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Clinical UM Guideline
|Recombinant Erythropoietin Products
|Guideline #:
|Current Effective Date:
|Last Review Date:
This document addresses recombinant, or man-made, erythropoietin products:
Erythropoietin (EPO) is a hormone naturally produced in the body, primarily by the kidneys, which stimulates the bone marrow to produce red blood cells (RBCs). If the body does not produce enough EPO, severe anemia can occur. This often occurs in people whose kidneys are not functioning properly. EPO is used to treat severe anemia in chronic kidney disease or other conditions, such as acquired immune deficiency syndrome (AIDS), cancer, or surgery.
|Clinical Indications
Medically Necessary:
Darbepoetin alfa may be considered medically necessary when the criteria below are:
Epoetin alfa may be considered medically necessary when the criteria below are met:
Epoetin alfa may also be considered medically necessary when the criteria below are met:
Methoxy polyethylene glycol-epoetin beta is considered medically necessary when the criteria below are met:
Not Medically Necessary:
DARBEPOETIN ALFA and EPOETIN ALFA
Use of epoetin alfa or darbepoetin alfa is considered not medically necessary for all of the following:
Use of methoxy polyethylene glycol-epoetin beta is considered not medically necessary for all of the following:
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|Injection, darbepoetin alfa, 1 microgram (non-ESRD use) [Aranesp]
|Injection, darbepoetin alfa, 1 microgram (for ESRD on dialysis) [Aranesp]
|Injection, epoetin alfa (for non-ESRD use), 1000 units [Epogen, Procrit]
|Injection, epoetin beta, 1 microgram, (for ESRD on dialysis) [Mircera]
|Injection, epoetin beta, 1 microgram, (for non-ESRD use) [Mircera]
|Injection, epoetin alfa, 100 units (for ESRD on dialysis) [Epogen, Procrit]
|Home therapy; hematopoietic hormone injection therapy (e.g., erythropoietin, G-CSF, GM-CSF), per diem [when specified as erythropoietin]
|Erythropoetic stimulating agent (ESA) administered to treat anemia due to anti-cancer chemotherapy
|Erythropoetic stimulating agent (ESA) administered to treat anemia due to anti-cancer radiotherapy
|Erythropoetic stimulating agent (ESA) administered to treat anemia not due to anti-cancer radiotherapy or anti-cancer chemotherapy
|ICD-10 Diagnosis
|All diagnoses
|Discussion/General Information
Anemia is a condition that occurs when the number of RBCs is below the normal level. Oxygen is carried throughout the body by RBCs. Tissue hypoxia, the lack of adequate oxygenation to the tissues, usually triggers erythropoietin, an endogenous hormone normally produced primarily by the kidneys, to stimulate the bone marrow and increase production of RBCs, also called erythropoiesis. Treatment of anemia includes correcting the underlying causes of anemia, blood transfusions or administering erythropoietin products, also called erythropoietin stimulating agents (ESAs, such as epoetin alfa and darbepoetin) or continuous erythropoietin receptor activator (CERA, such as methoxy polyethylene glycol-epoetin beta). An adequate diagnostic workup to identify treatable causes of anemia should be performed prior to treatment of anemia.
Response to therapy with erythropoietin products may be assessed by the stabilization of or rise in hemoglobin or hematocrit. Individual characteristics and diagnosis should be considered when determining whether a response to therapy has occurred.
Darbepoetin Alfa and Epoetin Alfa
The U.S. Food and Drug Administration (FDA) approved epoetin alfa for the treatment of anemia in chronic kidney disease and in individuals with non-myeloid malignancies where the anemia is due to the effect of concomitantly administered myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy. Epoetin alfa is also FDA approved for treatment of anemia in zidovudine-treated HIV-infected individuals, and to reduce allogeneic blood transfusions in noncardiac, nonvascular surgical cases that are at high risk for perioperative transfusions with significant, anticipated blood loss (Product Information Labels, 2013).
Darbepoetin alfa is another FDA-approved ESA for similar indications. Because darbepoetin alfa is long acting, less frequent dosing is required (weekly or biweekly for individuals on dialysis). Glaspy and colleagues (2001) performed randomized trials to confirm the data from dose-finding studies, which suggest darbepoetin alfa can be administered effectively as infrequently as once per chemotherapy cycle (weekly or once every 3 weeks). Comparative studies were performed to evaluate darbepoetin alfa in individuals with cancer (Glaspy, 2001; Hedenus, 2002; Kotasek, 2000, 2001, 2003; Pirker, 2001).
