy Effect of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. Intravenous Iron Sucrose in Chinese Hemodialysis Patients with Renal Anemia Comparison of Intravenous Iron Sucrose to Oral Iron in the Treatment of Anemic Patients with Chronic Kidney Disease Not on Dialysis A 12‐week randomised study comparing intravenous iron sucrose versus oral ferrous sulphate for treatment of postpartum anemia EPIBACDIAL: a multicenter prospective study of risk factors for bacteremia in chronic hemodialysis patients. Intravenous iron sucrose is superior to oral iron sulphate for correcting anaemia and restoring iron stores in IBD patients: A randomized, controlled, evaluator-blind, multicentre study Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. Intravenous administration of iron sucrose for treating anemia in postpartum women. [Effectiveness of oral versus parenteral iron substitution in autologous blood donors]. Postoperative intravenous iron used alone or in combination with low-dose erythropoietin is not effective for correction of anemia after cardiac surgery. Iron dextran in the treatment of iron-deficiency anaemia of pregnancy. Haematological response and incidence of side-effects. A double-blind, placebo-controlled trial of intravenous iron dextran therapy in patients with ESRD and restless legs syndrome. Clinical update: intravenous iron for anaemia A randomized controlled study of iron supplementation in patients treated with erythropoietin. Prevention of blood transfusion with intravenous iron in gynecologic cancer patients receiving platinum-based chemotherapy. Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study. Total infusion of low molecular weight iron-dextran for treating postpartum anemia. Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia Intravenous iron sucrose versus oral iron in treatment of iron deficiency anemia in pregnancy: a randomized clinical trial. Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer-blinded trial. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha.
abstract: We conducted a r and omized study analyzing the impact of darbepoetin alfa ( DA ) administration with or without intravenous ( i.v . ) iron on erythroid recovery after autologous hematopoietic cell transplantation ( HCT ) . Patients were r and omized between no DA ( Arm 1 ) , DA 300 μg every 2 weeks starting on Day 28 after HCT ( Arm 2 ) , or DA plus i.v . iron 200 mg on Days 28 , 42 , and 56 ( Arm 3 ) . The proportion achieving complete hemoglobin ( Hb ) response within 18 weeks ( primary end point ) was 21 % in Arm 1 ( n = 24 ) , 79 % in Arm 2 ( n = 25 ) , and 100 % in Arm 3 ( n = 23 ; P < 0.0001 ) . Erythropoietic response was shown to be significantly higher in Arm 3 ( n = 46 ) than in Arm 2 ( n = 50 ; P = 0.008 ) , result ing in lower DA use , reduced drug costs , and improved quality of life scores , but the effect on transfusions was not significant . In multivariate analysis , DA administration ( P < 0.0001 ) , i.v . iron administration ( P = 0.0010 ) , high baseline Hb ( P < 0.0001 ) , and low baseline creatinine ( P = 0.0458 ) were independently associated with faster achievement of complete Hb response . In conclusion , DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post‐transplant . I.v . iron sucrose further improves erythroid recovery . Am . J. Hematol . 88:990–996 , 2013 . © 2013 Wiley Periodicals , Abstract Objective : To compare oral iron to intravenous iron administration to women in late pregnancy and /or after labor to correct iron deficiency . Methods : 271 anemic women ( 148 pregnant women and 123 women post lower segment caesarean section ) with hemoglobin ( Hb ) levels below 110 g/L were enrolled over a two-year period and r and omized to receive either two tablets FGF ( ferrous sulfate with folic acid ) or 400 mg of intravenous iron sucrose plus folic acid 600 µg . Treatment effectiveness was assessed by measuring Hb and ferritin postpartum on day 1 , day 14 and day 42 . Transfusions of red blood cells and adverse drug reactions were recorded . Results : Data of 214 women were available for analysis . Both forms of iron replacement therapy led to increased hemoglobin and ferritin levels over the testing period . Ferritin was significantly higher in the i.v . iron treatment group compared to the oral iron treatment group ( p = 0.004 ) two weeks after delivery , while Hb values did not differ between the groups . No serious adverse drug reactions were observed . Red blood cell transfusion rate was low ( 1.9 % ) , with equal rates observed in both treatment groups . Conclusion : Intravenous and oral irons were both effective in correcting peripartum anemia , although intravenous iron restored stores faster than oral iron PURPOSE To evaluate the safety and efficacy of intravenous ( IV ) sodium ferric gluconate complex ( FG ) , oral ferrous sulfate , or no iron to increase hemoglobin ( Hb ) in anemic cancer patients receiving chemotherapy and epoetin alfa .  PATIENTS AND METHODS In this open-label , multicenter trial , 187 patients with chemotherapy-related anemia ( Hb < 11 g/dl ; serum ferritin > or = 100 ng/ml or transferrin saturation > or = 15 % ) scheduled to receive chemotherapy and epoetin alfa ( 40,000 U subcutaneously weekly ) were r and omized to 8 weeks of 125 mg of IV FG weekly , 325 mg of oral ferrous sulfate three times daily , or no iron . The primary outcome was a change in Hb from baseline to endpoint , first whole-blood or red blood cell transfusion , or study withdrawal . RESULTS One hundred twenty-nine patients were evaluable for efficacy ( FG , n = 41 ; oral iron , n = 44 ; no iron , n = 44 ) . Mean increase in Hb was 2.4 g/dl ( 95 % confidence interval [ CI ] , 2.1 - 2.7 ) for FG ( p = .0092 vs. oral iron ; p = .0044 vs. no iron ) , 1.6 g/dl ( 95 % CI , 1.1 - 2.1 ) for oral iron ( p = .7695 vs. no iron ) , and 1.5 g/dl ( 95 % CI , 1.1 - 1.9 ) for no iron . Hb response ( increase > or = 2 g/dl ) was 73 % for FG ( p = .0099 vs. oral iron ; p = .0029 vs. no iron ) , 46 % for oral iron ( p = .6687 vs. no iron ) , and 41 % for no iron . FG was well tolerated . CONCLUSION For cancer patients with chemotherapy-related anemia receiving epoetin alfa , FG produces a significantly greater increase in Hb and Hb response compared with oral iron or no iron , supporting more aggressive treatment with IV iron supplementation for these patients Objective To explore the safety and efficacy of intravenous ( IV ) iron sucrose in maintenance peritoneal dialysis ( PD ) . Design R and omized , controlled , parallel-group single-center trial . Setting Blood Purification Center of Chaoyang , Beijing Capital University of Medical Science , China . Methods 46 patients on PD were involved in this trial . 26 patients received IV iron sucrose ( 200 mg iron ) once per week for 4 weeks then once every other week for a further 4 weeks . The other 20 patients received oral ferrous succinate , 200 mg three times per day , for 8 weeks . Hemoglobin , hematocrit , serum ferritin ( SF ) level , and transferrin saturation ( TSAT ) were assessed at baseline and then again after 2 , 4 , and 8 weeks of treatment . Results There were no differences between the IV and oral groups in terms of sex , age , duration of PD , mean dialysate dosage per day , erythropoietin dosage per week , or hematological parameters at baseline . After 4 and 8 weeks of treatment , mean Hb and Hct were significantly increased in the IV group and were also significantly higher than those in the oral group . Levels of SF and TSAT were also significantly increased in the IV group , and significantly higher than in the oral group . After 8 weeks , the response rate in the IV group was 94.8 % , which was significantly higher than that in the oral group . The mean erythropoietin dose was significantly lower in the IV group than in the oral group . Hb , Hct , SF , and TSAT levels were maintained between 4 and 8 weeks in the IV group despite the decrease in dose frequency . There were no adverse events with IV iron . Eight patients in the oral group had adverse gastrointestinal effects . Conclusion IV iron sucrose is safe in PD patients . It increases Hb levels and serum iron parameters more effectively than oral iron ; it is well tolerated and can permit reductions in the required dose of erythropoietin BACKGROUND Iron deficiency may impair aerobic performance . This study aim ed to determine whether treatment with intravenous iron ( ferric carboxymaltose ) would improve symptoms in patients who had heart failure , reduced left ventricular ejection fraction , and iron deficiency , either with or without anemia . METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association ( NYHA ) functional class II or III , a left ventricular ejection fraction of 40 % or less ( for patients with NYHA class II ) or 45 % or less ( for NYHA class III ) , iron deficiency ( ferritin level < 100 microg per liter or between 100 and 299 microg per liter , if the transferrin saturation was < 20 % ) , and a hemoglobin level of 95 to 135 g per liter . Patients were r and omly assigned , in a 2:1 ratio , to receive 200 mg of intravenous iron ( ferric carboxymaltose ) or saline ( placebo ) . The primary end points were the self-reported Patient Global Assessment and NYHA functional class , both at week 24 . Secondary end points included the distance walked in 6 minutes and the health-related quality of life . RESULTS Among the patients receiving ferric carboxymaltose , 50 % reported being much or moderately improved , as compared with 28 % of patients receiving placebo , according to the Patient Global Assessment ( odds ratio for improvement , 2.51 ; 95 % confidence interval [ CI ] , 1.75 to 3.61 ) . Among the patients assigned to ferric carboxymaltose , 47 % had an NYHA functional class I or II at week 24 , as compared with 30 % of patients assigned to placebo ( odds ratio for improvement by one class , 2.40 ; 95 % CI , 1.55 to 3.71 ) . Results were similar in patients with anemia and those without anemia . Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality -of-life assessment s. The rates of death , adverse events , and serious adverse events were similar in the two study groups . CONCLUSIONS Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency , with or without anemia , improves symptoms , functional capacity , and quality of life ; the side-effect profile is acceptable . ( Clinical Trials.gov number , NCT00520780 ) OBJECTIVE : The aim of this study was to compare the efficacy of intravenous iron to oral iron in the treatment of anemia in pregnancy . METHODS : In this r and omized open-label study , 90 women with hemoglobin levels between 8 and 10.5 g/dL and ferritin values less than 13 & mgr;g/L received either oral iron polymaltose complex ( 300 mg elemental iron per day ) or intravenous iron sucrose . The iron sucrose dose was calculated from the following formula : weight before pregnancy ( kg ) × ( 110 g/L – actual hemoglobin [ g/L ] ) × 0.24 + 500 mg . Treatment efficacy was assessed by measuring hemoglobin and ferritin on the 14th and 28th days and at delivery , and the hemoglobin on the first postpartum day . Adverse drug reactions , fetal weight , hospitalization time , and blood transfusions were also recorded . RESULTS : Hemoglobin values varied significantly with time between groups ( interaction effect , P < .001 ) . The change in hemoglobin from baseline was significantly higher in the intravenous group than the oral group at each measurement ; the changes with respect to subsequent hemoglobin were significantly higher on the 14th ( P = .004 ) and 28th ( P = .031 ) days . Ferritin values were higher in patients receiving intravenous iron throughout pregnancy . No serious adverse drug reactions were observed . Fetal weight and hospitalization time were similar in the 2 groups . Blood transfusion was required for only one patient in the oral group . CONCLUSION : Intravenous iron treated iron-deficiency anemia of pregnancy and restored iron stores faster and more effectively than oral iron , with no serious adverse reactions . LEVEL OF EVIDENCE : Acute mountain sickness ( AMS ) is a common and disabling condition that occurs in healthy individuals ascending to high altitude . Based on the ability of iron to influence cellular oxygen sensing pathways , we hypothesized that iron supplementation would protect against AMS . To examine this hypothesis , 24 healthy sea-level residents were r and omized to receive either intravenous iron(III)-hydroxide sucrose ( 200 mg ) or saline placebo , before ascending rapidly to Cerro de Pasco , Peru ( 4340 m ) . The Lake Louise scoring system was used to assess incidence and severity of AMS at sea level and on the first full day at altitude . No significant difference in absolute AMS score was detected between the two groups either at baseline or at high altitude . However , the mean increase in AMS score was 65 % smaller in the iron group than in the saline group ( p<0.05 ) , and the change in AMS score correlated negatively with the change in ferritin ( R=-0.43 ; p<0.05 ) . Hematocrit and arterial oxygen saturation were unaffected by iron . In conclusion , this preliminary r and omized , double-blinded , placebo-controlled trial suggests that intravenous iron supplementation may protect against the symptoms of AMS in healthy volunteers OBJECTIVE ( 1 ) To determine an alternative iron supplementation with better efficacy , compliance & safety in treatment of iron deficiency anemia during pregnancy , ( 2 ) to reduce blood transfusion during pregnancy , labor and puerperium . MATERIAL AND METHOD A prospect i ve comparative study . A total number of 60 pregnant women with the gestational age of 12 - 34 weeks were included in the study who were suffering from iron deficiency anemia . They were divided in 3 groups ( A , B and C ) . Group A ( n = 15 ) received intravenous iron sucrose according to recommended dose containing 500 mg of iron sucrose for storage , in group B ( n = 20 ) iron sucrose was administered according to deficit calculated as per formula but 200 mg of iron was given for storage instead of 500 mg , to reduce cost . While group C received intra muscular iron Sorbitol in the dose used as practice . RESULTS Mean hemoglobin in group A and B was 8.0 + /- 1.1 g/dl and 8.9 + /- 0.7 respectively , in group C , it was 8.8 + /- 0.9 g/dl . In group A & B initial hemoglobin was assessed 3 weeks post therapy which showed an average rise of 2.8 g/dl ( group A ) and 1.9 g/dl ( group B ) and second assessment of Hemoglobin was done prior to delivery ( ave : 6.6 weeks ) showed a total rise of 3.8 g/dl ( group A ) and 2.4 g/dl ( group B ) . Pre delivery mean Hemoglobin in group A and B was 11.8 g/dl and 11.3 g/dl respectively . In group C , the Hemoglobin was assessed only prior to delivery ( average : 8.4 weeks from the start of therapy ) , and a rise of 1.4 g/dl was observed with pre delivery mean Hemoglobin of 10.2 g/dl . Target hemoglobin levels i.e. 11 g/dl was achieved by 80 % in Group A , 70 % in Group B and 28 % in Group C by the time of delivery . Blood transfusion was not required in any group . In group A and B one patient had moderate abdominal pain , 2 had weakness and shivering and 3 had phlebitis at the site where intravenous canula was retained . None of patient discontinued the therapy due to any adverse effect . In group C majority complained of pain at injection site while 5 patients dropped out from the study due to intolerance . CONCLUSION Intravenous iron therapy is safe , convenient and more effective then intramuscular iron therapy in treatment of iron deficiency anemia during pregnancy . The intravenous iron therapy can replace blood transfusion in antenatal period OBJECTIVES Anaemia is a frequent complication after cardiopulmonary bypass surgery .  Iron therapy has been variably employed by medical centres over the years . In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia , and its impact on blood transfusion requirements , in patients undergoing cardiopulmonary bypass surgery . METHODS A double-blind , r and omized , placebo-controlled clinical trial with three parallel groups of patients . Group I ( n = 54 ) : intravenous iron(III)-hydroxide sucrose complex , three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge . Group II ( n = 53 ) : oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge , and intravenous placebo while hospitalized . Group III ( n = 52 ) : oral and intravenous placebo pre- and postoperatively , following the same protocol . Data were collected preoperatively , at theatre , at intensive care unit admission , before hospital discharge and 1 month later . RESULTS ( 1 ) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups ; ( 2 ) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period ; ( 3 ) the intravenous iron group showed higher serum ferritin levels at hospital discharge ( 1321 ± 495 ng/ml ; P < 0.001 ) and 1 month later ( 610 ± 387 ; P < 0.001 ) compared with the other groups and ( 4 ) we did not observe statistical differences in blood transfusion requirements between the three groups . CONCLUSIONS The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements . [ Current Controlled Trials number : NCT01078818 ( oral and intravenous iron in patients postoperative cardiovascular surgery under EC ) ] Background : The aim of this study was to compare the efficacy , safety and achievement of the target hemoglobin level ( Hb ≥10 g/dl ) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management . Methods : Seventy-six patients with Hb levels < 9.0 g/dl who were scheduled to undergo surgical treatment were r and omized to receive either intravenous iron sucrose ( based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week , beginning 3 weeks before surgery ) or oral iron ( 80 mg/day of oral iron protein succinylate daily ) . Results : The intravenous iron group had higher increases in Hb ( 3.0 vs. 0.8 g/dl ; p < 0.0001 ) and ferritin levels ( 170.1 vs. 4.1 μg/l ; p < 0.0001 ) than the oral iron group . Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group ( 76.7 vs. 11.5 % ; p < 0.0001 ) . There were tolerable adverse events in both groups . Conclusion : Preoperative intravenous iron sucrose administration is more effective  than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents ( ESA ) , r and omized , controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis ( PD ) patients . In a multicenter trial , patients who had anemia , PD-dependent chronic kidney disease , stable ESA therapy , and a broad range of iron status ( ferritin < or = 500 ng/ml , transferrin saturation < or = 25 % ) were r and omly assigned to receive either 1 g of iron sucrose intravenously in three divided doses ( 300 mg over 1.5 h on days 1 and 15 , 400 mg over 2.5 h on day 29 ) or no supplemental iron . No serious adverse drug events occurred after intravenous iron administration . The primary end point , peak hemoglobin increase , was higher ( 1.3 + /- 1.1 versus 0.7 + /- 1.1 , mean + /- SD ; P = 0.0028 ) , and anemia intervention ( transfusion , increase in ESA dose , or intravenous iron therapy not called for in protocol ) occurred later ( P = 0.0137 ) and less often in intravenous iron-treated patients compared with untreated control subjects ( one of 66 [ 1.3 % ] versus five of 30 [ 16.7 % ] ) . Among patients who did not require intervention , iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects . Baseline iron status did not predict responsiveness to intravenous iron therapy . Intravenous iron sucrose is an effective adjunct to ESA therapy in anemic patients with PD-dependent chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of iron deficiency at baseline is not required to demonstrate intravenous iron efficacy Background . Iron deficiency is a common cause of anaemia and hyporesponsiveness to erythropoiesis-stimulating agents ( ESAs ) in non-dialysis-dependent chronic kidney disease ( ND-CKD ) patients .  