The safety and efficacy of both darbepoetin and epoetin alfa are similar in anemia of chronic kidney disease or chemotherapy-induced anemia (Allon, 2002; Herrington, 2005). There are no reported trials comparing the two formulations of epoetin (Product Information Labels, 2013). There is no data to make a recommendation regarding the use of the epoetin alfa products over darbepoetin alfa for the treatment anemia from chronic renal failure and the treatment in individuals with non-myeloid malignancies with chemotherapy induced anemia.
Initial studies explored the use of erythropoietin in a variety of settings, testing various dosing and scheduling regimens. These trials typically were small in size and used a variety of regimens and schedules. Some failed to demonstrate significant benefit, perhaps because of the populations enrolled, the study design, or the limitations of the agent as a therapy. While there is evidence to support the use of ESAs to treat anemia related to chronic kidney disease and anemia in individuals with non-myeloid cancer receiving chemotherapy, studies have reported adverse outcomes in unlabeled indications, which resulted in warnings from the FDA in March and November 2007.
In August 2008, the Product Information Labels for ESAs were updated, as the FDA invoked authority to address the risk of increased mortality and poorer tumor outcomes when ESAs are given to individuals receiving treatment for head and neck cancer, breast cancer, non-small cell lung cancer, or cervical cancer, and in anemic individuals not receiving chemotherapy for cancer. Data from multiple trials demonstrated ESA use decreased locoregional control or progression-free survival and overall survival. The use of the lowest dose of epoetin alfa or darbepoetin alfa to achieve and maintain the lowest hemoglobin concentration to avoid the need for RBC transfusion was recommended.
A Cochrane Review (Bohlius, 2009) included analysis of 53 ESA trials with a total of 13,933 individuals with cancer. There were 1530 deaths on-study, and 4993 overall. The authors concluded ESAs "increased on-study mortality and worsened overall survival."
The FDA announced in February 2010, a requirement that "All ESAs are to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs." The action was taken as studies had shown:
ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions (FDA, 2010).
The drug manufacturer, Amgen, developed an ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program for healthcare professionals who prescribe ESAs to individuals with cancer. Currently, providers who prescribe ESAs for oncologic indications must enroll in the ESA APRISE program and receive training.
In June 2011, the Product Information Labels for the ESAs were updated in collaboration with the FDA. Data from controlled clinical trials of individuals with CKD included increased risks for death, serious adverse cardiovascular reactions and stroke when hemoglobin targets of 11g/dL or greater were utilized. The trial data did not identify a hemoglobin target level, ESA dose, or dosing strategy that did not increase risk. Additional label recommendations for ESA use in individuals with CKD not on dialysis include "the rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal." Additional recommendations for individuals with CKD from the Product Information Labels (2013) include:
Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Individualize dosing and use the lowest dose of ESA sufficient to reduce the need for RBC transfusion.
In the presence of adequate iron stores, the time to reach the target hematocrit is a function of the baseline hematocrit and the rate of hematocrit rise. The rate of increase in hematocrit is dependent upon the dose of ESA administered and individual variation. To ensure effective erythropoiesis, adequate iron stores must be continually maintained. Functional iron deficiency, with normal ferritin levels, but low transferrin saturation, is presumably due to the inability to mobilize iron stores rapidly enough to support increased erythropoiesis. The product labels note the iron status, including transferrin saturation and serum ferritin should be evaluated prior to initiation and during ESA therapy. Transferrin saturation should be at least 20% and ferritin should be at least 100 ng/mL. "Majority of patients with CKD will require supplemental iron during the course of ESA therapy" to adequately support erythropoiesis (Product Information Labels, 2013).
Methoxy Polyethylene Glycol - Epoetin Beta
In 2007, the FDA approved methoxy polyethylene glycol-epoetin beta (Mircera), an erythropoietin receptor activator to treat anemia associated with chronic renal failure for individuals in the U.S., including those on dialysis and individuals not on dialysis. The label also specifies epoetin beta is not indicated and not recommended: "(1) in the treatment of anemia due to cancer chemotherapy; (2) as a substitute for RBC transfusions in patients who require immediate correction of anemia" (Product Information, 2014). Epoetin beta was not commercially available in the U.S. until mid-2014. Methoxy polyethylene glycol-epoetin beta may be administered intravenously or subcutaneously once every 2 weeks or once a month to attain the hemoglobin target.