Current intravenous iron agents can not be administered in a single high dose because of adverse effects . Ferric carboxymaltose , a non-dextran parenteral iron preparation , can be rapidly administered in high doses . Methods . This open-label trial r and omized 255 subjects with glomerular filtration rates ≤ 45 mL/min/1.73 m2 , haemoglobin ≤ 11 g/dL , transferrin saturation ≤ 25 % , ferritin ≤ 300 ng/mL , and stable ESA dose to either intravenous ferric carboxymaltose 1000 mg over 15 min ( with up to two additional doses of 500 mg at 2-week intervals ) or oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days . Results . In the modified intent-to-treat population , the proportion of subjects achieving a haemoglobin increase ≥ 1 g/dL at any time was 60.4 % with ferric carboxymaltose and 34.7 % with oral iron ( P < 0.001 ) . At Day 42 , mean increase in haemoglobin was 0.95 ± 1.12 vs 0.50 ± 1.23 g/dL ( P = 0.005 ) , mean increase in ferritin was 432 ± 189 ng/mL vs 18 ± 45 ng/mL ( P < 0.001 ) and mean increase in transferrin saturation was 13.6 ± 11.9 % vs 6.1 ± 8.1 % ( P < 0.001 ) . Treatment-related adverse events were significantly fewer with ferric carboxymaltose than with oral iron ( 2.7 % and 26.2 % , respectively ; P < 0.0001 ) . Conclusions . We conclude that 1000 mg ferric carboxymaltose can be rapidly administered , is more effective and is better tolerated than oral iron for treatment of iron deficiency in ND-CKD patients Patients undergoing maintenance hemodialysis have elevated markers of oxidative stress , but the reasons for this are not fully understood . Intravenous administration of iron , which many of these patients receive , may provoke the generation of bioactive iron , which enhances oxidative stress and lipid peroxidation . In this study , 110 hemodialysis patients were r and omly assigned to five groups that were administered single intravenous doses of iron sucrose , ranging from 20 to 500 mg . A time- and dosage-dependent rise in lymphocyte 8-hydroxy-2'-deoxyguanosine ( 8-OHdG ) levels in lymphocyte DNA , a marker of oxidative DNA damage , with a significant increase at 2 h after intravenous iron of > or = 200 mg ( P < 0.05 ) . Four weeks later , patients were r and omly assigned to weekly iron sucrose ( 100 mg of elemental iron ) or saline for 12 wk , and 89 patients completed the study . Mean lymphocyte 8-OHdG content was significantly higher in patients receiving intravenous iron compared with control subjects ( P < 0.05 ) , especially in those with ferritin levels > 500 microg/L. In addition , flow cytometric techniques revealed increased production of reactive oxygen species in lymphocytes among those treated with intravenous iron . Treatment with intravenous iron but not saline was also associated with decreased plasma ascorbate and alpha-tocopherol levels and increased oxidized glutathione/reduced glutathione ratio ( P < 0.05 ) . In summary , intravenous iron sucrose provokes oxidative damage to peripheral blood lymphocyte DNA in hemodialysis patients , especially among those with high levels of ferritin This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration . In a r and omized , double-blinded , placebo-controlled study , 90 premenopausal women presenting with fatigue , serum ferritin ≤ 50 ng/mL , and hemoglobin ≥ 120 g/L were r and omized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose or intravenous placebo . Fatigue and serum iron status were assessed at baseline and after 6 and 12 weeks . Median fatigue at baseline was 4.5 ( on a 0 - 10 scale ) . Fatigue decreased during the initial 6 weeks by 1.1 in the iron group compared with 0.7 in the placebo group ( P = .07 ) . Efficacy of iron was bound to depleted iron stores : In patients with baseline serum ferritin ≤ 15 ng/mL  , fatigue decreased by 1.8 in the iron group compared with 0.4 in the placebo group ( P = .005 ) , and 82 % of iron-treated compared with 47 % of placebo-treated patients reported improved fatigue ( P = .03 ) . Drug-associated adverse events were observed in 21 % of iron-treated patients and in 7 % of placebo-treated patients ( P = .05 ) ; none of these events was serious . Intravenous administration of  iron improved fatigue in iron-deficient , nonanemic women with a good safety and tolerability profile . The efficacy of intravenous iron was bound to a serum ferritin concentration ≤ 15 ng/mL. This study was registered at the International St and ard R and omized Controlled Trial Number Register ( www.is rct n.org ) as IS RCT N78430425 BACKGROUND This study was performed to evaluate the capacity of oral and intravenous ( i.v . ) iron administration during autologous blood donation ( ABD ) to improve the efficacy of ABD and to prevent the need for allogeneic blood transfusion in patients without iron deficiency who are undergoing major elective surgery for which a minimum of 3 autologous units have been ordered . STUDY DESIGN AND METHODS One hundred twenty-three patients were enrolled in an open-labeled , r and omized , controlled trial and assigned to three treatment groups : patients in Group 1 received 3 x 100 mg of Fe2 + per day given orally for 5 weeks before operation ; patients in Group 2 received 200 mg of Fe3 + given intravenously after each donation combined with initial i.v . iron supplementation in patients with hemoglobin under 15 g per dL ; and patients in Group 3 were in the  control group  that received no iron medication . A modest ABD program involving weekly phlebotomy and threshold hemoglobin values for donation of 11.5 g per dL in women and 12.0 g per dL in men was performed . RESULTS Ninety patients , 15 women and 15 men in each of the three groups , completed the study . The mean net red cell production during ABD was no higher ( p>0.2 ) in the iron-treated groups ( Group 1 : 473 + /- 178 mL ; Group 2 : 436 + /- 170 mL ; Group 3 ( controls ) : 397 + /- 174 mL ) . The mean number of autologous units donated per patient did not differ ( p>0.7 ) among the groups ( Group 1 : 3.1 + /- 0.6 ; Group 2 : 2.9 + /- 0.7 ; Group 3 : 3.0 + /- 0.7 ) . The proportion of patients who needed allogeneic blood transfusion showed no significant ( p>0.4 ) advantage for iron treatment , ( Group 1 : 7 % ; Group 2 : 20 % ; Group 3 : 10 % ) . CONCLUSION In non-iron-deficient patients undergoing modest ABD without erythropoietin therapy , neither oral nor i.v . application of iron during the preoperative period enhances the success of preoperative ABD PURPOSE Functional iron deficiency may impair response to erythropoiesis-stimulating agents ( ESAs ) in iron-replete patients with chemotherapy-associated anemia ( CAA ) . This study evaluated whether coadministration of parenteral iron improves ESA efficacy in patients with CAA . PATIENTS AND METHODS This prospect i ve , multicenter , r and omized trial enrolled 502 patients with hemoglobin ( Hb ) less than 11 g/dL who were undergoing chemotherapy for nonmyeloid malignancies . All patients received darbepoetin alfa once every 3 weeks and were r and omly assigned to receive either ferric gluconate 187.5 mg intravenously ( IV ) every 3 weeks , oral daily ferrous sulfate 325 mg , or oral placebo for 16 weeks . RESULTS There was no difference in the erythropoietic response rate ( ie , proportion of patients achieving Hb ≥ 12 g/dL or Hb increase ≥ 2 g/dL from baseline ) : 69.5 % ( 95 % CI , 61.9 % to 76.5 % ) of IV iron-treated patients achieved an erythropoietic response compared with 66.9 % ( 95 % CI , 59.1 % to 74.0 % ) who received oral iron and 65.0 % ( 95 % CI , 57.2 % to 72.3 % ) who received oral placebo ( P = .75 ) . There were also no differences in the proportion of patients requiring red cell transfusions , changes in quality of life , or the dose of darbepoetin administered . Adverse events ( AEs ) tended to be more common in the IV iron arm : grade 3 or higher AEs occurred in 54 % ( 95 % CI , 46 % to 61 % ) of patients receiving IV iron compared with 44 % ( 95 % CI , 36 % to 52 % ) who received oral iron and 46 % ( 95 % CI , 38 % to 54 % ) who received oral placebo ( P = .16 ) . CONCLUSION In patients with CAA , addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo Background : Secondary thrombocytosis is a common clinical feature . In patients with cancer , it is a risk factor for venous thromboembolic events . In inflammatory bowel disease ( IBD ) , thrombocytosis is so far considered a marker of active disease and may contribute to the increased thromboembolic risk in this population . Observed effects of iron therapy on normalization of platelet counts led us to hypothesize that iron itself may regulate megakaryopoiesis . Here , we want to test the effect of iron replacement on platelet count and activity in IBD-associated thrombocytosis . Methods : We performed a r and omized , single-blinded placebo-controlled trial testing the effect of ferric carboxymaltose ( FCM ) in patients with IBD with secondary thrombocytosis ( platelets > 450 G/L ) . Changes in platelet counts , hemoglobin , iron parameters , disease activity , megakaryopoietic growth factors , erythropoietin , and platelet activity were assessed . Patients received placebo or up to 1500 mg iron as FCM . Endpoints were evaluated at week 6 . Results : A total of 26 patients were included in the study , 15 patients were available for the per protocol analysis . A drop in platelets > 25 % ( primary endpoint ) was observed in 4 of 8 ( 50 % , iron group ) and 1 of 7 patients ( 14 % , placebo group , P = 0.143 ) . Mean platelet counts dropped on FCM but not on placebo ( 536 G/L to 411 G/L versus 580 G/L to 559 G/L ; P = 0.002 ) . Disease activity and megakaryopoietic growth factors remained unchanged and hemoglobin and iron parameters increased on FCM . The normalization of platelet counts was associated with a decrease in platelet aggregation and P-selectin expression . Conclusion : FCM lowers platelet counts and platelet activation in patients with IBD-associated secondary thrombocytosis OBJECTIVES : Anemia is a frequent complication in patients with inflammatory bowel disease ( IBD ) . The optimal route for iron supplementation to replenish iron stores has not been determined so far . We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia ( IDA ) in patients with IBD . METHODS : A r and omized , prospect i ve , open-label , multicenter study was performed in 46 patients with anemia and transferrin saturation ≤20 % and /or serum ferritin concentrations ≤20 μg/L. The intravenous group received a single dose of iron sucrose of 7 mg iron/kg body weight , followed by five 200 mg infusions for the following 5 wks . The oral group received iron sulfate 100–200 mg per day for 6 wks . RESULTS : While a comparable increase in hemoglobin was observed for both administration routes ( median increase 0.25 g/L in the intravenous group vs 0.21 g/L in the oral group ) , only iron sucrose led to a rise in serum ferritin concentrations . Intractable gastrointestinal adverse events caused permanent study drug discontinuation in five patients ( 20.8 % ) receiving iron sulfate , whereas only one patient ( 4.5 % ) had to be withdrawn because of side effects due to iron sucrose . CONCLUSIONS : Although being equal in short-term efficacy and overall tolerability our results suggest a better gastrointestinal tolerability for iron sucrose . Larger trials are m and atory to prove a possible advantage of iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD OBJECTIVES : In the largest head-to-head comparison between an oral and an intravenous ( IV ) iron compound in patients with inflammatory bowel disease ( IBD ) so far , we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia ( IDA ) . METHODS : This prospect i ve , r and omized , comparative , open-label , non-inferiority study was conducted at 36 sites in Europe and India . Patients with known intolerance to oral iron were excluded . A total of 338 IBD patients in clinical remission or with mild disease , a hemoglobin ( Hb ) < 12 g/dl , and a transferrin saturation ( TSAT ) < 20 % were r and omized 2:1 to receive either IV iron isomaltoside 1,000 according to the Ganzoni formula ( 225 patients ) or oral iron sulfate 200 mg daily ( equivalent to 200 mg elemental iron ; 113 patients ) . An interactive web response system method was used to r and omize the eligible patient to the treatment groups . The primary end point was change in Hb from baseline to week 8 . Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of −0.5 g/dl . The secondary end points , which tested for superiority , included change in Hb from baseline to weeks 2 and 4 , change in s-ferritin , and TSAT to week 8 , number of patients who discontinued study because of lack of response or intolerance of investigational drugs , change in total quality of life ( QoL ) score to weeks 4 and 8 , and safety . Exploratory analyses included a responder analysis ( proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks ) , the effect of regional differences and total iron dose level , and other potential predictors of the treatment response . RESULTS : Non-inferiority in change of Hb to week 8 could not be demonstrated . There was a trend for oral iron sulfate being more effective in increasing Hb  than iron isomaltoside 1,000 . The estimated treatment effect was −0.37 ( 95 % confidence interval ( CI ) : −0.80 , 0.06 ) with P=0.09 in the full analysis set ( N=327 ) and −0.45 ( 95 % CI : −0.88 , −0.03 ) with P=0.04 in the per protocol analysis set ( N=299 ) . In patients treated with IV iron isomaltoside 1,000 , the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 ( 95 % CI : 18.6 , 78.8 ) with P=0.002 , whereas the mean change in TSAT was lower with an estimated treatment effect of −4.4 ( 95 % CI : −7.4 , −1.4 ) with P=0.005 , compared with patients treated with oral iron . No differences in changes of QoL were observed . The safety profile was similar between the groups . The proportion of responders with Hb ≥2 g/dl ( IV group : 67 % ; oral group : 61 % ) were comparable between the groups ( P=0.32 ) . Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of > 1,000 mg IV . Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein ( CRP ) . CONCLUSIONS : We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study . Based on the dose – response relationship observed with the IV iron compound , we suggest that the true iron dem and of IV iron was underestimated by the Ganzoni formula in our study . Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD BACKGROUND AND OBJECTIVES Iron depletion is common in regular blood donors . The objective of the study was to investigate the frequency and severity of iron depletion in regular blood donors and whether IV iron is more effective than oral to avoid iron depletion and symptoms thereof , especially restless legs syndrome ( RLS ) . METHOD One hundred and twenty blood donors with at least five previous whole blood donations were r and omized to receive either IV iron sucrose ( Venofer ( ® ) , RenaPharma/Vifor , Uppsala , Sweden ) , 200 mg , or to 20 × 100 mg of oral iron sulphate ( Duroferon ( ® ) , GlaxoSmithKline , Stockholm , Sweden ) , after each blood donation during 1 year . Iron status and RLS incidence and severity were investigated . RESULTS Iron status was generally poor among regular blood donors , especially in women , with a high incidence of iron depletion ( > 20 % ) and RLS ( 18 % ) . The IV iron group increased storage iron to a greater extent than the oral iron group after 12 months ( P=0·0043 ) . Female donors were more responsive to IV iron sucrose compared to oral iron sulphate , particularly female donors below 50 years of age . RLS severity scores were significantly lower in the IV iron group . The two treatments were safe . CONCLUSION Iron status is poor in regular blood donors , restless legs syndrome is common , and the routine iron supplementation is insufficient . IV iron sucrose  substitutes iron loss in blood donors more efficiently compared with oral iron sulphate , especially in women . Iron substitution to blood donors should be individualized and based on P-ferritin monitoring Sensitivity to iron dextran is a potent obstacle to maintaining optimum iron status in patients with dialysis-associated anemia . As part of the North American clinical trials for iron sucrose injection , we examined the effect of intravenous ( IV ) iron sucrose in 23 hemodialysis patients with documented sensitivity to iron dextran , ongoing epoetin alfa therapy , and below-target-range hemoglobin ( Hgb ) levels ( < 11.0 g/dL ) . We assigned patients to treatment groups according to whether reactions they had experienced to iron dextran were judged to be mild ( n = 16 ; group A ) or severe ( n = 7 ; group B ) . We prospect ively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment . We administered iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients . We did not administer a test dose . Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose ( 184 doses by IV push , 39 doses by IV infusion ) . Intradialytic blood pressure changes after IV iron sucrose injection did not differ from those recorded during dialysis sessions without treatment . An increase in values for Hgb , hematocrit , transferrin saturation , and ferritin , coupled with no significant change in  epoetin dose and a decrease in total iron-binding capacity , confirmed the efficacy of iron sucrose injection in managing anemia . We conclude that iron sucrose injection is safe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion BACKGROUND Correction of iron deficiency is critical in chronic hemodialysis patients , and intravenous administration is superior to the oral route in this goal . Recently , concern was raised that intravenous iron administration might promote infection in dialysis patients . METHODS We review ed the data from a recent prospect i ve study of 985 patients in which no link between iron therapy and bacteremia had been found . We tested the potential role of the administration route of the iron ( intravenous vs. oral ) , the weekly amount of iron administered and the administration rate on the risk for bacteremia in these patients . RESULTS were 4-fold : in multivariate analysis , neither intravenous iron administration in the whole population nor the weekly amount of iron in the subgroup of i.v . iron-treated patients were significant risk factors for bacteremia ;  iron was not given more frequently intravenously in bacteremic than in non-bacteremic patients ; among patients treated with intravenous iron , the frequency and the amount of iron administered were significantly higher in those who developed bacteremia than in those who did not ; and in patients receiving i.v . iron , there was an increased risk of bacteremia associated with concurrent administration of erythropoietin , which was not observed in patients receiving iron orally . CONCLUSION This study failed to demonstrate a significant association between intravenous iron administration and the risk of bacteremia in dialysis patients . However , there might be a slightly increased risk of bacteremia in patients given high-frequency , high-dose intravenous iron OBJECTIVE The aim of this study was to ascertain whether high-dose intravenous ( IV ) iron sucrose could improve symptoms and change brain iron concentrations in idiopathic RLS . METHODS The study was a r and omized , parallel-group double-blind study of 1000 mg iron sucrose given IV versus placebo . Primary measures of the clinical status were global rating scale ( GRS ) and periodic leg movements of sleep ( PLMS ) . Primary measures of brain iron status were CSF ferritin and MRI-determined iron in the substantia nigra . RESULTS At the time of the interim analysis there were 7 placebo and 11 iron-treated subjects . At 2-weeks post-treatment , iron treatment result ed in a small but significant increase in CSF ferritin and a decrease in RLS severity ( GRS ) but did not change PLMS or MRI iron index . None of the secondary outcomes changed with treatment . There was no single case of clear treatment benefit in any of the patients . This interim analysis revealed an effect size that was too small to allow for adequate power to find significant differences with the planed 36-subject enrollment for either the primary objective outcome of PLMS or any of the secondary outcomes . The study was stopped at this planned break-point given the lack of both adequate power and any indication for clinical ly significant benefit . CONCLUSIONS High-dose IV iron failed to demonstrate the robust changes reported in three prior open-label studies . Differences in iron formulation , dosing regiment , and peripheral iron status may explain some of the discrepancies between this and previous IV iron treatment studies Although oral iron is the initial treatment approach for iron deficiency anemia ( IDA ) , some patients fail to respond to or can not tolerate oral iron . This double‐blind safety and efficacy study of the intravenous ( IV ) iron , ferumoxytol , r and omized patients with a history of unsatisfactory oral iron therapy , or in whom oral iron could not be used ,  to ferumoxytol ( n = 609 ) or placebo ( n = 203 ) . The proportion of patients achieving the primary endpoint ( hemoglobin increase ≥2.0 g/dL at Week 5 ) was 81.1 % with ferumoxytol versus 5.5 % with placebo ( P < 0.0001 ) . The mean increase in hemoglobin from Baseline to Week 5 , a secondary endpoint ( also the alternative preplanned primary efficacy endpoint for other health authorities ) , was 2.7 versus 0.1 g/dL ( P < 0.0001 ) . Achievement of a hemoglobin ≥12 g/dL , time to a hemoglobin increase ≥2.0 g/dL , and improvement in the Functional Assessment of Chronic Illness Therapy Fatigue score also significantly favored ferumoxytol over placebo at Week 5 (  P < 0.0001 ) . Ferumoxytol treatment‐emergent adverse events were mainly mild to moderate . Ferumoxytol was effective and well tolerated in patients with IDA of any underlying cause in whom oral iron was ineffective or could not be used . This trial was registered at www . clinical trials.gov as # NCT01114139 . Am . J. Hematol . 