Chronic Kidney Disease
In 2006, the Correction of Hemoglobin and Outcomes in Renal insufficiency (CHOIR) trial published the results of an open label, randomized trial of 1432 individuals with chronic kidney disease. A total of 715 individuals were assigned to achieve a hemoglobin level of 13.5 g/dL and 717 individuals were assigned to achieve a level of 11.3 g/dL. A total of 222 composite events were recorded with 65 deaths (29.3%), 101 hospitalizations for congestive heart failure (CHF) (45.5%), 25 myocardial infarctions (MI) (11.3%) and 23 strokes (10.4%). The study was terminated early in May 2005 at the second interim analysis due to the results and other factors. The conclusion to this clinical trial was the use of 13.5 g/dL as a hemoglobin target as compared to 11.3 g/dL, was associated with increased risk and no improvement in the quality of life (Singh, 2006).
Drüeke and colleagues published the results of the Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE) trial in 2006. A total of 603 individuals with stage 3 or 4 chronic kidney disease were randomly assigned to different cohorts and observed for approximately 3 years. Individuals in cohort 1 were immediately treated with epoetin beta until a target hemoglobin level of 13-15.0 g/dL was achieved. Participants in cohort 2 initiated epoetin beta when the hemoglobin level fell below 10.5 g/dL and to maintain a hemoglobin level of 10.5-11.5 g/dL. The complete correction of anemia did not reduce the risk of cardiovascular events in either cohort. However, there was a higher prevalence of headaches and vascular disorders related to hypertensive episodes in cohort 1 (Drüeke, 2006).
Pfeffer (2009) reported results from the international randomized, double-blind, Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) comparing darbepoetin and placebo. The trial enrolled individuals with type 2 diabetes, chronic kidney disease and a hemoglobin level less than or equal to 11 g/dL. Of the evaluable 4038 individuals enrolled, 2012 were randomized to the darbepoetin alfa treatment group and 2026 were randomized to the placebo group. The study was completed in March 2009 with a median follow-up of 29.1 months. The overall median baseline hemoglobin was 10.4 g/dL. The median achieved hemoglobin was significant at 12.5 g/dL in the treatment group compared to 10.6 g/dL hemoglobin in the control group (p<0.001). The composite outcome of death or a nonfatal cardiovascular event was not statistically significant between the groups. However, "Fatal or nonfatal stroke was more likely to occur in the patients assigned to darbepoetin alfa (101 patients [5.0%] vs. 53 patients [2.6%]; hazard ratio, 1.92; 95% CI, 1.38 to 2.68; p<0.001)" (Pfeffer, 2009).
In the interim after the TREAT trial, the Anaemia Working Group of European Renal Best Practice (ERBP; Locatelli, 2010) provided suggestions for clinical practice prior to the Kidney Disease Improving Global Outcomes (KDIGO) international guideline update. Although the ERBP maintains "Hb values of 11-12 g/dL should be generally sought in the CKD population without intentionally exceeding 13 g/dL," the ERBP group suggested:
In patients with type 2 diabetes not undergoing dialysis (and probably in diabetics at all CKD stages), more caution is needed when treating anaemia with ESA therapy. In diabetic patients with a history of stroke, a lower target is more sensible (10-12 g/dL), balancing the risk-benefit of treatment and the desired Hb target in the individual patient. It is also of paramount importance to involve the patient in the decision making, and seek their personal views after a discussion about the benefits/risks of treatment.
In the KDIGO Anemia Work Group 2012 guideline update, the recommendations regarding initial and maintenance ESA therapy include "balancing the potential benefits of reducing blood transfusions and anemia-related symptoms against the risks of harm in individual patients (e.g., stroke, vascular access loss, and hypertension)." The Work Group recommends ESAs are not to be used to intentionally increase the hemoglobin above 13 g/dL. The guidelines also suggest for adults with CKD, ESAs should not be used to maintain hemoglobin above 11.5 g/dL.
The National Kidney Foundation (NKF) Work Group modified the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease in 2007. The NKF recommended hemoglobin target in individuals on dialysis and nondialysis should not be greater than 13 g/dL. However, based on the reported adverse events, the FDA Black Box Warning on the product information labels (2013) state individuals experienced greater risks for death, serious adverse cardiovascular reactions and stroke when administered ESAs to target a hemoglobin level of greater than 11 g/dL for individuals with CKD on dialysis. The labels also note no trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
Two large studies used observational data from the U.S. Renal Data System to compare two strategies of anemia management on individuals undergoing dialysis. The first study involved complex elderly individuals (participants at high risk for adverse cardiovascular outcomes) and the second study involved individuals with diabetes (Thamer, 2014; Zhang, 2014). The authors compared the low hematocrit (30%-34.5%) and the mid-range hematocrit (34.5%-39%) anemia management strategies from the database to emulate randomized clinical trials. Both studies found "Found no differences in the rates of mortality and a cardiovascular composite endpoint between these two clinical strategies, which supports the current FDA recommendations for a target hematocrit level up to 33% in hemodialysis patients."
Individuals with Chronic Renal Failure (CRF) Not Requiring Dialysis
Four clinical trials were conducted in individuals with CRF not on dialysis enrolling 181 individuals treated with epoetin for approximately 67 patient-years of experience. These participants responded to epoetin therapy in a manner similar to that observed in individuals on dialysis. Individuals with CRF not on dialysis demonstrated a dose-dependent and sustained increase in hematocrit when epoetin was administered by either an IV or SC route, with similar rates of rise of hematocrit when epoetin was administered by either route. Moreover, epoetin doses of 75 to 150 Units/kg per week have been shown to maintain hematocrits of 36% to 38% for up to 6 months. Based on the reported adverse events, the FDA Black Box Warning on the product information labels (2012) for epoetin and darbepoetin state:
Consider initiating ESA treatment only when the hemoglobin level is less than 10 g/dL. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of ESA, and use the lowest dose of ESA sufficient to reduce the need for RBC transfusions.
A randomized controlled trial for the correction of renal anemia in individuals with CKD (CORDATUS) study compared the use of monthly subcutaneous methoxy polyethylene glycol-epoetin beta versus weekly or biweekly subcutaneous darbepoetin alfa in individuals not on dialysis. The primary endpoint was hemoglobin response which was defined as a ≥ 1g/dL hemoglobin increase compared to baseline and hemoglobin ≥ 10 g/dL. Greater than 60% of the individuals treated with methoxy polyethylene glycol-epoetin beta had a response in increased hemoglobin and the responses were comparable to darbepoetin alfa (Roger, 2011).
Cancer Chemotherapy
Efficacy in individuals with anemia due to concomitant chemotherapy was demonstrated based on reduction in the requirement for RBC transfusions. ESA use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or wellbeing. ESAs are not indicated for use in individuals receiving hormonal agents, biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. According to the FDA product information, ESAs are not indicated for "patients receiving myelosuppressive therapy when the anticipated outcome is cure, due to the absence of studies that adequately characterize the impact of ESAs on progression-free and overall survival" (Product Information Labels, 2012). Data from clinical trials "Suggest that ESAs may promote tumor growth in an off-target manner. For this reason, these agents should not be used when the anticipated outcome is cure." Examples of cancers where there is therapy with curative intent include, but are not limited to early-stage breast cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, testicular cancer, early-stage non-small cell lung cancer (National Comprehensive Cancer Network® [NCCN®], 2014). In addition, the product labels (2012) include warnings of "Increased incidence of thromboembolic reactions, some serious and life-threatening, occurred in patients with cancer treated with ESA."
In 2010, the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) updated the clinical practice guidelines for the use of epoetin and darbepoetin in individuals with cancer. Guideline recommendations remind clinicians to carefully weigh the risks of thromboembolism in individuals for whom epoetin or darbepoetin is prescribed. Randomized clinical trials and systematic reviews demonstrate an increased risk of thromboembolism (Rizzo, 2010) in those treated with either epoetin or darbepoetin. ASCO/ASH recommend epoetin as a treatment option for individuals with chemotherapy associated anemia with a hemoglobin that is decreased to less than 10 g/dL to decrease transfusion. Depending on additional clinical and anemia circumstances, RBC transfusion is also an option (Rizzo, 2010). Epoetin can be titrated to achieve the lowest concentration or "appropriate hemoglobin level sufficient to avoid transfusion or the increase exceeds 1 g/dL in any 2-week period to avoid excessive ESA exposure" (Rizzo, 2010). The guidelines conclude the evidence from clinical trials supports the use of epoetin thrice weekly (150 U/kg/tiw) or 40,000 U weekly subcutaneously. With either dosing regimen, ASCO/ASH recommend that dose escalation be considered for those not responding to the initial dose. In the absence of response (for example, less than a 1 to 2 g/dL increase in hemoglobin), continuing beyond the 6-8 week treatment period does not appear to be beneficial (Rizzo, 2007; 2010).