89:7–12 , 2014 . © 2013 Wiley Periodicals , Iron deficiency anemia is common among hospitalized patients , and blood losses from diagnostic phlebotomy increase the likelihood of a negative iron balance . The role for iron supplementation of total parenteral nutrition ( TPN ) in these patients is unclear . Twenty-three patients with iron deficiency anemia were identified . Twelve patients were r and omized to receive TPN without iron ( group 1 ) and 11 received TPN supplemented with 10 mg of iron as iron dextran daily ( group 2 ) . Both groups were matched for age , serum iron studies , red cell indices , and hemogram . After a 7-d period , the mean serum iron in group 2 increased from 10 to 26 micrograms/dL , with an increased transferrin saturation from 7.3 to 15.3 % ( each , p < 0.05 ) . No changes in total iron binding capacity , ferritin , reticulocyte count , hemoglobin , hematocrit , or mean corpuscular volume were observed in the two groups . The incidence of infectious complications was not different between both groups . We conclude that iron supplementation of TPN appears safe and is effective in increasing serum iron levels . The use of iron-supplemented short-term TPN needs to be further studied given no change in red cell indices , hemoglobin , hematocrit , or transfusion requirement There is limited safety information about ferric carboxymaltose ( FCM ) , a new intravenous iron preparation . This r and omized , crossover study compared the safety and tolerability of double‐blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia . Subjects ( 559 ) with iron deficiency anemia received a dose of either FCM ( 15 mg/kg , maximum 1000 mg ) over 15 minutes or placebo on day 0 . On day 7 , subjects received the other agent . Safety evaluations were performed on days 7 and 14 . The primary endpoint was the incidence of treatment‐emergent adverse events during each 7‐day study period . During the first 24 hours and during the 7‐day treatment period , at least one treatment‐emergent adverse event was experienced by 15.0 % and 29.3 % of subjects after FCM and 11.4 % and 19.7 % after placebo , respectively . Most were classified as Grade 1 or 2 . Six subjects had Grade 3 treatment‐emergent adverse events  after FCM and 9 subjects after placebo . One subject had a Grade 4 , and 1 subject had a Grade 5 treatment‐emergent adverse event , but neither was considered study drug‐related . During the first 24 hours of the treatment period , drug‐related adverse events were reported in 9.3 % of subjects receiving FCM and 4.8 % receiving placebo . Of drug‐related Grade 3 events , 4 subjects received FCM and 5 subjects received placebo . Administration of FCM ( 15 mg/kg , maximum of 1000 mg ) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia Oral and intravenous iron were compared in patients treated with renal dialysis by a cross-over trial . Intravenous iron was given over 2 weeks as an iron dextran ( equivalent to 100 mg elemental iron ) . Oral iron was given daily as ferrous sulphate ( equivalent to 100 mg elemental iron ) in a wax matrix tablet . Each treatment period lasted 26 weeks . There was no significant difference in therapeutic or unwanted effects between the treatments Background . Anemia after kidney transplantation has been associated with poor transplant outcomes . We hypothesized that intravenous ( IV ) iron may more rapidly correct anemia than oral ( PO ) iron . Methods . One hundred four kidney transplant recipients were prospect ively  r and omized to IV iron polymaltose ( 500 mg single dose ) or PO ferrous sulfate ( 210 mg elemental iron daily , continuously ) . The primary outcome was time to resolution of anemia , defined as hemoglobin more than or equal to 11 g/dL. Secondary outcomes included infections , blood transfusions , gastrointestinal side-effects , and acute rejection . Results . There was no significant difference in the primary outcome comparing IV with PO iron ( hazards ratio 1.22 ; 95 % confidence interval 0.82–1.83 ; P=0.32 ) . The median time to resolution of anemia was 12 days in the IV group versus 21 days in the PO group . There were no differences in infections ( 20 % vs. 24 % , P=0.62 ) , acute rejection ( 8 % vs. 6 % , P=0.68 ) , blood transfusions ( 10 % vs. 18 % , P=0.24 ) , and severe gastrointestinal side-effects ( 6 % vs. 12 % , P=0.29 ) between the IV iron and the PO iron groups . Conclusions . We conclude that a single dose of IV iron did not result in more rapid resolution of anemia compared with PO iron . Both IV and PO iron are safe and effective in the management of posttransplant anemia To compare two modalities of iron supplementation for the preoperative stimulation of erythropoiesis using recombinant human erythropoietin ( rhEPO ) , 12 adults in normal hemoglobin and iron status due for elective surgery were r and omized to rhEPO 200 U/kg body weight subcutaneously twice weekly combined with either iron sucrose 200 mg intravenously twice weekly or iron sulfate 160 mg/day orally , for 3 weeks preoperatively . Efficacy was measured by the increases over baseline in hemoglobin , reticulocyte count , and ferritin determined 3 days before surgery ; preoperative reticulocyte count and ferritin were significantly higher with intravenous iron , whereas the only significant intragroup increases in hemoglobin between time points also occurred in this group . Intravenous iron significantly boosts the hematopoietic response to rhEPO and prevents iatrogenic iron depletion in otherwise healthy c and i date s for elective surgery OBJECTIVE To compare the incidence of repeated red blood cell ( RBC ) transfusion in anemic gynecologic cancer patients receiving platinum-based chemotherapy comparing intravenous and oral iron . MATERIAL S AND METHODS Forty-four anemic gynecologic cancer patients ( hemoglobin level below 10 mg/dl ) who required RBC transfusion were stratified and r and omized according to baseline hemoglobin levels and chemotherapy regimen . Study group received 200 mg of intravenous iron sucrose and control group received oral ferrous sulphate 600 mg/day . RBC transfusion requirement in the consecutive cycle of chemotherapy was the primary outcome . Quality of life was evaluated by vali date d Thai version of the Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) . RESULTS In a total of the 44 patients , there were 22 patients in each group . Five patients ( 22.7 % ) in the study group and 14 patients ( 63.6 % ) in the control group required RBC transfusion in consecutive cycle of chemotherapy ( p=0.01 ) . No significant difference in baseline hemoglobin and hematocrit levels was demonstrated in both groups . Significantly higher mean hemoglobin and hematocrit levels after treatment were reported in the study group ( 10.0+/-0.8 g/dl and 30.5+/-2.4 % ) than the control group ( 9.5+/-0.9 g/dl and 28.4+/-2.7 % ) . No significant change of total FACT-An scores was noted between before and after treatment in both groups . No serious adverse events were reported and there was no significant difference among adverse events between both groups . CONCLUSION Intravenous iron is an alternative treatment for anemic gynecologic cancer patients receiving platinum-based chemotherapy and reduces the incidence of RBC transfusion without serious adverse events Objective . Iron therapy may reinforce intestinal inflammation by catalysing production of reactive oxygen species . The effects of oral ferrous fumarate and intravenous iron sucrose on clinical disease activity and plasma redox status were investigated in patients with inflammatory bowel disease ( IBD ) . Material and methods . Nineteen patients with iron deficiency anaemia and Crohn 's disease ( 11 ) or ulcerative colitis ( 8) were included in a crossover study . The patients were r and omly assigned to start treatment with ferrous fumarate ( Neo-fer ® ) 120 mg orally once daily or iron sucrose ( Venofer ® ) 200 mg intravenously 3 times during a period of 14 days . Clinical disease activity assessment and blood and faecal analysis were performed on days 1 and 15 . Results . Following oral ferrous fumarate  clinical disease activity ( p=0.037 ) , general well-being score ( i.e. patients felt worse ) ( p=0.027 ) and abdominal pain score ( p=0.027 ) increased , while no changes were seen following iron sucrose  treatment . C-reactive protein ( CRP ) and faecal calprotectin were unchanged after both treatments . As compared with iron sucrose , ferrous fumarate  increased Crohn 's disease activity index ( CDAI ) scores of general well-being ( p=0.049 ) , whereas alterations in clinical disease activity ( p=0.14 ) and abdominal pain score ( p=0.20 ) did not differ . Ferrous fumarate did not significantly alter plasma malondialdehyde ( MDA ) or plasma antioxidants . Iron sucrose  increased plasma MDA ( p=0.004 ) and decreased plasma vitamin C ( p=0.017 ) and betacarotene ( p=0.008 ) . Conclusions . Oral ferrous fumarate , but not intravenous iron sucrose , increased clinical disease activity in IBD patients .  Intravenous iron sucrose  increased intravascular oxidative stress BACKGROUND An optimal haemoglobin ( Hb ) response to erythropoietin requires elevated iron indices in dialysis patients ; however , it is unknown if the same applies in chronic kidney disease ( CKD ) . METHODS One hundred patients [ CKD Stages 3 - 5 , Hb > or= 110 g/L , iron replete , erythropoietin-stimulating agent (ESA)-naive , 47 % diabetic , median age 69.5 years ] were block-r and omized in an open-label study to receive up to 200 mg intravenous iron sucrose ( Group A , n = 52 ) bimonthly or oral iron sulphate ( Group B ) to maintain raised and normal iron indices ( respectively ) over 12 months . The primary endpoint was the change in Hb concentration at 12 months or at termination after at least 6 months of treatment . RESULTS Eighty-five patients reached the primary endpoint ( 43 , Group A ; 42 , Group B ) . Initial Hb was 119 + /- 7 vs 116 + /- 12 g/L ( mean + /- st and ard deviation ) ; ferritin 122 ( 71 - 176 ) , median ( inter-quartile range ) , vs 90 microg/L ( 58 - 150 ) ; transferrin saturation ( TSat ) 22 ( 18 - 26 ) vs 21 % ( 15 - 24 ) ; and creatinine 240 ( 195 - 313 ) vs 230 micromol/L ( 184 - 352 ) . Ferritin and TSat differed by month 2 [ 157 ( 103 - 220 ) vs 96 microg/L ( 73 - 162 ) , P = 0.003 ] and month 6 [ 25 ( 20 - 31 ) vs 21 % ( 17 - 27 ) , P = 0.02 ] , respectively . At study end , Hb did not differ between groups ( 121 + /- 10 vs 117 + /- 13 g/L ) . Ferritin was 362 ( 310 - 458 ) vs 125 microg/L ( 84 - 190 ) , P < 0.001 ; TSat 30 ( 23 - 34 ) vs 21 % ( 18 - 24 ) , P < 0.001 ; and creatinine 229 ( 188 - 326 ) vs 272 micromol/L ( 195 - 413 ) , P = NS . For patients ( Groups A and B , n = 27 in each group ) whose creatinine regression slope increased ( indicating worsening function ) , the fall in Hb over 12 months also did not differ between groups despite adequate separation in iron indices . Serious adverse events overall did not differ between groups . CONCLUSIONS Elevated iron indices did not increase Hb synthesis in ESA-naive , iron replete , pre-dialysis patients with Hb > 110 Background Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease ( ND-CKD ) but it is unclear if oral supplementation is as effective as intravenous ( IV ) supplementation in re-establishing iron stores . The purpose of this study was to determine if oral Heme Iron Polypeptide ( HIP ) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD . Methods Forty ND-CKD patients were r and omized ; 18 to HIP  11 mg orally 3 times per day and 22 to IV iron sucrose 200 mg monthly for 6 months . Baseline clinical and laboratory data were collected for all patients . The primary and secondary outcomes for the study were hemoglobin ( Hgb ) concentration and iron indices [ ferritin and percentage transferrin saturation ( TSAT ) ] at the end of 6 months respectively . Adverse events were also compared . Results The baseline demographic characteristics and laboratory values were similar for the two groups . After 6 months of treatment , Hb in the  HIP  group was 117 g/L and 113 g/L in the IV sucrose group ( p = 0.37 ) . The TSAT at 6 months was not different between the two groups { p = 0.82}but the serum ferritin was significantly higher in the IV iron sucrose group { 85.5 ug/L in HIP and 244 ug/L ; p = 0.004}. Overall adverse events were not different between the groups . Conclusion HIP is similar in efficacy to IV iron sucrose in maintaining hemoglobin in ND-CKD patients with no differences in adverse events over 6 months . It is unclear if the greater ferritin values in the IV iron sucrose group are clinical ly significant . Trial registration Clinical Trials.gov : OBJECTIVES To compare the safety and efficacy of iron carboxymaltose with ferrous sulfate to treat iron deficiency anemia in the post partum . METHODS Patients were r and omized ( 2:1 ratio ) to receive iron carboxymaltose  ( up to 3 weekly doses of 1000 mg maximum , applied in 15 min ; n=227 ) or ferrous sulfate ( 100 mg twice daily , 12 weeks ; n=117 ) . Changes in hemoglobin and iron stores up to week 12 were analyzed . RESULTS Iron carboxymaltose was as effective as oral iron sulfate in changing hemoglobin , despite the much shorter treatment period ( 2 weeks vs 12 weeks ) . Ferritin levels were significantly higher . Except for injection site burning , iron carboxymaltose was better tolerated than ferrous sulfate , mainly concerning gastrointestinal side effects . There were no safety concerns identified in breast-fed infants . CONCLUSION Parenteral iron carboxymaltose is a safe and effective treatment option for postpartum anemia , with advantages of a shorter treatment period , better compliance , rapid normalization of iron storages , and lower incidence of gastrointestinal side effects Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits ( 1 ) . The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement , a checklist ( Table 1 ) flow diagram first published in 1996 and revised 5 years later ( 2 , 3 ) , is an effort to st and ardize , and thereby improve , published reports of r and omized , controlled trials ( RCTs ) . One of the additions to the 2001 revision was an item about reporting adverse events . This single item did not do full justice to the importance of harms-related issues . The CONSORT Group met in September 2001 to discuss how to correct this deficiency . We aim ed to provide evidence -based guidance on the reporting of harms in RCTs . First , we search ed MEDLINE , EMBASE , Web of Science , and the Cochrane Library using a wide array of terms related to harms and identified pertinent evidence . We also communicated with experts and review ed bibliographies of identified articles to find additional studies . At a meeting in Montebello , Quebec , Canada , in May 2003 , CONSORT Group members , including several journal editors and additional experts in related fields , held a structured discussion of recommendations about reporting of harms-related issues in RCTs . The discussion s led to a written document that we circulated among the team members for comment . The present manuscript describes our recommendations on the appropriate reporting of harms in RCTs . Table 1 . Original CONSORT Checklist The terminology of harms-related issues in RCTs is confusing and often misleading or misused ( see Glossary ) ( 4 , 5 ) . Safety is a reassuring term that may obscure the real and potentially major harms that drugs and other interventions may cause . We encourage authors to use the term harms instead of safety . In addition to misused terminology , reporting of harms in RCTs has received less attention than reporting of efficacy and effectiveness and is often inadequate ( 6 - 14 ) . In short , both scientific evidence and ethical necessity call for action to improve the quality of reporting of harms in RCTs ( 15 , 16 ) . Here , we present a set of recommendations and accompanying explanations for the proper reporting of harms in RCTs . These recommendations should complement the existing CONSORT statement ( Table 2 ) . Examples are presented on the Annals and CONSORT ( www.consort-statement.org ) Web sites . Table 2 . Checklist of Items To Include When Reporting Harms in R and omized , Controlled Trials Recommendations Title and Abstract Recommendation 1 . If the study collected data on harms and benefits , the title or abstract should so state . The title should mention harms if the study of harms was a key trial objective . Many phase I and phase II trials , some phase II/III trials , and most phase IV trials ( 17 , 18 ) target harms as primary outcomes . Yet , the title and abstract seldom contain the word harm . Among 375143 entries in the Cochrane Central Register of Controlled Trials ( Cochrane Library , issue 3 , 2003 ) , search ing titles with the search terms harm or harms yielded 337 references ( compared with 55374 for efficacy and 23415 for safety ) . Of the 337 , excluding several irrelevant articles on self-harm or harm reduction , only 3 trial reports and 2 abstract s contained the word harm in their titles . Authors should present information on harms in the abstract . If no important harms occurred , authors should so state . Explicit reference to the reporting of adverse events in the title or abstract is also important for appropriate data base indexing and information retrieval ( 19 ) . Introduction Background Recommendation 2 . If the trial addresses both harms and benefits , the introduction should so state . The introduction states the scientific background and rationale of an RCT . This requires a balanced presentation whereby the possible benefits of the intervention under investigation are outlined along with the possible harms associated with the treatment . R and omized , controlled trials that focus primarily on harms should clearly state this interest when describing the study objectives in the Introduction and in defining these objectives in the Methods . Methods Outcomes Recommendation 3 . List addressed adverse events with definitions for each ( with attention , when relevant , to grading , expected vs. unexpected events , reference to st and ardized and vali date d definitions , and description of new definitions ) . The Methods section should succinctly define the recorded adverse events ( clinical and laboratory ) . Authors should clarify whether the reported adverse events encompass all the recorded adverse events or a selected sample . They should explain how , why , and who selected adverse events for reporting . In trials that do not mention harms-related data , the Methods section should briefly explain the reason for the omission ( for example , the design did not include the collection of any information on harms ) . Authors should also be explicit about separately reporting anticipated and unexpected adverse events . Expectation may influence the incidence of reported or ascertained adverse events . Making participants aware in the consent form of the possibility of a specific adverse event ( priming ) may increase the reporting rate of the event ( 20 ) . Another example of priming is the finding that the rates of withdrawals due to adverse events and the rates of specific adverse events were significantly higher in trials of aspirin , diclofenac , or indomethacin with comparator drugs compared with placebo-controlled