The AHRQ review was updated with additional data from published studies and meta-analyses (Grant, 2013). The authors concluded the updated results were consistent with the 2006 review (Seidenfeld, 2006). The transfusion need was reduced with ESAs (pooled relative risk [RR] 0.58; 95% CI, 0.53 to 0.64: 38 trials), and the risk of thromboembolism was increased (pooled RR 1.41; 95% CI, 1.30 to 1.74; 37 trials). Fewer thromboembolic and on-study mortality adverse events were reported when delaying ESA treatment until hemoglobin was less than 10 g/dL at baseline. A total of 14 trials reporting the Functional Assessment of Cancer Therapy (FACT)-Fatigue scores had improved study participant-reported scores with ESA (increase by 2.1; 95% CI, -3.9 to 8.1) as compared to control arms (decrease by -0.6; 95% CI, -6.4 to 5.2). However, the authors concluded the magnitude of the FACT-Fatigue score difference "was less than the minimal clinically important difference. An increase in mortality accompanied the use of ESAs. An important unanswered question is whether dosing practices and overall ESA exposure might influence harms."
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines, 2015) recommend three general categories of asymptomatic and symptomatic clinical presentations in addition to hemoglobin levels for consideration of blood transfusions. ESA therapy is recommended for the prevention of transfusion in individuals with symptomatic anemia but the use of ESAs is not recommended beyond the treatment period where cancer-related therapies are provided. NCCN acknowledged the difficulties specifically defining the duration of chemotherapy-related anemia and defined a treatment period as following initiation of chemotherapy and continuing 6 weeks after the completion of chemotherapy. If no hemoglobin response is noted at 8 to 9 weeks, ESAs should be discontinued and RBC transfusion should be considered.
Hepatitis C Virus (HCV)
The combination of interferon (IFN) and ribavirin (RBV) has shown sustained virological responses (SVR) in individuals with HCV. Side effects of the combination treatment include anemia, which can be significant and may result in dose reduction or discontinuation of therapy. The IFN/RBV dose reduction has been associated with a decreased likelihood of early virological response (EVR) and sustained responses. In a randomized trial, 185 anemic individuals treated with combination therapy (IFN and RBV) for HCV were evaluated in 2 treatment phases (Afdhal, 2004). The first phase was 8 weeks long, double-blind, placebo-controlled comparing epoetin alfa versus placebo. The second phase was 8 weeks long, open-label, and allowed a modified crossover. The primary efficacy of RBV dosing at the end of the first phase was met with 88% of the study cohort treated with epoetin alfa maintaining the RBV dosing. The difference was significant as 60% (p<0.001) of the placebo group maintained the RBV dosing. The investigators reported quality of life (QOL) scores and hemoglobin levels were significantly improved for the epoetin treatment group versus the placebo group.
Dieterich and colleagues (2003) reported results of 64 individuals treated with RBV/IFN randomized to epoetin or standard of care (SOC). At week 16, the mean change for RBV dosing was -34 mg/day for the epoetin alfa cohort compared to -146 mg/day for the SOC group. At the completion of the 24 week study, 83% of the epoetin-alfa treatment group maintained RBV dosing compared to 54% of the participants receiving SOC. Hemoglobin levels were significantly higher (13.8 g/dL) in the treatment group versus 11.4 g/dL in the SOC group (p<0.0001).
In the 2011 American Association for the Study of Liver Diseases practice guideline update of genotype 1 chronic hepatitis C virus infection, it was noted that dose reduction of antiviral medications should be the initial response to manage anemia. However, it was noted that with longer duration of antiviral therapy, the frequency of anemia is likely to be greater. The potential benefits and risks must be weighed when considering the use of ESAs (Ghany, 2011).
HIV-infected, zidovudine-treated
Four placebo-controlled studies enrolling 297 individuals with hemoglobin less than 10 g/dL and HIV infection receiving concomitant therapy with zidovudine were included in the FDA approval analysis. In the subgroup of participants with pre-study endogenous serum erythropoietin levels ≤ 500 mUnits/mL, erythropoietin alfa reduced the mean cumulative number of units of blood transfused per participant by approximately 40% as compared to the placebo group. There was a statistically significant reduction (p<0.003) in RBC transfusion requirements in individuals treated with erythropoietin alfa compared to the placebo-treated cohort whose mean weekly zidovudine dose was ≤ 4200 mg/week. Approximately 17% of the participants in the treatment cohort with endogenous serum erythropoietin levels less than or equal to 500 mUnits/mL achieved a hemoglobin of 12.7 g/dL without administration of RBC transfusions or significant reduction in zidovudine dose. In the subgroup of participants in the treatment group whose pre-study endogenous serum erythropoietin levels were greater than 500 mUnits/mL, when compared to the corresponding placebo-treated participants, the erythropoietin alfa therapy did not reduce RBC transfusion requirements or increase hemoglobin (Product Information Label, 2012).
Myelodysplastic Syndrome
NCCN clinical guidelines (2014) recommend the use of epoetin and darbepoetin for the treatment of anemia in individuals with myelodysplastic syndrome (MDS) who have serum EPO levels ≤ 500 mU/mL, normal cytogenetics and < 15% marrow ringed sideroblasts. It was noted higher epoetin doses were required (40,000–60,000 units) one to three times a week subcutaneously. Darbepoetin doses were subcutaneous 150 to 300 mcg/kg/week with response rates in low risk individuals ranging from 40% to 60%. Clinical trial data suggested overall response rates from darbepoetin were similar to or higher compared to epoetin alfa.
Other Proposed Uses:
The American Hospital Formulary Services® (AHFS®, 2014) note that epoetin alfa "Has been used in a limited number of individuals with Gaucher's disease, Castleman's disease, anemia of prolonged acute renal failure, and in high dosages for the correction of ineffective hematopoiesis associated with paroxysmal nocturnal hemoglobinuria." However, further investigation is required to determine the safety and effectiveness of ESAs in these conditions.
Anemia of Prematurity
A 2006 Cochrane study addressed the early use of erythropoietin for preventing red blood cell transfusions in preterm or low birth weight infants (Ohlsson, 2006). A total of 2074 preterm infants enrolled in 23 studies were reviewed. The authors noted statistically significant heterogeneity in the studies. There were small reductions in the use of red blood cell transfusions, but the reductions were "of limited clinical importance." There was a significant increase in the risk of stage ≥ 3 retinopathy of prematurity (ROP) in the individuals treated with epoetin. A similar trend was noted in non-significant results for ROP of any stage. The authors concluded early administration of epoetin alfa in preterm infants was not recommended. In an updated review (Ohlsson, 2014), the conclusions remain unchanged, and epoetin is not recommended for routine use in preterm infants.
In another Cochrane review (Aher, 2006), two high quality, randomized, double-blind studies enrolled 262 infants and evaluated early versus late use of erythropoietin for preventing red blood cell transfusions in preterm infants. The authors concluded there was a non-significant reduction in the use of one or more units of blood transfusion or the number of transfused units per infant. There was a significant increase in the risk of stage ≥ 3 retinopathy of prematurity (ROP) in individuals treated with epoetin alfa.
The American Hospital Formulary Services (AHFS, 2014) note epoetin alfa appears it may be beneficial in the treatment of anemia of prematurity, but "optimal patient selection criteria remain to be more fully elucidated."
Heart Failure
Reduction of Events by Darbepoetin Alfa in Heart Failure [RED-HF] was an industry sponsored, phase III double-blind, controlled trial that randomized 2278 participants with mild-to-moderate anemia (hemoglobin level, 9.0 to 12.0 g per deciliter) and systolic heart failure to receive darbepoetin alfa or placebo to achieve a hemoglobin target of 13 g/dL. With a median follow-up of 28 months, the study was terminated on September 1, 2012. The primary composite outcome was death from any cause or hospitalization for worsening heart failure, which occurred in 50.7% (576 participants) of the darbepoetin alfa group and 49.5% (565 participants) in the placebo group (darbepoetin group hazard ratio 1.01; 95% CI, 0.90 to 1.13; p=0.87). Adverse thromboembolic events were reported in 13.5% (153 participants) in the darbepoetin treatment group versus 10.0% (114 participants) in the placebo group (p=0.01). The investigators concluded darbepoetin alfa therapy did not improve clinical outcomes in individuals with systolic heart failure and mild-to-moderate anemia (Swedberg, 2012).
In a clinical guideline for treatment of anemia in individuals with heart disease, the American College of Physicians provides a strong recommendation "…against the use of erythropoiesis-stimulating agents in patients with mild to moderate anemia and congestive heart failure or coronary heart disease" (Qaseem, 2013).
A Cochrane Review (Bath, 2013) of colony stimulating factors (CSF) for stroke included erythropoietin in addition to other CSFs. Functional outcome after an acute or subacute ischaemic or haemorrhagic stroke treated with CSF was the primary outcome. A total of 1275 participants in 11 randomized controlled trials were included in the analysis. Three trials involving erythropoietin treatment had a total of 782 participants. The authors concluded:
EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI), 1.19 to 3.3, p=0.009) and a non-significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume.