trials ( 21 ) . Presumably , participants were more eager to come forth and report an adverse event or to withdraw from treatment when they knew they could not be receiving inactive placebo . Authors should report whether they used st and ardized and vali date d measurement instruments for adverse events . Several medical fields have developed st and ardized scales ( 22 - 32 ) . Use of nonvali date d scales is common . The source document for well-established definitions and scales should be referenced . New definitions for adverse events should be explicit and clear . Authors should describe how they developed and vali date d new scales . For interventions that target healthy individuals ( for example , many preventive interventions ) , any harm , however minor , may be important to capture and report because the balance of harms and benefits may easily lean toward harms in a low-risk population . For other population s and for interventions that improve major outcomes ( for example , survival ) , severe and life-threatening adverse events may be the only ones that are important in the balance of benefits and harms . Recommendation 4 . Clarify how harms-related information was collected ( mode of data collection , timing , attribution methods , intensity of ascertainment , and harms-related monitoring and stopping rules , if pertinent ) . It is important to describe the question naires , interviews , and tests used to collect information on harms , as well as their timing during follow-up . Passive surveillance of harms leads to fewer recorded adverse events than active surveillance ( 4 ) . Open-ended questions may yield different information , both quantitatively and qualitatively , than structured question naires ( 33 ) . Studies of nonsteroidal , anti-inflammatory drugs ( NSAIDs ) exemplify how data collection methods can affect the detection and reporting of harms . When selective NSAIDs with fewer gastrointestinal adverse events became available , trials reported more than 10 times as many ulcers when comparing these drugs with older NSAIDs as when older NSAIDs were compared with placebo . In the newer trials , more ulcers were detected because participants had regular endoscopy , and the case definition of ulcers was more sensitive ( 34 ) . Authors should specify the time frame of surveillance for adverse events . Some investigators stop recording adverse events at the end of the intervention period or a certain number of days afterward ( for example , 30 days after discontinuation of drug therapy ) and miss events with long latency ( 35 ) . Surgical trials often capture only the adverse events that occur intraoperatively . Several important surgical complications are likely to occur later . Finally , in crossover trials , delayed events might occur while the patient is taking a subsequent assigned treatment . Attribution is the process of deciding whether an adverse event is related to the intervention . Whenever authors filter events through an attribution process , they should state who makes the attribution ( investigators , participants , sponsors , or combinations ) , whether the process is blinded to assigned treatment , and what definitions of adverse events they use ( 4 ) . Discontinuations and withdrawals due to adverse events are especially important because they reflect the ultimate decision of the participant and /or physician to discontinue treatment . Although treatment may occasionally be discontinued for mild or moderate adverse events , attributing discontinuation to a specific reason ( to toxicity , lack of efficacy , other reasons , or combinations of reasons ) may be difficult . For example , in psychopharmacology , dropouts may reflect treatment ineffectiveness as much as toxicity-related intolerance ( 36 ) . Trial reports should specify who gave the reasons for discontinuation ( participants or physicians ) and whether attribution was blinded to the assigned treatment . For example , even in blinded trials , participants and their clinicians are often unblinded before they decide whether to discontinue the intervention . It is important to report participants who are nonadherent or lost to follow-up because their actions may reflect their inability to tolerate the intervention . Moreover , authors should specify how they h and led withdrawals in the analyses of the data . R and omized , controlled trials should report any plan for monitoring for harms and rules for stopping the trial because of harms ( 37 ) . They should clarify whether stopping guidelines examine benefits and harms BACKGROUND Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD ( ND-CKD ) , the comparative treatment value of IV iron infusion and oral iron supplementation has not been established . METHODS In a r and omized , controlled multicenter trial , we compared the efficacy of iron sucrose , given as 1 g in divided IV doses over 14 days , with that of ferrous sulfate , given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5 , Hb < or = 11 g/dL , TSAT < or = 25 % , and ferritin < or = 300 ng/mL.  Epoetin/darbepoetin therapy , if any , was not changed for eight weeks prior to or during the study . RESULTS The proportion of patients achieving the primary outcome ( Hb increase > or = 1 g/dL ) was greater in the IV iron treatment group than in the oral iron treatment group ( 44.3 % vs. 28.0 % , P= 0.0344 ) , as was the mean increase in Hb by day 42 ( 0.7 vs. 0.4 g/dL , P= 0.0298 ) . Compared to those in the IV iron group , patients in the oral iron treatment group showed a greater decline in GFR during the study ( -4.40 vs. -1.45 mL/min/1.73m2 , P= 0.0100 ) . No serious adverse drug events ( ADE ) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes , but drug-related hypotension , including one event considered serious , occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours . CONCLUSION IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices Iron deficiency is an important cause of anemia in patients with chronic kidney disease ( CKD ) , but intravenous iron is infrequently used among patients who are not on dialysis .  Ferumoxytol is a novel intravenous iron product that can be administered as a rapid injection . This Phase III trial r and omly assigned 304 patients with CKD in a 3:1 ratio to two 510-mg doses of intravenous ferumoxytol within 5 + /- 3 d or 200 mg of elemental oral iron daily for 21 d. The increase in hemoglobin at day 35 , the primary efficacy end point , was 0.82 + /- 1.24 g/dl with ferumoxytol and 0.16 + /- 1.02 g/dl with oral iron ( P < 0.0001 ) . Among patients who were not receiving erythropoiesis-stimulating agents , hemoglobin increased 0.62 + /- 1.02 g/dl with ferumoxytol and 0.13 + /- 0.93 g/dl with oral iron . Among patients who were receiving erythropoiesis-stimulating agents , hemoglobin increased 1.16 + /- 1.49 g/dl with ferumoxytol and 0.19 + /- 1.14 g/dl with oral iron .  Treatment-related adverse events occurred in 10.6 % of patients who were treated with ferumoxytol and 24.0 % of those who were treated with oral iron ; none was serious . In summary , a regimen of two doses of 510 mg of intravenous ferumoxytol administered rapidly within 5 + /- 3 d was well tolerated and had the intended therapeutic effect . This regimen may offer a new , efficient option to treat iron deficiency anemia in patients with CKD BACKGROUND Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores . Until recently , the only available form of intravenous iron was iron dextran , which is associated with significant adverse reactions , including anaphylaxis and death . Sodium ferric gluconate complex ( SFGC ) was recently approved for use in the U.S. under FDA 's priority drug review . This Phase IV study was design ed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control . METHODS This multicenter , crossover , r and omized , double blind , placebo-controlled prospect i ve comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron . The historical control was obtained from a meta- analysis of four publications examining outcomes in patients exposed to iron dextran . SFGC naïve patients were administered SFGC without a test dose , undiluted , at a rate of 125 mg over 10 minutes , and compared to placebo comprising bacteriostatic saline . RESULTS A total of 2534 patients were enrolled . The incidence of drug intolerance ( an adverse event precluding re-exposure ) was significantly less [ 0.44 % , confidence interval ( CI ) 0.21 to 0.71 % ] after SFGC as compared to the iron dextran control ( 2.47 % , CI 1.87 to 3.07 % , P < 0.0001 ) , but higher than after placebo ( 0.1 % , P = 0.02 ) . There was no difference found between SFGC and placebo in serious adverse events . A single life-threatening event occurred after SFGC ( 0.04 % , CI 0.00 to 0.22 % ) , which was significantly less than following iron dextran ( 0.61 % , CI 0.36 to 0.86 % ) , P = 0.0001 . CONCLUSION SFGC is well tolerated when given by intravenous push without a test dose . SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran . The routine use of iron dextran in hemodialysis patients should be discontinued BACKGROUND AIMS : Anemia is a common complication of inflammatory bowel diseases ( IBD ) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation , ferric carboxymaltose ( FeCarb ) , in comparison with oral ferrous sulfate ( FeSulf ) in reducing iron deficiency anemia ( IDA ) in IBD . METHODS : Two hundred patients were r and omized in a 2:1 ratio ( 137 FeCarb:63 FeSulf ) to receive FeCarb ( maximum 1,000 mg iron per infusion ) at 1-wk intervals until the patients ' calculated total iron deficit was reached or FeSulf ( 100 mg b.i.d . ) for 12 wk . The primary end point was change in hemoglobin ( Hb ) from baseline to week 12 . RESULTS : The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group , demonstrating noninferiority ( P = 0.6967 ) . Response ( defined as Hb increase of > 2.0 g/dL ) was higher for FeCarb at week 2 ( P = 0.0051 ) and week 4 ( P = 0.0346 ) . Median ferritin increased from 5.0 to 323.5 μg/L at week 2 , followed by a continuous decrease in the FeCarb group ( 43.5 μg/L at week 12 ) . In the FeSulf group , a moderate increase from 6.5 to 28.5 μg/L at week 12 was observed . Treatment-related adverse events ( AEs ) occurred in 28.5 % of the FeCarb and 22.2 % of the FeSulf groups , with discontinuation of study medication due to AEs in 1.5 % and 7.9 % , respectively . CONCLUSIONS : FeCarb is effective and safe in  IBD-associated anemia  . It is noninferior to FeSulf in terms of Hb change over 12 wk , and provides a fast Hb increase and a sufficient refill of iron stores INTRODUCTION Anemia is the most common finding in chronic kidney disease patients .  Iron supplements are commonly prescribed for these patients with or without erythropoietin therapy by means of oral and intravenous iron . Both oral and intravenous irons have their own advantage and disadvantage , and the efficacy is also different . The objective of the study is to analyze the efficacy of oral and intravenous iron in chronic kidney disease patients on erythropoietin therapy , an erythropoiesis stimulating agents for increment of haemoglobin . METHODS This is a prospect i ve study comparing intravenous iron to oral iron in chronic kidney disease patients who underwent maintenance hemodialysis at different centers and visited Kathm and u Medical College Teaching Hospital from April 2010 to April 2011 . Patients having a haemoglobin level of < 11 g/dl , transferrin saturation ( TSAT ) < 25 % , ferritin < 300ng/ml and who were on erythropoietin therapy were allocated alternately into two groups to receive oral iron ( iron fumarate ) or IV iron ( iv sucrose ) .  Haemoglobin was measured after 30 days of therapy . RESULTS A significant increase in haemoglobin levels was observed in both groups . But the mean haemoglobin increment was more in the IV iron group than in the oral iron group . Sixty percent 60 % of patients in the IV iron group had an increase in the haemoglobin level of more than 1gm/dl while only 20 % of the oral iron group had this increase . CONCLUSIONS Intravenous iron therapy is more effective in raising the hemoglobin level in hemodialysis dependent chronic kidney disease patients OBJECTIVE Postpartum iron deficiency anaemia ( IDA ) is common in women . Most women are treated with either oral iron supplementation or blood transfusion . Hence , the aim of our study was to compare the effect of treatment with either oral ferrous sulphate or intravenous ferrous sucrose on postpartum IDA . DESIGN A single centre , prospect i ve r and omised controlled trial . SETTING Women 's Centre , John Radcliffe Hospital , Oxford , UK . POPULATION Forty-four women with haemoglobin ( Hb ) of < 9 g/dl and ferritin of < 15 microgram/l at 24 - 48 hours postdelivery . METHODS Women were r and omised to receive either oral ferrous sulphate 200 mg twice daily for 6 weeks ( group O ) or intravenous ferrous sucrose 200 mg ( Venofer ; Vifor International Ltd , St Gallen , Switzerl and ) , two doses given on days 2 and 4 following recruitment ( group I ) . RESULTS were analysed by the Students t-test , chi-square test and analysis of variance . MAIN OUTCOME MEASURES Hb , haematocrit , red cell indices , ferritin and serum iron levels were measured on days 0 , 5 , 14 and 40 . Results By day 5 , the Hb level in women treated with intravenous iron had risen from 7.3 + /- 0.9 to 9.9 + /- 0.7 g/dl , while there was no change in those treated with oral iron . Women treated with intravenous iron had significantly higher Hb levels on days 5 and 14 ( P < 0.01 ) than those treated with oral iron ; although by day 40 , there was no significant difference between the two groups . Throughout the study , ferritin levels rose rapidly in those treated with intravenous iron and remained significantly higher than in those treated with oral iron ( P < 0.01 ) . CONCLUSIONS Intravenous iron sucrose increases the Hb level more rapidly than oral ferrous sulphate in women with postpartum IDA . It also appears to replenish iron stores more rapidly . However , this study was not large enough to address the safety of this strategy Background : Iron deficiency anemia ( IDA ) is the most common medical problem in pregnancy .  Parenteral iron is a useful treatment , although iron dextran use decreased due to anaphylaxis . Iron sucrose is a newer agent that has overcome the shortcomings of iron dextran . Objective : The aim of this study was to compare the efficacy and tolerance of intravenous iron sucrose ( IVIS ) therapy with oral iron ( OI ) therapy in pregnant women with IDA and to study the factors influencing treatment . Material s and Methods : This prospect i ve , r and omized clinical trial included pregnant women between 14 and 36 weeks with established IDA who were treated with IVIS or OI ( ferrous fumarate ) .  All patients were monitored for laboratory response and adverse effects . Independent sample -t test , Chi square test and ANOVA were used for statistical analysis . P < 0.05 was considered significant . Results : Although hemoglobin increased in both the groups , increase in the reticulocyte count and percentage increase in hemoglobin was significantly higher in the IVIS group than in the OI group ( 23.62 % vs. 14.11 % ) . Serum ferritin was significantly higher in the IVIS group than in the OI group ( P = 0.000 ) . The IVIS group had no major side-effects . Compliance was good with OI , although 23 % had gastrointestinal side-effects . Patient weight , gestation at diagnosis , initial hemoglobin and ferritin levels did not influence the response to treatment . Conclusion : IVIS is safe and effective in the treatment of IDA during pregnancy . Iron stores increased better with IVIS compared with OI BACKGROUND There are concerns about adverse vascular effects of intravenous iron by inducing oxidative stress . We therefore examined the effect of a single high dose of intravenous iron on endothelial function and biochemical markers of iron homeostasis . METHODS In a r and omized , placebo-controlled , double-blind , parallel-group study , forearm blood flow ( FBF ) was assessed by strain-gauge plethysmography in 38 peritoneal dialysis patients before and after a single intravenous infusion of 300 mg iron sucrose . RESULTS Iron infusion increased total ( Delta 601 microg/100 mL , CI 507 , 696 ) and non-transferrin-bound iron ( Delta 237.2 micromol/L , CI 173.6 , 300.8 ) approximately 10-fold , as well as redox-active iron nearly five-fold ( Delta 0.76 micromol/L , CI 0.54 , 0.98 ) . After iron infusion basal FBF was 59 % higher than after placebo . FBF response to acetylcholine before and after iron infusion was 263 + /- 32 % and 310 + /- 33 % , corresponding to 304 + /- 43 % and 373 + /- 29 % in the placebo group , respectively . Before and after iron or placebo infusion , glyceryl-trinitrate increased resting FBF to 232 + /- 22 % and 258 + /- 21 % in the iron group , and to 234 + /- 18 % and 270 + /- 30 % in the placebo group . L-N-monomethyl-arginine decreased FBF to 70 + /- 4 % and 72 + /- 3 % before and after iron , and to 74 + /- 4 % and 73 + /- 4 % before and after placebo infusions , respectively . Despite higher basal FBF after iron infusion , absolute and relative FBF changes in response to vasoactive substances were not significantly different between iron and placebo groups . CONCLUSION Our data suggest that 300 mg intravenous iron sucrose has a vasodilatory effect , but does not impair vascular reactivity in dialysis patients , despite a significant increase in non-transferrin-bound and redox-active iron OBJECTIVE The aim of this study was to compare intravenous iron sucrose versus oral iron sulfate in anemia at 6 months of pregnancy . STUDY DESIGN A r and om , prospect i ve , open study with individual benefit was performed involving 50 patients with hemoglobin levels between 8 and 10 g/dL and a ferritin value of < 50 microg/L. In the intravenous group ( IV group ) , the iron dose was calculated from the following formula : Weight before pregnancy ( kg ) x ( 120 g/L - Actual hemoglobin [ g/L ] ) x 0.24 + 500 mg . The oral group ( PO group ) received 240 mg of iron sulfate per day for 4 weeks . Treatment efficacy was assessed by measurement of hemoglobin and reticulocytes on days 8 , 15 , 21 , and 30 and at delivery and of ferritin on day 30 and at delivery . The baby 's birth weight and iron stores were noted . Results were expressed as median + /- interquartile range . Mann-Whitney and Wilcoxon tests were used for the analysis , with P < .05 considered significant . RESULTS An increase in hemoglobin was observed , rising from 9.6 + /- 0.79 g/dL to 11.11 + /- 1.3 g/dL on day 30 in the IV group and from 9.7 + /- 0.5 g/dL to 11 + /- 1.25 g/dL on day 30 in the PO group ( not significant ) . On day 30 ( P < .0001 ) and at delivery ( P = .01 ) ferritin was higher in the IV group . A mean higher birth weight of 250 g was noted in the IV group ( not significant ) . CONCLUSION Iron sucrose appears to be a treatment without serious side effects indicated in correction of pregnancy anemia or iron stores depletion BACKGROUND Iron deficiency anemia is a common complication in patients with chronic kidney disease ( CKD ) . Currently available intravenous ( IV ) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting .  Ferumoxytol is a novel , semisynthetic , carbohydrate-coated , superparamagnetic iron oxide nanoparticle that is administered IV as an injection . The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D . STUDY DESIGN Phase 3 , r and omized , double-blind , placebo-controlled , crossover , multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo . SETTING & PARTICIPANTS 750 patients with CKD stages 1 to 5 and 5D . INTERVENTION An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7 . OUTCOMES & MEASUREMENTS Descriptive comparison of adverse events , laboratory tests , and vital signs . RESULTS Of 750 r and omly assigned patients with CKD , 60 % were not on dialysis therapy . 713 patients received ferumoxytol , and 711 received placebo .  There were 420 adverse events reported ; 242 in 152 patients ( 21.3 % ) with ferumoxytol and 178 in 119 patients ( 16.7 % ) with placebo .  The incidence of related adverse events was 5.2 % with ferumoxytol and 4.5 % with placebo . The most common related adverse events after each treatment included symptoms related to the injection/infusion site , dizziness , pruritus , headache , fatigue , and nausea . Serious adverse events occurred in 21 patients ( 2.9 % ) after ferumoxytol and 13 patients ( 1.8 % ) after placebo .  