Traumatic Brain Injury
Talving and colleagues (2010) reported on a retrospective matched case control study of individuals who suffered severe traumatic brain injury (sTBI). A total of 89 individuals with sTBI who received ESA in the surgical intensive care unit were matched 1 to 2 to case controls (178 individuals). The primary outcome was mortality and secondary endpoints included acute respiratory distress syndrome, pneumonia, sepsis, acute renal failure, deep venous thrombosis and pulmonary embolism. Overall mortality was 18%; individuals treated with ESA experienced significantly lower in-hospital mortality compared to the controls (7.9% compared to 24.2%). There were no statistically significant differences in the secondary endpoints or in the transfusion requirements between the two study groups. However, there was a trend toward "increased complications, in particular renal failure and thromboembolic events noted in the ESA+ cases" (Talving, 2010). The authors concluded these results require validation through large randomized controlled trials.
Warnings and Adverse Events Darbepoetin and Epoetin Alfa (Product Information Labels, 2013)
Black Box warnings from the FDA Product Information Labels (2012) include the following:
Warnings: ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence.
Chronic Kidney Disease (darbepoetin, epoetin):
Cancer (darbepoetin and epoetin):
Perisurgery (epoetin): Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.
In two double-blind, placebo-controlled orthopedic studies, increased incidences of DVT were detected in individuals receiving epoetin alfa (11%) versus the placebo group (6%). The increased DVT rates were noted in the individuals with pretreatment hemoglobin greater than 13 g/dL (Product Information Labels, 2012).
Epoetin and darbepoetin have been associated with pure red cell aplasia (PRCA) and severe anemia, with or without cytopenias, associated with neutralizing antibodies to erythropoietin. The Product Information Labels for epoetin and darbepoetin warn, in the event of severe anemia and low reticulocyte count, individuals should be evaluated for causative factors which may include assays for binding and neutralizing antibodies. The manufacturers note, if antibody-mediated anemia is confirmed, then all recombinant erythropoietin products should be permanently discontinued as there is a potential for cross-reactivity with other erythropoietin. PRCA has been reported predominantly in individuals with chronic renal failure, but it has also been reported related to treatment for anemia and hepatitis C therapy (Product Information Labels, 2012).
ESAs are contraindicated in individuals with uncontrolled hypertension. ESA therapies may increase the risk of hypertensive encephalopathy, seizures, thrombotic and other serious events. Hypertension associated with rapid increases in hemoglobin (Hgb) has been rarely noted in individuals with cancer treated with ESA, but may occur. Hypertensive encephalopathy and seizures have been observed in individuals with chronic renal failure. Blood pressure should be monitored carefully, and hypertension should be aggressively controlled, particularly in individuals with an underlying history of hypertension or cardiovascular disease. During treatment, the Hgb should be monitored twice a week until it becomes stable. The dose of ESAs should be decreased if the Hgb increase exceeds 1 g/dL in any 2-week period or the Hgb exceeds recommended target. Higher risks of cardiovascular events may be associated with higher hemoglobin and/or higher rates of rise in the hemoglobin (Product Information Labels, 2012).
Warnings and Adverse Events Epoetin Beta (Product Information Labels, 2014)
Black Box warnings from the FDA Product Information Label (2014) include the following:
Chronic Kidney Disease:
Anemia: A condition of having too few red blood cells. Healthy red blood cells carry oxygen throughout the body. If the blood is low on red blood cells, the body does not get enough oxygen.
Biologic agent: Includes antibodies, interleukins and vaccines; a substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases.
Chronic kidney disease: Slow and progressive loss of kidney function over several years, often resulting in permanent kidney failure; may also be called chronic renal failure.
Endogenous: Originating from within the body.
End Stage Renal Disease (ESRD): Persistent decline in renal function as documented by falling creatinine clearance in an individual diagnosed with a renal disease whose natural history is progression to renal impairment requiring treatment to replace the work of the failed kidneys (for example, dialysis or transplant).
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information
Darbepoetin Alfa
Epoetin Alfa
Erythropoietin Stimulating Agents (ESA)
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Medical Policy & Technology Assessment Committee (MPTAC) review.
|Hematology/Oncology Subcommittee review. Updated Discussion/General Information, References and History sections. Updated Coding section with 01/01/2016 HCPCS changes; removed J0886 deleted 12/31/2015; also removed ICD-9 codes.
|MPTAC review. Updated Description, Discussion/General Information, Reference and Website sections.
|Updated Coding section with 01/01/2015 HCPCS changes; removed Q9972, Q9973 deleted 12/31/2014.
|MPTAC review. Added clinical indications for methoxy polyethylene glycol-epoetin beta (Mircera). Updated Discussion/General Information, References, Websites for Additional Information. Updated Coding section with 10/01/2014 HCPCS changes.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Clinical indications removed for peginesatide (Omontys) as the drug has been discontinued by the manufacturer.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Clarified criterion A and abbreviation in Clinical Indications. Added information regarding FDA recall for peginesatide. Updated Discussion/General Information, References, Websites for Additional Information.
|Updated Coding section with 01/01/2013 HCPCS changes; removed Q2047 deleted 12/31/2012.
|MPTAC review. Reformatted Position Statements and clarified hemoglobin levels in criteria. Added medically necessary indication for new FDA approved drug peginesatide. Updated Discussion/General Information, References, Websites for Additional Information, and Index. Updated Coding section with 07/01/2012 HCPCS changes.
|MPTAC review. Updated Clinical Indications for CKD to align with the updated FDA label. Reduced the hgb threshold for continued use. Discussion/General Information, References and Websites.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Updated Discussion/General Information, Coding, References and Websites.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Replaced "patient" with "individual" in clinical indications and reformatted CRF criteria for epoetin alfa and darbepoetin alfa. Clarified hypertension criteria. Updated Discussion/General Information to include FDA REMS program for oncologic indications. Updated coding, references and websites.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Formatting changes and clarification of Position Statements. Removed dosing tables and Place of Service. Updated Discussion/General Information. Updated references and websites.
|MPTAC review. Criteria revised in response to FDA warnings. Added not medically necessary criteria for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Clarified previous not medically necessary statement to include "hormonal agents, biologic products, or radiotherapy" unless receiving concomitant myelosuppressive chemotherapy. Added not medically necessary criteria for unlisted indications and for lack of response in cancer patients treated with chemotherapy. Updated coding section with 10/01/2008 ICD-9 changes.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Removed hematocrit criteria from medically necessary criteria. Updated references and websites.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Criteria revised in response to FDA warnings. Removed "biologic agents" from medical necessity statements. Added medically necessary indications with criteria for treatment of anemia in hepatitis C and chronic inflammatory diseases. Added Web Site section. Updated references and discussions/general information. Updated Coding section to include 01/01/2008 HCPCS changes.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Criteria clarified. Added definition section. Updated references and discussions/general information.
|MPTAC review.
|Hematology/Oncology Subcommittee review. Criteria revised in response to FDA warnings. Updated references and discussion/general information.
|MPTAC review. Medical necessity criteria revised to be congruent with FDA label for Hgb targets. Updated references and discussion/general information section.
|MPTAC annual review. Updated references and discussion/general information section. No change to guideline position. Coding updated; removed HCPCS J0880, Q0136, Q0137, Q4054, Q4055 deleted 12/31/05.
|MPTAC review. (Added black box warning).
|MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
|Pre-Merger Organizations
Last Review Date
Document Number
|Anthem, Inc.
|No document
|WellPoint Health Networks, Inc.
|Pharmacology Toolkit
(Procrit®, Epogen®, Epo)
|Pharmacology Toolkit
|Darbepoetin Alfa
|Clinical Guideline
(Procrit®, Epogen®, Epo)


text:
EAST LANSING — Michigan State calls Jairus Jones a weak-side "Star" linebacker.
Jones like to refer to himself as a "hybrid.''
Whatever the 6-foot-1, 215-pound Jones wants to call himself, he brings an element to the position that Spartans defensive mastermind Pat Narduzzi will use to the fullest advantage.
"In coverage, I can get to the ball,'' said Jones, who started the first six games at free safety last season before Kurtis Drummond assumed the position. "I'm good in the rundowns, too. I'm there to put more speed on the field.''
Narduzzi has praised Jones for his football I.Q. and play recognition, challenging the other candidates at the position — junior Taiwan Jones and redshirt sophomore Darien Harris — in the process.
Jairus Jones has embraced the position switch, as he's anxious to get on the football field.
"They tried it (position switch) a couple years ago, and I was a little immature and young and I was moping around like I didn't want to do it,' Jairus Jones said at Monday's media day. "Now, I'm a team guy, and I'm a little more mature. I don't mind it al all, it's all about playing, so I said, `OK, I'll try it out and