Serious related adverse events were observed in 1 patient ( 0.1 % ) after each treatment . There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo . LIMITATIONS Follow-up was 7 days after each study treatment . CONCLUSIONS Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemic patients with CKD stages 1 to 5 and 5D OBJECTIVE To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women . STUDY DESIGN 260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were r and omised between the 21st and 24th week into either the intravenous iron group or the oral iron group . Of 130 women in the intravenous iron group , 75 women received two doses of 200 mg iron sucrose and 55 three doses of 200 mg iron sucrose . The first dose was administered between the 21st and 24th gestational weeks , the second between the 28th and 32nd and the third between the 35th and 37th . The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily , beginning on the day of study enrolment and stopping on the day of delivery . RESULTS There was a non-significant trend to a higher frequency of responders ( haemoglobin > or = 11 g/dl ) in the intravenous iron group ( 75 vs. 80 % ) . There was a significant difference of repleted iron stores before delivery ( ferritin>50 microg/l ) in the group with three intravenous iron doses in comparison to the oral iron group ( 49 vs. 14 % ; p<0.001 ) . No differences were observed in regard to maternal and perinatal outcomes . CONCLUSIONS There was no clinical ly significant difference in the haematological , maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women BACKGROUND & AIMS Iron-deficiency anemia is the most common systemic complication of inflammatory bowel diseases ( IBD ) . Iron-deficiency anemia recurs frequently and rapidly after iron-replacement therapy in patients with IBD . We performed a r and omized , placebo-controlled trial to determine if administration of ferric carboxymaltose ( FCM ) prevents anemia in patients with IBD and low levels of serum ferritin . METHODS We performed a single-blind , multicenter study of nonanemic patients who had completed the FERGIcor study .  Serum levels of ferritin were assessed every second month , and patients were given FCM ( total iron dose , 1181 ± 662 mg ; n = 105 ) or placebo ( n = 99 ) when levels decreased to less than 100 μg/L. The primary end point was time to recurrence of anemia within 8 months . Secondary end points included changes of quality of life , disease activity , results from laboratory tests , and adverse events . RESULTS Anemia recurred in 26.7 % of subjects given FCM and in 39.4 % given placebo . The time to anemia recurrence was longer in the FCM group ( hazard ratio , 0.62 ; 95 % confidence interval , 0.38 - 1.00 ; P = .049 ) . Markers of body levels of iron increased or remained at normal levels in subjects given FCM ( ferritin increased by 30.3 μg/L , transferrin saturation increased by 0.6 % ) but decreased in the group given placebo ( ferritin decreased by 36.1 μg/L , transferrin saturation decreased by 4.0 % ) . Changes in quality of life and disease activity were comparable between groups . Adverse events were reported in 59.0 % of the FCM group and 50.5 % of the placebo group , and serious adverse events were reported in 6.7 % and 8.1 % , respectively . CONCLUSIONS FCM prevents recurrence of anemia in patients with IBD , compared with placebo . Nevertheless , the high rate of anemia recurrence warrants optimization of the frequency and requirements for FCM treatment PURPOSE Recombinant human erythropoietin ( rHuEPO ) is the st and ard of care for patients with chemotherapy-related anemia .  Intravenous ( IV ) iron improves hemoglobin ( Hb ) response and decreases dosage requirements in patients with anemia of kidney disease , but its effect has not been studied in r and omized trials in cancer patients . METHODS This prospect i ve , multicenter , open-label , r and omized trial enrolled 157 patients with chemotherapy-related anemia ( Hb < or= 105 g/L , serum ferritin < or= 450 pmol/L or < or= 675 pmol/L with transferrin saturation < or= 19 % ) receiving subcutaneously rHuEPO 40000 U once weekly to : ( 1 ) . no-iron ;  ( 2 )  . oral iron 325 mg twice  daily  ; ( 3 )  iron dextran repeated 100 mg IV bolus ; or ( 4 ) iron dextran total dose infusion ( TDI ) . Hb and quality of life ( QOL ) were measured at baseline and throughout . RESULTS All groups showed Hb ( P < .0001 ) increases from baseline . Mean Hb increases for both IV iron groups were greater ( P < .02 ) than for no-iron and oral iron groups . The percentage of patients with hematopoietic responses was higher ( P < .01 ) in both IV iron groups ( each case 68 % ) compared with no-iron ( 25 % ) and oral iron ( 36 % ) groups . IV iron groups showed increases in energy , activity , and overall QOL from baseline , compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group . CONCLUSION rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia . Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added BACKGROUND Preoperative treatment with rHuEPO ( epoetin alfa : EPREX , Janssen-Cilag ; or PROCRIT , Ortho Biotech ) in conjunction with iron supplementation increases the erythropoietic response in elective orthopedic surgery patients , but it is not known whether the magnitude of this response is dependent on the route of iron administration . STUDY DESIGN AND METHODS Non-iron-deficient patients undergoing elective orthopedic surgery ( N = 110 ) with baseline Hb > or = 10 to < or = 13 g per dL were r and omly assigned to receive either epoetin alfa ( 600 IU/kg ) plus IV iron ( n = 29 ) or oral iron ( n = 29 ) or placebo plus IV iron ( n = 25 ) or oral iron ( n = 27 ) in this 14-day study . RBC production , Hb , Hct , reticulocytes , iron status , and adverse events were monitored throughout the study . RESULTS Epoetin alfa treatment plus either oral or IV iron supplementation significantly increased total RBC production , Hb , Hct , and reticulocytes over the values seen with the respective placebo treatments ( p = 0.0001 ) . There were no differences between the epoetin alfa treatment groups . Placebo treatment plus oral or IV iron supplementation was not associated with increases in hematologic values . There were no differences in the incidence of adverse events among the treatment groups . CONCLUSION There was a comparable erythropoietic response to epoetin alfa , irrespective of the route of iron administration . The route of iron administration , therefore , does not modulate the erythropoietic response to epoetin alfa in patients who are not iron deficient . Safety and convenience benefits may be gained by adopting oral iron supplementation in this patient subset Objective : To compare the efficacy and safety with a fixed dose of two parenteral iron preparations , iron sucrose complex and iron sorbitol citric acid as per the current practice . Material s and Methods : A prospect i ve r and omized open label study was conducted . In this study , 60 pregnant women with hemoglobin less than 8.5 g/dl received a fixed dose of either IV iron sucrose or IM iron sorbitol citric acid therapy . The efficacy of the therapy was assessed by laboratory parameters such as hemoglobin , hematocrit , MCV , MCH , and serum ferritin level after 14 and 28 days . To assess the safety , adverse drug reactions with both the therapies were recorded . Results : Hemoglobin concentration increased significantly ( P < 0.001 ) with respect to time in both the groups . The rise in the hemoglobin level in third and fourth weeks was significantly higher in iron sucrose ( 0.92 g/dl ) than iron sorbitol citric acid therapy ( 0.56 g/dl ) . There was no significant change in the rise of the serum ferritin level after both the therapies . Adverse events were common with iron sorbitol citric acid therapy . However , no serious adverse drug reactions were observed . Conclusions : No significant difference in the efficacy of both of the therapy . However , adverse events and dropout rates were much more common in the group of pregnant women who received iron sorbitol citric acid OBJECTIVE : To estimate efficacy of rapid , large-dose intravenous ( IV ) administration of ferric carboxymaltose compared with oral iron therapy in anemic postpartum women . METHODS : In a r and omized , controlled trial , we assigned anemic women ( hemoglobin [ Hb ] less than or equal to 10 g/dL ) within 10 days postpartum to receive either IV ferric carboxymaltose ( less than or equal to1,000 mg over 15 minutes , repeated weekly to achieve a total calculated replacement dose ) or ferrous sulfate ( FeSO4 ) 325 mg orally thrice daily for 6 weeks . RESULTS : One hundred seventy-four patients received 350 IV doses of ferric carboxymaltose ( mean total dose 1,403.1 mg ) in 3 , 2 , or 1 injection ( 10.9 % , 79.3 % , or 9.8 % of patients , respectively ) ; 178 received FeSO4 . Patients assigned to IV ferric carboxymaltose compared with those assigned to oral iron achieved a Hb rise greater than or equal to 2.0 g/dL earlier ( 7.0 compared with 14.0 days , P<.001 ) , were more likely to achieve a Hb rise greater than or equal to 3.0 g/dL at any time ( 86.3 % compared with 60.4 % , P<.001 ) , and were more likely to achieve a Hb greater than 12.0 g/dL ( 90.5 % compared with 68.6 % , P<.001 ) . A similar proportion of patients achieved a Hb rise greater than or equal to 2.0 g/dL ( 96.4 % compared with 94.1 % , IV compared with oral , P=.443 ) . There were no serious adverse drug reactions . CONCLUSION : Large-dose IV ferric carboxymaltose administration is a new iron agent that is effective for the treatment of postpartum anemia . When compared with oral ferrous sulfate , IV ferric carboxymaltose is better tolerated , prompts a more rapid Hb response , and corrects anemia more reliably . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00396292 LEVEL OF EVIDENCE : The development of secondary anaemia is a constant associated phenomenon of chronic renal failure . During its treatment by recombinant human erythropoietin ( rHuEPO ) erythropoiesis is accelerated and this increases dem and s on the supply of dietary erythropoietic precursors ( Fe , pyridoxine , folic acid , vitamin B12 ) . In particular as regards iron , frequently the dietary amount is not sufficient and supplementation is necessary . The objective of the present work is to compare oral and intravenous iron supplementation in the treatment of secondary anaemia by rHuEPO in patients with chronic renal failure treated by haemodialysis . A group of haemodialyzed patients ( n = 61 ) treated with erythropoietin , where the serum ferritin concentration had dropped beneath 300 ng/ml , or the transferrin concentration below 0.20 was divided at r and om into two sub-groups . To group " A " Actiferrin was administered 3 x 1 cps/d ( Ferrosi sulfas heptahydricus , corresponding to 34.5 mg elemental Fe and serine 129 mg per capsule , i.e. a total of 724.5 mg elemental Fe per week ) . To group " A " Ferrum-Lek was administered 1 vial per week by the i.v . route ( Ferri oxidum saccharatum , corresponding to 100 mg elemental iron per week ) . The two groups were comparable as to the mean erythropoietin dose ( 50 U/kg per week ) and the patients ' mean age ( 61 years ) , the male/female ratio and the spectrum of basic diseases . After six weeks of treatment a comparable increase of the haematocrit and serum iron concentration was observed in both groups . As to transferrin saturation , there was a more marked increment in the intravenously supplemented group . The serum ferritin values in group " A " declined , while in group " F " they increased . After both types of iron supplementation a comparable increase of the haematocrit and serum iron concentration occurred , the iron reserves represented by serum ferritin differed however and from the long-term aspect they are in favour of intravenous iron supplementation in haemodialyzed patients treated with erythropoietin OBJECTIVE To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose . METHODS One hundred and ninety-four patients on maintenance dialysis with the hemoglobin ( Hb ) level of 60 - 100 g/L and hematocrit ( Hct ) of 18 % - 30 % were r and omly divided into 2 sex , age , duration of dialysis , weekly erythropoietin dosage , and hematological parameters-matched groups : intravenous iron sucrose group ( n = 102 ) and oral medication group ( n = 92 ) . The intravenous iron sucrose group were sub-divided into 2 subgroups : ( 1 )  hemodialysis  ( HD ) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks , and ( 2 )  peritoneal dialysis ( PD ) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks . The oral medication group received ferrous succinate 200 mg tid for 12 weeks . The levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , Hb , and Hct were examined before treatment and 4 , 8 , and 12 weeks after treatment . RESULTS ( 1 ) Compared with baseline levels , the levels of Hb , Hct , SF , and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group , and 4 weeks after treatment in the oral medication group ( all P < 0.05 ) . ( 2 ) The Hb , Hct , SF , and TSAT levels 4 , 6 , 8 , and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group ( all P < 0.05 ) . ( 3 ) The Hb , Hct , SF , and TSAT levels 12 weeks after treatment 6 , 8 , and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group ( all P > 0.05 ) . ( 4 ) The response rate of the intravenous iron sucrose group was 95.09 % , significantly higher than that of the oral medication group ( 55.44 % , P < 0.05 ) . ( 5 ) The mean EPO doses 6 , 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group ( all P < 0.05 ) . ( 6 ) The Hb , Hct , SF , and TSAT levels maintained stable during the period 6 , 8 , and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency . ( 7 ) The Hb , Hct , SF , and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup . ( 8) No adverse event was found in the intravenous iron sucrose group , and adverse gastrointestinal effects occurred in 12 patients of the oral medication group . ( 9 ) After 12 weeks , the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate . CONCLUSION Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated . Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO . However , the total cost of intravenous iron treatment is relatively high Purpose To determine if early recovery from  severe postoperative anemia  is accelerated byiv iron therapy alone or in combination with recombinant erythropoietin ( EPO ) . Methods In this double-blinded , placebo-controlled  r and omized study , consenting adult patients without preoperative anemia whose hemoglobin concentration ( Hb ) was 70 to 90 g·L-1 on the first day after cardiac or orthopedic surgery ( POD 1 ) were assigned to one of three groups : control , iv iron alone ( 200 mg of iron sucrose on POD 1 , 2 , and 3 ) or in combination with EPO ( 600 U·kg-1 on POD 1 and 3 ) . The primary outcome was increase in Hb ( adjusted for red blood cell transfusions ) from POD 1 to 7 . Analysis was by intention-to-treat in patients for whom the primary outcome was available . Group effect was analyzed by the ANOVA test , and between-group differences were specified with a Duncan multiple-range test . Results The primary outcome was available in 31 of 38 r and omized patients . The average POD 1 Hb was 84 ± 4 g·L-1 . There were no between-group differences in outcomes except for higher reticulocyte counts on POD-7 in the combination group . The average adjusted one-week increases in Hb were 7 ± 8 g·L-1 in the control group ( n = 10 ) , 9 ± 9 g·L-1 in theiv iron group ( n = 11 ) , and 10 ± 14 g·L-1 in the combination group ( n = 10 ) . The average adjusted six-week increases in Hb were 37 ± 14 g·L-1 in the control group , 40 ± 7 g·L-1 in theiv iron group , and 45 ± 12 g·L-1 in the combination group . Conclusion Early postoperative treatment withiv iron alone or in combination with EPO does not appear to accelerate early recovery from postoperative anemia . RésuméObjectifVérifier si la récupération précoce ďune sévère anémie postopératoire est accélérée par le fer iv seul ou en combinaison avec de ľérythropoÏétine recombinante (EPO).MéthodePour ľétude à double insu , r and omisée et contrôlée contre placebo , des adultes sans anémie préopératoire , chez qui la concentration ďhémoglobine ( Hb ) était de 70 à 90 g·L-1 au premier jour post-opération cardiaque ou orthopédique ( JPO 1 ) , ont été assignés à ľun des trois groupes : témoin , fer iv seul ( 200 mg de sucrose ferreux aux JPO 1 , 2 et 3 ) ou en combinaison avec de ľEPO ( 600 U·kg-1 aux JPO POD 1 et 3 ) . Le résultat principal était une hausse de ľHb ( ajustée pour les transfusions de culots globulaires ) des JPO 1 à 7 . Ľévaluation , pour les patients ayant atteint ce résultat , utilisait ľanalyse par intention de traiter . Ľeffet de groupe a été analysé par le test ANOVA test et les différences intergroupes ont été précisées avec le test à gamme multiple de Duncan . RésultatsLe résultat principal était atteint chez 31 des 38 patients r and omisés .  La moyenne de ľHb au JPO 1 a été de 84 ± 4 g·L-1 . Il n’y a pas eu de différence de résultat intergroupe sauf pour une numération plus élevée des réticulocytes au JPO 7 dans le groupe ďEPO . Les hausses moyennes ďHb ajustées sur une semaine ont été de 7 ± 8 g·L-1dans le groupe témoin ( n = 10 ) , 9 ± 9 g·L-1 avec le fer iv ( n = 11 ) et 10 ± 14 g·L-1 avec ľEPO ( n = 10 ) . Les hausses moyennes ďHb ajustées sur six semaines ont été de 37 ± 14 g·L-1 chez les témoins , 40 ± 7 g·L-1 avec le fer iv et 45 ± 12 g·L-1 avec ľEPO . Conclusion Le traitement postopératoire précoce avec du fer iv seul ou en combinaison avec ľEPO ne semble pas hâter la récupération de ľanémie postopératoire Background : It is unknown whether intravenous iron or oral iron repletion alone can correct anemia associated with chronic kidney disease ( CKD ) . We conducted a r and omized multicenter controlled trial in adult anemic , iron-deficient non-dialysis CKD ( ND-CKD ) patients ( ≧stage 3 ) not receiving erythropoiesis-stimulating agents ( ESAs ) . Methods : The participants were r and omized to receive either a sodium ferric gluconate complex ( intravenous iron ) 250 mg i.v . weekly × 4 or ferrous sulfate ( oral iron ) 325 mg t.i.d . × 42 days . Hemoglobin ( Hgb ) , ferritin and transferrin saturation ( TSAT ) were measured serially , and the Kidney Disease Quality of Life ( KDQoL ) question naire was administered on days 1 and 43 . The primary outcome variable was change from baseline ( CFB ) to endpoint in Hgb values . Results : Seventy-five patients were analyzed  ( intravenous iron n = 36 , oral iron n = 39 ) . CFB in Hgb was similar in the two groups ( intravenous iron 0.4 g/dl vs. oral iron 0.2 g/dl , p = n.s . ) . However , the increase in Hgb was only significant with intravenous iron ( p < 0.01 ) . In comparison to oral iron , intravenous iron achieved greater improvements in ferritin ( 232.0 ± 160.8 vs. 55.9 ± 236.2 ng/ml , p < 0.001 ) and TSAT ( 8.3 ± 7.5 vs. 2.9 ± 8.8 % , p = 0.007 ) . Intravenous iron caused greater improvements in KDQoL scores than oral iron ( p < 0.05 ) . The most common side effect reported with intravenous iron was hypotension , while constipation was more common with oral iron . Conclusions : Oral and intravenous iron similarly increase Hgb  in anemic iron-depleted ND-CKD patients not receiving ESAs . Although in comparison to oral iron , intravenous iron may result in a more rapid repletion of iron stores and greater improvement in quality of life , it exposes the patients to a greater risk of adverse effects and increases inconvenience and cost OBJECTIVE Intravenous ( IV ) iron has been used as a treatment to reduce Restless Legs Syndrome ( RLS ) symptoms , but two double-blinded trials of a frequently prescribed IV iron formulation , iron sucrose , failed to show lasting efficacy . This study evaluates efficacy and safety of a new IV iron formulation ( ferric carboxymaltose , FCM ) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does . METHODS In this 28-day , multi-centre , r and omised , placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment . Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo . At day 28 , those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM . Patients were followed up for 24 weeks or until needing added RLS treatment . RESULTS FCM significantly improved primary and secondary outcomes compared to placebo :  International Restless Legs Syndrome study group severity scale ( IRLS ) average ( SD ) decrease of 8.9 ( 8.52 ) versus 4.0 ( 6.11 ) , p=0.040 ; Clinical Global Inventory of Change ( CGI-1 ) very much or much improved 48.3 % versus 14.3 % , p=0.004 . Quality of life was also significantly improved . Of the 24 with initial iron treatment 45 % responded and 29 % remitted ( IRLS ≤ 10 ) at day 28 , and 25 % continued free of other RLS medications at 24 weeks after treatment . The single 1000 mg dose on day 28 produced the same degree of treatment response as the divided dose , but the added 500 mg dose for those not responding to the initial treatment showed little benefit . There were no significant adverse events . CONCLUSIONS IV FCM  provided a safe and effective treatment for RLS that lasted for at least 24 weeks for some patients . Larger studies are needed to confirm these results BACKGROUND AND OBJECTIVES Intravenous iron is a key component of anemia management for chronic kidney disease ( CKD ) .  Ferumoxytol is a unique intravenous iron product that can be administered as a rapid injection in doses up to 510 mg . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS This was a r and omized , open-label , controlled , multicenter Phase 3 trial to evaluate the safety and efficacy of intravenous ferumoxytol compared with oral iron .  Anemic patients with CKD stage 5D on hemodialysis and on a stable erythropoiesis-stimulating agent regimen received either two injections of 510 mg of ferumoxytol within 7 d ( n = 114 ) or 200 mg elemental oral iron daily for 21 d ( n = 116 ) . The primary efficacy endpoint was the change in hemoglobin from baseline to day 35 . Safety was closely monitored . RESULTS Ferumoxytol result ed in a mean increase in hemoglobin of 1.02 + /- 1.13 g/dl at day 35 compared with 0.46 + /- 1.06 g/dl with oral iron ( P = 0.0002 ) . Twice as many ferumoxytol-treated patients than oral iron-treated patients achieved a > or = 1 g/dl hemoglobin increase at day 35 ( P = 0.0002 ) . There was a greater mean increase in transferrin saturation ( TSAT ) with ferumoxytol compared with oral iron at day 35 ( P < 0.0001 ) . The larger hemoglobin increase after ferumoxytol compared with oral iron at day 35 persisted after adjustment for baseline hemoglobin , TSAT , and serum ferritin . Overall adverse event rates were comparable between groups . CONCLUSIONS In patients on hemodialysis , rapid intravenous injection of 510 mg of ferumoxytol led to significantly greater hemoglobin increases compared with oral iron , with comparable tolerability OBJECTIVES To compare oral versus intravenous iron in pre-dialysis patients of chronic renal failure ( CRF ) receiving recombinant human erythropoietin ( rHuEPO ) . METHODS The study was undertaken in 40 adult patients of chronic renal failure . The patients were r and omly divided into two groups A and B of 20 patients each . Group A patients were given oral iron and group B patients were given intravenous iron . All patients in both groups were given recombinant human erythropoietin 2000 IU twice weekly subcutaneously . The study was carried for up to three months . Patients were monitored every month for renal parameters and haematological parameters which included haemoglobin , reticulocyte count and packed cell volume . Ferrokinetic studies were done at baseline and at three months . RESULTS It was observed that haematological parameters showed significant statistical improvement in the intravenous iron group as compared to group A ( oral iron group ) . The ferrokinetic studies revealed that serum iron , serum ferritin and transferrin saturation , decreased significantly in oral iron group , whereas significant increase was seen in group B ( intravenous iron group ) . None of the patients developed any adverse effects because of erythropoietin or iron therapy . CONCLUSIONS Concomitant use of intravenous iron is better than oral iron in CRF patients treated with rHuEPO . The intravenous route of iron administration may be a preferred route along with rHuEPO therapy , more so in the Indian context where prevalence of iron deficiency anaemia is fairly high BACKGROUND The main objective of this study was to determine the efficacy of intravenous ( IV ) iron sucrose therapy reducing transfusion requirements in elderly patients undergoing hip fracture surgery . STUDY DESIGN AND METHODS This study was a prospect i ve r and omized controlled trial involving 200 patients undergoing hip fracture surgery . Group A ( 100 patients ) received st and ard treatment , while Group B ( 100 patients ) received iron sucrose ( 600 mg IV ) . The primary endpoint was the number of patients that were transfused postoperatively . The secondary endpoints were the rate of red blood cell units used , hematimetric variables of blood tests , mortality , infection rates , length of hospital stay , and appearance of side effects . RESULTS Differences in the percentage of patients requiring transfusion ( Group A 41.3 % vs. Group B 33.3 % ) and in the number of concentrates transfused ( 0.87±1.21 for Group A vs. 0.76±1.16 for Group B ) were not significant for the patient group as a whole , but were significant for patients with intracapsular fractures ( 45.7 % required transfusion in Group A vs. 14.3 % in Group B ; p<0.005 ) and in patients with a baseline hemoglobin ( Hb ) level of 12 g/dL or more ( 35.2 % required transfusions in Group A vs. 19 % in Group B ; p<0.05 ) . CONCLUSIONS Transfusion requirements in patients with intracapsular fracture or baseline Hb level of 12 g/dL or more appear to be reduced by IV iron sucrose therapy , but there was no difference in morbidity , mortality , or length of hospital stay . The treatment is safe and hastens recovery from blood loss BACKGROUND Anemia in heart failure patients and has been associated with increased morbi-mortality . Previous studies have treated anemia in heart failure patients with either erythropoietin alone or combination of erythropoietin and intravenous ( i.v . ) iron . However , the effect of i.v . or oral ( p.o . ) iron supplementation alone in heart failure patients with anemia was virtually unknown . AIM To compare , in a double-blind design , the effects of i.v . iron versus p.o . iron in anemic heart failure patients . METHODS IRON-HF study was a multicenter , investigator initiated , r and omized , double-blind , placebo controlled trial that enrolled anemic heart failure patients with preserved renal function , low transferrin saturation ( TSat ) and low-to-moderately elevated ferritin levels . Interventions were Iron Sucrose i.v . 200 mg , once a week , for 5 weeks , ferrous sulfate 200 mg p.o . TID , for 8 weeks , or placebo . Primary endpoint was variation of peak oxygen consumption ( peak VO2 ) assessed by ergospirometry over 3 month follow-up . RESULTS Eighteen patients had full follow-up data . There was an increment of 3.5 ml/kg/min in peak VO2 in the i.v . iron group . There was no increment in peak VO2 in the p.o . iron group . Patients ' ferritin and TSat increased significantly in both treated groups . Hemoglobin increased similarly in all groups . CONCLUSION I.v . iron seems to be superior in improving functional capacity  of heart failure patients . However , correction of anemia seems to be at least similar between p.o . iron and i.v . iron supplementation OBJECTIVE The objective of the study was to evaluate the efficacy , safety , and tolerability of intravenous ferric carboxymaltose , compared with oral ferrous sulfate in women with postpartum anemia . STUDY DESIGN In a multicenter , r and omized , controlled study , 291 women less than 10 days after delivery with hemoglobin 10 g/dL or less were r and omized to receive ferric carboxymaltose ( n = 143 ) 1000 mg or less intravenously over 15 minutes or less , repeated weekly to a calculated replacement dose ( maximum 2500 mg ) or ferrous sulfate ( n = 148 ) 325 mg orally thrice daily for 6 weeks . RESULTS Ferric carboxymaltose-treated subjects were significantly more likely to : ( 1 ) achieve a hemoglobin greater than 12 g/dL in a shorter time period with a sustained hemoglobin greater than 12 g/dL at day 42 , ( 2 ) achieve hemoglobin rise 3 g/dL or greater more quickly , and ( 3 ) attain higher serum transferrin saturation and ferritin levels . Drug-related adverse events occurred less frequently with ferric carboxymaltose . CONCLUSION Intravenous ferric carboxymaltose was safe and well tolerated with an efficacy superior to oral ferrous sulfate in the treatment of postpartum iron deficiency anemia BACKGROUND Iron deficiency anaemia is the most common deficiency disorder in the world , affecting more than one billion people , with pregnant women at particular risk . OBJECTIVES AND DESIGN We conducted a single site , prospect i ve , nonblinded r and omized-controlled trial to compare the efficacy , safety , tolerability and compliance of st and ard oral daily iron versus intravenous iron . SUBJECTS We prospect ively screened 2654 pregnant women between March 2007 and January 2009 with a full blood count and iron studies , of which 461 ( 18 % ) had moderate IDA . Two hundred women matched for haemoglobin concentration and serum ferritin level were recruited . INTERVENTIONS Patients were r and omized to daily oral ferrous sulphate 250 mg ( elemental iron 80 mg ) with or without a single intravenous iron polymaltose infusion . RESULTS Prior to delivery , the intravenous plus oral iron arm was superior to the oral iron only arm as measured by the increase in haemoglobin level ( mean of 19.5 g/L vs. 12 g/L ; P < 0.001 ) ; the increase in mean serum ferritin level ( 222 microg/L vs. 18 ug/L ; P < 0.001 ) ; and the percentage of mothers with ferritin levels below 30 microg/L ( 4.5 % vs. 79 % ; P < 0.001 ) . A single dose of intravenous iron polymaltose was well tolerated without significant side effects . CONCLUSIONS Our data indicate that intravenous iron polymaltose is safe and leads to improved efficacy and iron stores compared to oral iron alone in pregnancy-related IDA BACKGROUND Correction of anaemia as a result of renal failure improves cardiovascular function and also provides significant cognitive and emotional benefits . The most appropriate route for iron supplementation has not been determined for patients with chronic renal failure who are not yet on dialysis . METHODS Forty-five anaemic patients with progressive renal insufficiency ( PRI ) were prospect ively r and omized to receive oral ( ferrous sulphate 200 mg tds ) or intravenous ( 300 mg iron sucrose monthly ) iron treatment . Erythropoietin ( rHuEpo ) was simultaneously commenced and the dose adjusted according to a pre-established protocol . RESULTS There were no significant differences in baseline patient characteristics between the two groups . The average follow-up was 5.2 months . Three patients suffered possible allergic reactions to iron sucrose . Haemoglobin response and changes in red cell hypochromasia were similar in the two groups , but serum ferritin was significantly higher in the intravenous group . The starting dose of rHuEpo could be temporarily discontinued in 43 % of patients on oral iron and 33 % of patients receiving iron sucrose ( NS ) . rHuEpo was increased after 3 months in 9 % of patients on oral iron and 19 % of patients receiving iron sucrose ( NS ) . Final doses of rHuEpo were 33.5 ( 0 - 66 ) and 41.6 ( 0 - 124 ) U/kg/week respectively in the oral and intravenous groups ( NS ) . Although gastro-intestinal symptoms were more commonly reported in patients taking oral iron , these were mild according to scores on visual analogue scales . Dietary protein and energy intake were not significantly different in the two groups at 0 , 3 and 6 months . CONCLUSIONS In pre-dialysis patients , the efficacy of monthly 300 mg iron sucrose given intravenously is not superior with regard to haemoglobin response and rHuEpo dose as compared with a daily oral dose of 600 mg of ferrous sulphate or equivalent . Where intravenous iron is preferred , lower doses may help to reduce the incidence of allergic or " free iron " reactions , especially in patients with low body mass BACKGROUND The objective was to evaluate efficacy and safety of rapid , large-dose intravenous ( IV ) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding . STUDY DESIGN AND METHODS In a r and omized , controlled trial , 477 women with anemia , iron deficiency , and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose ( < or=1000 mg over 15 min , repeated weekly to achieve a total calculated replacement dose ) or 325 mg of ferrous sulfate ( 65 mg elemental iron ) prescribed orally thrice daily for 6 weeks . RESULTS Compared to those assigned to ferrous sulfate , more patients assigned to ferric carboxymaltose responded with a hemoglobin ( Hb ) increase of 2.0 g/dL or more ( 82 % vs. 62 % , 95 % confidence interval for treatment difference 12.2 - 28.3 , p < 0.001 ) , more achieved a 3.0 g/dL or more increase ( 53 % vs. 36 % , p < 0.001 ) , and more achieved correction ( Hb > or= 12 g/dL ) of anemia ( 73 % vs. 50 % , p < 0.001 ) . Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue ( p < 0.05 ) . There were no serious adverse drug events . CONCLUSIONS In patients with iron deficiency anemia due to heavy uterine bleeding , rapid IV administration of large doses of a new iron agent , ferric carboxymaltose , is more effective than oral iron therapy in correcting anemia , replenishing iron stores , and improving quality of life Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome ( RLS ) . We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit . Sixty patients with primary RLS ( seven males , age 46 ( 9 ) years , S-ferritin < or = 45 microg/L ) recruited from a cohort of 231 patients were r and omly assigned in a 12-months double-blind , multi-centre study of iron sucrose 1000 mg ( n = 29 ) or saline ( n = 31 ) . The primary efficacy variable was the RLS severity scale ( IRLS ) score at week 11 . Median IRLS score decreased from 24 to 7 ( week 11 ) after iron sucrose and from 26 to 17 after placebo ( P = 0.123 , N.S. for between treatment comparison ) . The corresponding scores at week 7 were 12 and 20 in the two groups ( P = 0.017 ) . Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose ( Kaplan-Meier estimate , log rank test P = 0.0006 ) suggesting an iron induced superior long term RLS symptom control . Iron sucrose was well tolerated . This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase ( 7 weeks ) and during long-term follow up in patients with variable degree of iron deficiency . Further studies on target patient groups , dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS Abstract : Anaemia is the most common medical disorder in pregnancy with iron deficiency anaemia accounting for the majority of cases . Over 90 % of the iron deficiency anaemia is due to red cell iron deficiency associated with depleted iron stores and deficient intake . The two main modalities of treating iron deficiency anaemia are oral or parenteral iron . Ferrous Hausmann ® ( iron dextrin ) is the latest iron preparation which can be used for intravenous parenteral administration as a total dose infusion . This study compares the efficacy of Ferrum Hausmann ® with oral ferrous fumarate therapy in the treatment of iron deficiency anaemia in pregnancy . Our study shows that treatment with intravenous Ferrum Hausmann ® ( iron dextrin ) result ed in a significantly better level and rate of increase of haemoglobin ( p<0.001 ) . Serum ferritin , which is the best indicator of iron stores , was significantly higher ( p<0.001 ) in the intravenous group . Other indices of iron status such as serum iron , serum transferrin and zinc protoporphyrin also showed a significant improvement in the intravenous group compared to those given oral iron . The results suggest that intravenous iron as a total dose infusion is able to replenish iron stores more efficiently , completely and at a faster rate than oral iron therapy , thus providing the fuel for stimulation of full erythopoiesis compared to oral iron . There were also no reports of any adverse reactions with intravenous iron dextrin , whereas there were a considerable proportion of women on oral iron therapy who reported side effects . In conclusion , intravenous iron therapy with Ferrous Hausmann ® ( iron dextrin ) is a suitable , effective and safe alternative to oral iron therapy in the treatment of iron deficiency anaemia in pregnancy OBJECTIVE The incidence of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy is estimated to be more than 50 % . Transfusion has been the mainstay of hematologic support with its inherent hazards including infection and transfusion reaction . The aim of this study was to examine the impact of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients undergoing concurrent chemoradiotherapy . METHODS From Oct. 2003 to Dec. 2005 , 75 patients were treated with platinum-based concurrent chemoradiotherapy .  Thirty patients received 200 mg of iron sucrose intravenously ( study group ) and 45 patients did not receive it ( control group ) . RESULTS In the study group , only 12 ( 40.0 % ) patients required blood transfusions , whereas 29 ( 64.0 % ) patients in the control group needed blood transfusions ( P=0.04 ) . Mean transfusion units were 1.87 units in the study group and 3.58 units in the control group ( P=0.04 ) . CONCLUSION This study showed that intravenous supply of iron sucrose could decrease transfusion requirement and increase serum hemoglobin level in patients with cervical carcinoma undergoing concurrent chemoradiotherapy . Therefore , intravenously administered iron sucrose would be effective in the prevention of anemia of cervical cancer patients receiving concurrent chemoradiotherapy Few data exist to guide treatment of anemic hemodialysis patients with high ferritin and low transferrin saturation ( TSAT ) . The Dialysis Patients ' Response to IV Iron with Elevated Ferritin ( DRIVE ) trial was design ed to evaluate the efficacy of intravenous ferric gluconate in such patients . Inclusion criteria were hemoglobin < or=11 g/dl , ferritin 500 to 1200 ng/ml , TSAT < or=25 % , and epoetin dosage > or=225 IU/kg per wk or > or=22,500 IU/wk . Patients with known infections or recent significant blood loss were excluded . Participants ( n=134 ) were r and omly assigned to no iron ( control ) or to ferric gluconate 125 mg intravenously with eight consecutive hemodialysis sessions ( intravenous iron ) . At r and omization , epoetin was increased 25 % in both groups ; further dosage changes were prohibited . At 6 wk , hemoglobin increased significantly more ( P=0.028 ) in the intravenous iron group ( 1.6 + /- 1.3 g/dl ) than in the control group ( 1.1 + /- 1.4 g/dl ) . Hemoglobin response occurred faster ( P=0.035 ) and more patients responded after intravenous iron than in the control group ( P=0.041 ) . Ferritin < or=800 or > 800 ng/ml had no relationship to the magnitude or likelihood of responsiveness to intravenous iron relative to the control group . Similarly , the superiority of intravenous iron compared with no iron was similar whether baseline TSAT was above or below the study median of 19 % . Ferritin decreased in control subjects ( -174 + /- 225 ng/ml ) and increased after intravenous iron ( 173 + /- 272 ng/ml ; P<0.001 ) . Intravenous iron result ed in a greater increase in TSAT than in control subjects ( 7.5 + /- 7.4 versus 1.8 + /- 5.2 % ; P<0.001 ) . Reticulocyte hemoglobin content fell only in control subjects , suggesting worsening iron deficiency . Administration of ferric gluconate ( 125 mg for eight treatments ) is superior to no iron therapy in anemic dialysis patients receiving adequate epoetin dosages and have a ferritin 500 to 1200 ng/ml and TSAT < or=25 % Background / Aims : Renal anemia is one of the commonest complications of chronic renal failure . Iron deficiency is the most common factor which affects the efficacy of recombinant human erythropoietin ( EPO ) therapy . Intravenous ( i.v . ) iron preparations are commonly used in Western countries , but iron sucrose is seldom used in Chinese patients on maintenance hemodialysis . The aim of the present study was to explore the safety and efficacy of i.v . iron sucrose in Chinese patients on maintenance hemodialysis and to explore the optimal administration frequency . Methods : One hundred and thirty-six patients on maintenance hemodialysis were involved in this r and omized , controlled , parallel-group , single-center trial . Seventy patients received i.v . iron sucrose ( Venofer ® , delivering 100 mg iron ) twice a week for 8 weeks , then once a week for another 4 weeks . The other 66 patients received oral ( p.o . ) ferrous succinate 200 mg t.i.d . for 12 weeks . Levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , hemoglobin ( Hb ) and hematocrit ( Hct ) were assessed at baseline and then again after 4 , 8 and 12 weeks of treatment . Results : There were no differences between i.v . and p.o . groups in terms of sex , age , duration of hemodialysis , dialysis frequency per week , EPO dosage per week , the level of intact parathyroid hormone , serum creatinine , blood urea nitrogen , or hematological parameters at baseline . After 8 and 12 weeks of treatment , mean Hb concentration and Hct were significantly increased in the i.v . group , and were also significantly higher than those in the p.o . group . Levels of SF and TSAT were also significantly increased in the i.v . group , and significantly higher than in the p.o . group . After 8 weeks , the response rate in the i.v . group was 88.6 % , which was significantly higher than that in the p.o . group . The mean EPO dose was significantly lower in the i.v . group than the p.o . group . Hb , Hct , SF and TSAT levels were maintained between 8 and 12 weeks in the i.v . group despite the decrease in dose frequency . There were no adverse events related to i.v . iron administration . Twenty-two patients in the p.o . group had adverse gastrointestinal effects . After 12 weeks , the cost of EPO + i.v . iron was significantly higher than the cost of EPO + p.o . iron . Conclusion : Intravenous iron sucrose can effectively increase serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and is well tolerated . Infusion of i.v . iron sucrose 100 mg per week can maintain serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and can permit reductions in the required dose of EPO . However , the total cost of i.v . iron is relatively high Background : Few studies compare oral to intravenous ( IV ) iron for managing anemia in patients with chronic kidney disease ( CKD ) not on dialysis . Methods : We enrolled 96 CKD anemic patients on erythropoietin in a r and omized , open-label , multicenter , controlled study . Patients received 29 days of oral FeSO4 ( 325 mg t.i.d . ) or intravenous ( IV ) iron sucrose ( 5 doses of 200 mg weekly ) . Assessment s were made up to 14 days after the last dose . Primary endpoints were changes in hemoglobin and ferritin , and clinical success was evaluated from the percent of patients with combined endpoints of rises in hemoglobin/ferritin , hemoglobin/ferritin/TSAT , and hemoglobin/TSAT . Results : There was no significant difference in hemoglobin values between IV and oral therapy . IV iron patients had greater increases in mean serum ferritin ( 288 ng/ml , p < 0.0001 ) compared to oral iron patients ( –5.1 ng/ml , p = NS ) . IV iron patients with baseline ferritin < 100 ng/ml had a greater increase in hemoglobin ( 1.4 g/dl ) compared to oral iron patients ( 0.9 g/dl ) ( p < 0.05 ) . More IV iron patients ( 54.2 % ) attained hemoglobin values > 11.0 g/dl compared to oral iron patients ( 31.3 % , p = 0.028 ) , and met hemoglobin/ferritin ( 62.5 % ) , hemoglobin/TSAT ( 47.9 % ) , hemoglobin/ferritin/TSAT ( 43.8 % ) , and ferritin/TSAT criteria ( 54.2 % ) than oral iron patients ( 0 , 22.9 , 0 , and 0 % , respectively ) . There were no serious side effects . Conclusions : These CKD patients had increases in both hemoglobin and ferritin following IV iron therapy , whereas those treated with oral iron had increases in hemoglobin without increases in iron stores . Iron sucrose , given weekly as 200 mg IV push over 5 min is an effective and safe anemia treatment in this population Objective . To analyze the effect of intravenous ferrous sucrose compared with oral ferrous sulphate on hematological parameters and quality of life in women with postpartum anemia . Design . Open r and omised controlled trial . Setting . Multicentre study comprising five obstetrical departments in Norway . Population . Hundred and twenty‐eight postpartum women with hemorrhagic anemia ( Hb between 6.5 g/100 ml and 8.5 g/100 ml ) . The intervention group ( 59 women ) received 600 mg iron sucrose intravenously followed by 200 mg iron sulphate daily from week 5 . The control group ( 70 women ) were given 200 mg iron sulphate daily . Methods . R and omisation and start of treatment occurred within 48 hours of the delivery . Participants were followed up at 4 , 8 and 12 weeks . Main outcome measures . Hemoglobin , ferritin and quality of life assessed with the Medical Outcomes Study Short Form 36 ( SF‐36 ) and the Fatigue Scale . Results . After 4 weeks the mean hemoglobin values in both groups were similar ( 11.9g/100ml vs. 12.3g/100ml , p = 0.89 ) . The mean serum ferritin value after 4 weeks was significantly higher in the intervention group with 13.7μg/L vs. 4.2μg/L in the control group ( p<0.001 ) . At 8 and 12 weeks the hematological parameters were similar . The total fatigue score was significantly improved in the intervention group at week 4 , 8 and 12 , whereas SF‐36 scores did not differ . Conclusion . Women who received 600 mg intravenous iron sucrose followed by st and ard oral iron after four weeks , replenished their iron stores more rapidly and had a more favorable development of the fatigue score indicating improved quality of life Bacteremic infections are a major cause of mortality and morbidity in chronic hemodialysis patients . New developments in managing these patients ( erythropoietin therapy , nasal mupirocin , long-term implanted catheters , and synthetic membranes ) may have altered the epidemiologic patterns of bacteremia in dialysis patients . This multicenter prospect i ve cross-sectional study was carried out to determine the current incidence of and risk factors for bacteremia in chronic hemodialysis patients in France . A total of 988 adults on chronic hemodialysis for 1 mo or longer was followed up prospect ively for 6 mo in 19 French dialysis units . The factors associated with the development of at least one bacteremic episode over 6 mo were determined using the multivariate Cox proportional hazards model . Staphylococcus aureus ( n=20 ) and coagulase-negative staphylococci ( n=15 ) were responsible for most of the 51 bacteremic episodes recorded . The incidence of bacteremia was 0.93 episode per 100 patient-months . Four risk factors for bacteremia were identified : ( 1 ) vascular access ( catheter versus fistula : RR=7.6 ; 95 % CI , 3.7 to 15.6 ) ; ( 2 ) history of bacteremia ( > or = 2 versus no previous episode : RR=7.3 ; 95 % CI , 3.2 to 16.4 ) ; ( 3 ) immunosuppressive therapy ( current versus no : RR=3.0 ; 95 % CI , 1.0 to 6.1 ) ; and ( 4 ) corpuscular hemoglobin ( per 1 g/dl increment : RR=0.7 ; 95 % CI , 0.6 to 0.9 ) . Catheters , especially long-term implanted catheters , were found to be the leading risk factor of bacteremia in chronic hemodialysis patients . There was a trend toward recurrence of bacteremia that was not associated with chronic staphylococcal nasal carriage . Synthetic membranes were not associated with a lower risk of bacteremia in this population of well dialyzed patients , but anemia linked to resistance to erythropoietin appeared to be a possible risk factor for bacteremia Objective . Patients with inflammatory bowel disease ( IBD ) often have low iron stores or anaemia . There is controversy about whether iron should be supplemented orally or intravenously ( i.v . ) . The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron . The primary end-points were response and remaining anaemia at the end of treatment ( EOT ) . Material and methods . Ninety-one patients with IBD and anaemia ( B-Hb < 115 g/L ) were r and omized to oral iron sulphate ( n=46 ) or intravenous iron sucrose ( n=45 ) treatment for 20 weeks . Results . Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group ( p=0.0009 ) . Only 22 patients ( 48 % ) tolerated the prescribed oral dose , and 52 % reduced the dose or withdrew from treatment because of poor tolerance . At EOT , 47 % patients in the oral iron group increased their B-Hb by ≥20 g/L , compared with 66 % in the intravenous iron group ( p=0.07 ) . In the oral iron group , 41 % still had anaemia versus 16 % of the patients in the intravenous iron group ( p=0.007 ) , and 22 % versus 42 % reached their reference B-Hb level ( p=0.04 ) . Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron ( p=0.002 ) . Under treatment with intravenous iron , 74 % of the patients had no anaemia and normal S-ferritin levels ( > 25 µg/L ) at EOT compared with 48 % of patients receiving oral iron ( p=0.013 ) . Conclusions . Treatment with intravenous iron sucrose is effective , safe , well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD OBJECTIVE To evaluate the safety and efficacy of intravenous iron sucrose complex ( ISC ) as compared with oral ferrous sulfate in the treatment of iron deficiency anemia during pregnancy . STUDY DESIGN prospect i ve , open , controlled study in which pregnant women with iron deficiency anemia were sequentially selected from the antenatal clinic and assigned either to ISC ( study group ) or to ferrous sulfate ( control group ) . METHODS Each study patient was given the total calculated amount of ICS ( Hb deficit ( g/l ) x body weight ( kg ) x 0.3 ) in divided doses ( 200 mg ( elemental iron ) in 100 ml normal saline intravenously over 1 h daily ) followed by 10 mg/kg to replenish iron stores . Each patient of the control group was given ferrous sulfate 300 mg ( 60 mg elemental iron ) orally three times a day . All patients were monitored for adverse effects , clinical and laboratory response . RESULTS There were 52 patients and 59 controls . ISC group achieved a significantly higher Hb level ( 128.5 + /- 6.6 g/l vs. 111.4 + /- 12.4 g/l in the control group P < or = 0.001 ) in a shorter period ( 6.9 + /- 1.8 weeks vs. 14.9 + /- 3.1 weeks in the control group , P < or = 0.001 ) . ISC complex group showed no major side effects while 4 ( 6 % ) of the control group could not tolerate ferrous sulfate , 18 ( 30 % ) complained of disturbing gastrointestinal symptoms and 18 ( 30 % ) had poor compliance . CONCLUSION We conclude that ISC is safe and effective in the treatment of iron deficiency anemia during pregnancy OBJECTIVES Our objective was to evaluate in a double-blind , r and omized , placebo-controlled study possible modifications in NT-pro-brain natriuretic peptide ( NT-proBNP ) and C-reactive protein ( CRP ) levels together with clinical and functional parameters , in a group of anemic patients with chronic heart failure ( CHF ) and chronic renal failure ( CRF ) receiving intravenous iron therapy , without recombinant human erythropoietin ( rhEPO ) , versus placebo . BACKGROUND Chronic heart failure and CRF associated with absolute or relative iron deficiency anemia is a common problem . This situation is linked with a variable inflammatory status . Both NT-proBNP and CRP are recognized markers for left ventricular dysfunction and inflammatory status , respectively . In this double-blind , r and omized , placebo-controlled study , modifications in NT-proBNP and CRP level and clinical and functional parameters , in anemic patients with CHF and CRF receiving intravenous iron therapy , without rhEPO , versus placebo were evaluated . METHODS Forty patients with hemoglobin ( Hb ) < 12.5 g/dl , transferrin saturation < 20 % , ferritin < 100 ng/ml , creatinine clearance ( CrCl ) < 90 ml/min , and left ventricular ejection fraction ( LVEF ) < or = 35 % were r and omized into 2 groups ( n = 20 for each ) . For 5 weeks , group A received isotonic saline solution and group B received iron sucrose complex , 200 mg weekly . Minnesota Living with Heart Failure Question naire ( MLHFQ ) and 6-min walk ( 6MW ) test were performed . NT-pro brain natriuretic peptide and CRP were evaluated throughout the study . No patients received erythroprotein any time . RESULTS After 6 months follow-up , group B showed better hematology values and CrCl ( p < 0.01 ) and lower NT-proBNP ( 117.5 + /- 87.4 pg/ml vs. 450.9 + /- 248.8 pg/ml , p < 0.01 ) and CRP ( 2.3 + /- 0.8 mg/l vs. 6.5 + /- 3.7 mg/l , p < 0.01 ) . There was a correlation initially ( p < 0.01 ) between Hb and NT-proBNP ( group A : r = -0.94 and group B : r = -0.81 ) and after 6 months only in group A : r = -0.80 . Similar correlations were observed with Hb and CRP . Left ventricular ejection fraction percentage ( 35.7 + /- 4.7 vs. 28.8 + /- 2.4 ) , MLHFQ score , and 6MW test were all improved in group B ( p < 0.01 ) . Additionally , group B had fewer hospitalizations : 0 of 20 versus group A , 5 of 20 ( p < 0.01 ; relative risk = 2.33 ) . CONCLUSIONS Intravenous iron therapy without rhEPO substantially reduced NT-proBNP and inflammatory status in anemic patients with CHF and moderate CRF . This situation was associated with an improvement in LVEF , NYHA functional class , exercise capacity , renal function , and better quality of life BACKGROUND To compare the efficacy of oral and intravenous administration of iron supplements for treating postpartum anemia . METHODS One hundred and four anemic postpartum women were studied prospect ively . The criteria for the diagnosis of anemia were Hb<8 gr/dl and ferritine<10 microg/dl . They were r and omised into two groups . Group A consisted of 78 women who received i.v . a total amount of 300 mg iron sucrose in three days . Group B consisted of 26 women , who received orally 800 mg iron proteinsuccinylate daily for four weeks . RESULTS At the end of the study , in group A the increase of Hb mean level was 4.6 gr/dl and of ferritin mean level was 105 mg/L. In group B the increase in hemoglobin mean level was 2.3 gr/dl and ferritin mean level was 68 mg/L. There was significant difference in the increase of hemoglobin level ( p=0.0001 ) and also in the increase in ferritin level ( p=0.0004 ) between the two groups . CONCLUSION Intravenous administration of iron sucrose seems to be safe and it helps postpartum women to recover early from anemia OBJECTIVE Is intravenous iron therapy as efficient as oral iron supplementation in patients undergoing autologous blood donation ? DESIGN Prospect i ve , r and omized study . PATIENTS AND SETTING 30 male and 30 female patients , separated into two groups were examined prior to total hip replacement . INTERVENTIONS Patients of group O were given 6 x 50 mg Fe2 + aspartate/day orally , and patients of group P were given 0.75 mg/kg BW complex-bound Fe3 + once a week by infusion . In both groups therapy was started two weeks prior to the first donation . The substitution was continued the following six weeks until surgery . Hemoglobin , ferritin plasma concentrations and reticulocytes were monitored . The appearance of unwanted side effects was studied by question naire . RESULTS Hb decreased significantly in both groups . A difference was seen in the reticulocyte count and in the ferritin levels . Here we found a significant increase in group P compared with group O. 40 % of the patients who took the iron orally complained about unwanted side effects such as obstipation and diarrhoea , whereas none of the patients of the parenteral group had any complaints . CONCLUSIONS Stimulation of the erythropoiesis appeared to be more efficient with intravenous iron therapy than with oral iron supplementation . The oral dose has in about 40 % unwanted side effects . For this reason a parenteral iron therapy can be considered , but one must be aware that in some cases dangerous anaphylactic reactions could appear OBJECTIVES The aim of this study was to examine whether intravenous iron III-hydroxide sucrose complex ( IHSC ) used alone was sufficient to provide rapid correction of anemia after cardiac surgery and whether additional stimulation of erythropoiesis is possible by means of a single low dose of recombinant-human erythropoietin ( r-HuEPO ) administration . DESIGN Prospect i ve , r and omized , double-blind study . SETTING The study was conducted in a university hospital . PARTICIPANTS One hundred twenty American Society of Anesthesiologists II or III patients , who underwent elective cardiac surgery using cardiopulmonary bypass and in whom postpump hemoglobin ranged between 7 and 10 g/dL. INTERVENTIONS Patients were divided into 3 groups : group I = control ; group II received postoperative intravenous iron supplementation with an iron III-hydroxide sucrose complex ( IHSC ) ; and group III received IV iron and a single dose of r-HuEPO ( 300 U/kg ) . MEASUREMENTS AND RESULTS No significant difference in transfusion needs was observed among the 3 groups ( 22 % , 25 % , and 17 % of patients transfused in groups I , II , and III , respectively ) . Hemoglobin levels , reticulocyte counts , and serum ferritin levels were evaluated at different time intervals ( until day 30 postoperatively ) . No side effects because of iron administration were noted in the study . Reticulocyte counts increased rapidly at day 5 ( 2.24 % + /- 1.11 % , 1.99 % + /- 1.44 % , and 3.84 % + /- 2.02 % in groups I , II , and III , respectively ) and decreased after day 15 in the 3 groups . Ferritin levels increased significantly at day 5 in the 2 treated groups ( 899.33 + /- 321.55 ng/mL in group II , 845.75 + /- 289.96 ng/mL in group III v 463.15 + /- 227.74 ng/mL in group I ) . In group I , ferritin levels , after a slight elevation on day 5 , decreased at day 15 to lower than baseline levels . No significant difference in hemoglobin increase was noted among the 3 groups . CONCLUSION Postoperative intravenous iron supplementation alone or in combination with a single dose of r-HuEPO ( 300 U/kg ) is not effective in correcting anemia after cardiac surgery Sixty pregnant patients with a haemoglobin ( Hb ) less than 8 g/dl and proven iron-deficiency anaemia were r and omly allocated to two treatment groups . Group A received the usual recommended dose of iron dextran ( Imferon ; Fisons ) and group B received two-thirds of the recommended dose . A further 30 patients received oral iron ( group C ) . There was no difference in Hb value between the three groups 4 weeks after treatment or 3 months after delivery . At 6 months after delivery , a higher mean Hb value was found in the patients in group A than those in groups B and C. Significantly higher serum ferritin levels were found in group A and this difference was still present 6 months postnatally . There was no significant difference in the incidence of delayed reactions between the two groups who received iron dextran BACKGROUND Restless legs syndrome ( RLS ) is a common disorder in patients with end-stage renal disease ( ESRD ) that causes motor agitation and insomnia . Because RLS has been associated with iron deficiency , we sought to investigate the effects of intravenous ( IV ) iron dextran on symptoms of RLS in a double-blind placebo-controlled trial . METHODS Patients determined to have RLS by International RLS Study Group criteria were administered either iron dextran , 1,000 mg , or normal saline IV in a blinded fashion . Patient demographic data were collected , and blood chemistry tests , liver function studies , serum iron levels , ferritin levels , and total iron-binding capacity were obtained at baseline and 1 , 2 , and 4 weeks postinfusion . Side effects or adverse events to interventions were monitored , and RLS symptoms were assessed by a rating scale at the same intervals . RESULTS Eleven patients were r and omly assigned to the administration of iron dextran , and 14 patients to the administration of saline .  RLS severity scores were slightly higher in the placebo group at baseline , but hemoglobin levels , iron stores , and other biochemical parameters did not differ . Although no change in symptoms were seen in the placebo-treated group , significant improvement in RLS symptom scores in response to iron dextran was seen 1 week after infusion ( -2 ; interquartile range [ IQR ] , -6 to -1 ; P = 0.03 , Wilcoxon 's rank sums ) , but was greatest at 2 weeks ( -3 ; IQR , -5 to -2 compared with -1 to 0 ; P = 0.01 ) . Salutary effects of iron persisted at 4 weeks , but were no longer statistically significant . The significant increase in serum ferritin levels and iron saturation observed in the iron dextran-treated group was not seen in the placebo-treated group . No differences in adverse events were noted between groups . CONCLUSION High-dose iron dextran infusion is associated with a significant , but transient , reduction in symptoms of RLS in patients with ESRD For nearly half a century , parenteral iron has been considered dangerous and for use only in extreme situations and when oral iron was not tolerated . This proscription was based largely on poorly characterised and infrequent anaphylactoid reactions to the high-molecular-weight dextran preparation ( Imferon ) that for most of this time was the only product available . Moreover , when parenteral iron was necessary , the recommended approach was small intramuscular doses ( ≤100 mg ) , even after intravenous administration of the total iron defi cit as a single dose or as repetitive boluses was shown to be as safe and eff ective as the intramuscular route . This mindset persists despite the subsequent introduction of low-molecular-weight iron dextran and two iron salt preparations , ferric gluconate and iron saccharate ( the latter is also known as iron sucrose ) , all of which are associated with fewer serious adverse events than the high-molecular-weight dextran . The introduction of recombinant erythropoietin for dialysis patients was associated with the development , in some individuals , of functional iron defi ciency that limited effi cacy . Intravenous iron , unlike oral iron , improves erythropoietic response in dialysis patients , and is now routinely used . The discovery of the iron regulatory peptide , hepcidin , has improved our underst and ing of the anaemia of chronic infl ammatory states , including cancer . Hepcidin is upregulated in these conditions , result ing in increased synthesis by the liver . Hepcidin inhibits iron transport across cell membranes , which decreases the accessibility of storage iron and gastrointestinal absorption of dietary iron , leading to an increased frequency of iron-restricted erythropoiesis , especially during therapy with recombinant erythropoietin . The most frequent laboratory fi ndings during the anaemia of chronic infl ammation are hypoferraemia and a low percent transferrin saturation , although these fi ndings are not always present . The increasing use of recombinant erythropoietin to treat anaemia in patients with chronic diseases has exp and ed the population of patients with functional iron defi ciency and increased interest in safe rational approaches to parenteral iron therapy . There is mounting evidence that anaemic patients with cancer undergoing chemotherapy and receiving  recombinant erythropoietin respond better when parenteral iron is administered . This benefi t is independent of baseline iron variables , such as ferritin , low percentage transferrin saturation , and stainable marrow haemosiderin , leaving the clinician in need of laboratory variables to reliably detect iron-restricted erythropoiesis in patients with infl ammatory illnesses and to predict improvement of erythropoietic response to parenteral iron in the setting of infl ammatory illness . Two new laboratory measures look promising : percent hypochromic red blood cells and reticulocyte haemoglobin content . These tests are reliable and accurate correlates of functional iron defi ciency . Although these investigations are not yet widely available , their use will probably exp and and guide identifi cation of functional iron defi ciency and rational intervention with parenteral iron . Currently , four parenteral iron preparations are available ( table ) . No r and omised trials have compared the safety and effi cacy of any of these agents . The largest retrospective review of dialysis experience suggests that most serious adverse events have been associated with the high-molecular-weight iron dextrans ( Imferon , which is no longer available and the current preparation , Dexferrum ) and are rare ( < 1:200 000 ) with the low-molecular-weight iron dextran or the two iron salts ( fi gure ) . Adverse event rates might be somewhat higher in patients with infl ammatory diseases in which immune-mediated drug reactions  may be observed more commonly than in dialysis patients . Some of the adverse clinical experience with parenteral iron is due to inappropriate supportive care . Myalgias , when they include chest and back discomfort , are mistakenly described as anaphylaxis , prompting Low – molecular – weight iron dextran Iron saccharate Ferric gluconate High – molecular – weight iron In view of current uncertainty regarding the optimum route for iron supplementation in patients receiving recombinant human erythropoietin ( EPO )  , a prospect i ve r and omized controlled study was design ed to investigate this issue . All iron-replete renal failure patients commencing EPO who had a hemoglobin concentration < 8.5 g/dl and an initial serum ferritin level of 100 to 800 micrograms/liter were r and omized into three groups with different iron supplementation : Group 1 , i.v . iron dextran 5 ml every 2 weeks ; Group 2 , oral ferrous sulphate 200 mg tds ; Group 3 , no iron . All patients were treated with 25 U/kg of EPO thrice weekly subcutaneously . The hemoglobin concentration , reticulocyte count , serum ferritin , transferrin saturation , and EPO dose were monitored every two weeks for the first four months . Thirty-seven patients entered the study ( 12 i.v . , 13 oral , 12 no iron ) . The three groups were equivalent with regard to age , sex , and other demographic details . Even allowing for dosage adjustments , the hemoglobin response in the group receiving i.v . iron ( 7.3 + /- 0.8 to 11.9 + /- 1.2 g/dl ) was significantly greater than that for the other two groups ( 7.2 + /- 1.1 to 10.2 + /- 1.4 g/dl and 7.3 + /- 0.8 to 9.9 + /- 1.6 g/dl for Groups 2 and 3 , respectively ; P < 0.005 for both groups vs. Group 1 at 16 weeks ) . There was no difference between the groups supplemented with oral iron and no iron . Serum ferritin levels remained constant in those receiving i.v . iron ( 345 + /- 273 to 359 + /- 140 micrograms/liter ) , in contrast to the other two groups in which ferritin levels fell significantly ( 309 + /- 218 to 116 + /- 87 micrograms/liter and 458 + /- 206 to 131 + /- 121 micrograms/liter for Groups 2 and 3 , respectively ; P < 0.0005 for Group 1 vs. Group 2 , and P < 0.005 for Group 1 vs. Group 3 at 16 weeks ) . Dosage requirements of EPO  were less in Group 1 ( 1202 + /- 229 U/kg/16 weeks ) than in Group 2 ( 1294 + /- 314 U/kg/16 weeks ) or Group 3 ( 1475 + /- 311 U/kg/16 weeks ; P < 0.05 vs. Group 1 ) . The results of this study suggest that , even in iron-replete patients , those supplemented with i.v . iron have an enhanced hemoglobin response to EPO with better maintenance of iron stores and lower dosage requirements of EPO , compared with those patients receiving oral iron and no iron supplementation OBJECTIVES To compare the efficacy of intravenous iron and oral iron for prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy . MATERIAL S AND METHODS Sixty-four non anemic gynecologic cancer patients receiving adjuvant platinum-based chemotherapy were stratified and r and omized according to baseline hemoglobin levels and chemotherapy regimen . The study group received 200 mg of intravenous iron sucrose immediately after each chemotherapy infusion . The control group received oral ferrous fumarate at a dose of 200 mg three times a day . Complete blood count was monitored before each chemotherapy infusion . Blood transfusions were given if hemoglobin level was below 10mg/dl . RESULTS There were 32 patients in each group . No significant differences in baseline hemoglobin levels and baseline characteristics were demonstrated between both groups . Nine patients ( 28.1 % ) in the study group and 18 patients ( 56.3 % ) in the control group required blood transfusion through 6 cycles of chemotherapy ( p=0.02 ) . Fewer median number of total packed red cell units were required in the study group compared to the control group ( 0 and 0.5 unit , respectively , p=0.04 ) . Serious adverse events and hypersensitivity reactions were not reported . However , constipation was significantly higher in the control group ( 3.1 % and 40.6 % , p=<0.001 ) . CONCLUSIONS Intravenous iron is an effective , well-tolerated treatment for primary prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy , associated with less constipation than the oral formulation BACKGROUND Currently available intravenous ( IV ) iron agents vary in indication , dosing regimens and safety profiles . Ferric carboxymaltose ( FCM ) is a stable , non-dextran-containing iron formulation developed for rapid IV administration in high doses with controlled delivery of iron into target tissues . The objective of the present study was to evaluate the safety of FCM compared with st and ard medical care ( SMC ) in dialysis ( HD ) and non-dialysis-dependent ( NDD ) chronic kidney disease ( CKD ) patients . METHODS Adults 18 - 85 years of age with CKD were enrolled . NDD-CKD ( n = 204 ) patients received an undiluted IV dose of FCM ( 15 mg/kg to a maximum of 1000 mg IV ) and HD-CKD ( n = 50 ) patients received an undiluted IV push of 200 mg ~30 - 60 min into the dialysis session . Subjects r and omized to the SMC group ( n = 259 ) received treatment determined by the investigator that could include oral iron , IV iron or no iron . RESULTS Single doses of FCM of 200 mg in HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated . Incidences of treatment-emergent adverse events were similar between the groups : 30.3 % ( 77 of 254 ) in the FCM group and 32.8 % ( 85 of 259 ) in the SMC group . Incidences of serious adverse events were higher in the SMC group overall and in patients receiving iron sucrose or sodium ferric gluconate . There were no clinical ly significant differences in laboratory or clinical chemistry values or vital signs between the groups . There were no statistically significant differences between the FCM and SMC groups in indices of hemoglobin ( Hb ) improvement , including proportions of patients achieving a ≥ 1 g/dL increase in Hb and proportions of patients achieving Hb level of > 12 g/dL. CONCLUSION FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations AIM 135 puerperal women with iron deficiency anemia participated in our prospect i ve r and omized controlled trial in order to investigate alternative treatments to blood transfusion for anemia . MATERIAL S AND METHODS The criteria for the diagnosis of anemia were Hb < 8 g/dl and ferritine < 10 microg/dl . Women were r and omly separated in two groups , A and B. Women of group A ( n = 109 women ) received a total amount of 1000 mg low molecular weight ( LMW ) iron-dextran intravenously in two doses . Group B ( n = 26 ) was the control group . They received orally 800 mg daily for 30 days of iron protein-succinylate . Three weeks later women of both groups underwent a full blood count analysis . RESULTS Hemoglobin and ferritin levels increased significantly in group A compared to group B ( p < 0.0001 ) . No adverse side-effects due to the treatment were noted in either group . CONCLUSION It seems that total iron-dextran infusion is a safe and rapid therapy of iron-deficiency postpartum anemia increases the Hb level more rapidly than oral ferrous sulfate , and it also appears to replenish iron stores more rapidly This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks ( Q3W ) at fixed doses of 300 or 500 μg with or without intravenous ( IV ) iron in treating anemia in patients receiving multicycle chemotherapy . This Phase 2 , double‐blind , 2 × 2 factorial study r and omized patients to one of four treatment arms ; darbepoetin alfa 300 μg  ( n = 62 ) , darbepoetin alfa 300 μg plus IV iron ( n = 60 ) , darbepoetin alfa 500 μg ( n = 60 ) , or darbepoetin alfa 500 μg plus IV iron ( n = 60 ) . Patients had nonmyeloid malignancies , hemoglobin levels ≤10 g dL−1 , and no iron deficiency . Primary endpoint was achievement of target hemoglobin ( ≥11 g dL−1 ) . Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue ( FACT‐F ) score from baseline to end of study . Safety was evaluated by incidence of adverse events . No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed , therefore , results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups . Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin ( 75 and 78 % , respectively ) ; Kaplan – Meier median time to target hemoglobin was 10 and 8 weeks , respectively . More patients receiving IV iron ( 82 % ) than not receiving IV iron ( 72 % ) achieved hemoglobin target . Adverse events profiles were similar for darbepoetin alfa treatment groups . Transient anaphylactoid reactions were reported in two patients receiving IV iron . Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit , while added IV iron  improved treatment response in these patients . Am . J. Hematol . , 2010 . © 2010 Wiley‐Liss , AIM Iron deficiency is a leading cause of anemia in pregnancy . The present study aim ed to compare the efficacy of oral and intravenous iron therapy in improving iron deficiency anemia in pregnancy and restoring iron stores , compare the obstetric outcome in the two groups and evaluate the safety of intravenous iron sucrose . MATERIAL AND METHODS This was a prospect i ve study , where 100 anemic antenatal women with hemoglobin 7 - 9 g/dL , mean corpuscular volume < 85 fL and serum ferritin < 15 ng/mL , were r and omized into two groups . In group A ( n=50 ) , the women received 200 mg tablets of ferrous sulphate , each containing 60 mg elemental iron , three times a day for 4 weeks . In group B ( n=50 ) , iron sucrose was given in divided doses of 200 mg each on alternate days by slow intravenous infusion . Primary outcome measure was treatment efficacy , assessed by measurement of hemoglobin , red blood cell indices and reticulocytes on days 7 , 14 , 21 , and 30 and at delivery , and of ferritin on day 30 and at delivery . Any side-effects of treatment and the neonatal outcome were studied as secondary outcome measures . RESULTS There was a statistically significant difference in increase of hemoglobin levels ( 3.1g/dL in group A vs 5.1 g/dL in group B ; P=0.002 ) and ferritin levels between the two groups on day 30 ( P=0.005 ) . The adverse effects from iron treatment were mild but more prominent in group A. Neonatal outcome was comparable in the two groups . CONCLUSION Intravenous administration of iron sucrose is a safe treatment for correction of anemia in pregnancy , without serious side-effects OBJECTIVES We tested the hypothesis that intravenous iron improves exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure ( CHF ) and iron deficiency . BACKGROUND Anemia is common in heart failure . Iron metabolism is disturbed , and administration of iron might improve both symptoms and exercise tolerance . METHODS We r and omized 35 patients with CHF ( age 64 + /- 13 years , peak oxygen consumption [ pVO2 ] 14.0 + /- 2.7 ml/kg/min ) to 16 weeks of intravenous iron ( 200 mg weekly until ferritin > 500 ng/ml , 200 mg monthly thereafter ) or no treatment  in a 2:1 ratio . Ferritin was required to be < 100 ng/ml or ferritin 100 to 300 ng/ml with transferrin saturation < 20 % . Patients were stratified according to hemoglobin levels ( < 12.5 g/dl [ anemic group ] vs. 12.5 to 14.5 g/dl [ nonanemic group ] ) . The observer-blinded primary end point was the change in absolute pVO2 . RESULTS The difference ( 95 % confidence interval [ CI ] ) in the mean changes from baseline to end of study between the iron and control groups was 273 ( 151 to 396 ) ng/ml for ferritin ( p < 0.0001 ) , 0.1 ( -0.8 to 0.9 ) g/dl for hemoglobin ( p = 0.9 ) , 96 ( -12 to 205 ) ml/min for absolute pVO2 ( p = 0.08 ) , 2.2 ( 0.5 to 4.0 ) ml/kg/min for pVO2/kg ( p = 0.01 ) , 60 ( -6 to 126 ) s for treadmill exercise duration ( p = 0.08 ) , -0.6 ( -0.9 to -0.2 ) for New York Heart Association ( NYHA ) functional class ( p = 0.007 ) , and 1.7 ( 0.7 to 2.6 ) for patient global assessment ( p = 0.002 ) . In anemic patients ( n = 18 ) , the difference ( 95 % CI ) was 204 ( 31 to 378 ) ml/min for absolute pVO2 ( p = 0.02 ) , and 3.9 ( 1.1 to 6.8 ) ml/kg/min for pVO2/kg ( p = 0.01 ) . In nonanemic patients , NYHA functional class improved ( p = 0.06 ) . Adverse events were similar . CONCLUSIONS Intravenous iron loading improved exercise capacity and symptoms in patients with CHF and evidence of abnormal iron metabolism . Benefits were more evident in anemic patients . ( Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure ; http://www . clinical trials.gov/ct/show/NCT00125996 ; NCT00125996 ) PURPOSE The concomitant use of intravenous ( IV ) iron as a supplement to erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia is controversial . This study was design ed to evaluate the efficacy and safety of darbepoetin alpha given with IV iron versus with local st and ard practice ( oral iron or no iron ) . PATIENTS AND METHODS In this multicenter , r and omized , open-label , phase III study , 396 patients with nonmyeloid malignancies and hemoglobin ( Hb ) less than 11 g/dL received darbepoetin alpha 500 microg with ( n = 200 ) or without ( n = 196 ) IV iron once every 3 weeks ( Q3W ) for 16 weeks . RESULTS The hematopoietic response rate ( proportion of patients achieving Hb > or= 12 g/dL or Hb increase of > or= 2 g/dL from baseline ) was significantly higher in the IV iron group : 86 % versus 73 % in the st and ard practice group ( difference of 13 % [ 95 % CI , 3 % to 23 % ] ; P = .011 ) . Fewer RBC transfusions ( week 5 to the end of the treatment period ) occurred in the IV iron group : 9 % versus 20 % in the st and ard practice group ( difference of -11 % [ 95 % CI , -18 % to -3 % ] ; P = .005 ) . Both treatments were well tolerated with no notable differences in adverse events . Serious adverse events related to iron occurred in 3 % of patients in the IV iron group and were mostly gastrointestinal in nature . CONCLUSION Addition of IV iron to darbepoetin alpha Q3W in patients with chemotherapy-induced anemia was well tolerated , result ing in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alpha alone PURPOSE Unresponsiveness to erythropoiesis-stimulating agents , occurring in 30 % to 50 % of patients , is a major limitation to the treatment of chemotherapy-related anemia . We have prospect ively evaluated whether intravenous iron can increase the proportion of patients with chemotherapy-related anemia who respond to darbepoetin .  PATIENTS AND METHODS Between December 2004 and February 2006 , 149 patients with lung , gynecologic , breast , and colorectal cancers and > or= 12 weeks of planned chemotherapy were enrolled from 33 institutions . Patients were required to have hemoglobin < or= 11 g/L and no absolute or functional iron deficiency . All patients received darbepoetin 150 microg subcutaneously once weekly for 12 weeks and were r and omly assigned to sodium ferric gluconate 125 mg intravenously ( IV ) weekly for the first 6 weeks ( n = 73 ) or no iron ( n = 76 ) . Primary end point of the study was the percentage of patients achieving hematopoietic response ( hemoglobin > or= 12 g/dL or > or= 2 g/dL increase ) . RESULTS Hematopoietic response by intention-to-treat analysis was 76.7 % ( 95%CI , 65.4 % to 85.8 % ) in the darbepoetin/iron group and 61.8 % ( 95%CI , 50.0 % to 72.7 % ) in the darbepoetin group ( P = .0495 ) . Among patients fulfilling eligibility criteria and having received at least four darbepoetin administrations , hematopoietic responses in the darbepoetin/iron group ( n = 53 ) and in the darbepoetin-only group ( n = 50 ) were 92.5 % ( 95 % CI , 81.8 % to 97.9 % ) and 70 % ( 95 % CI , 55.4 % to 82.1 % ) , respectively ( P = .0033 ) . Increase of hemoglobin during treatment period showed a time profile favoring darbepoetin/iron with statistically significant effect from week 5 on . The safety profile was comparable in the two arms . CONCLUSION In patients with chemotherapy-related anemia and no iron deficiency , IV iron supplementation significantly reduces treatment failures to darbepoetin without additional toxicity
target: There was no increased risk of infections with IV iron .
  Gastrointestinal AEs were reduced with IV iron .
  CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
  Infusion reactions are more pronounced with IV iron
background: OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .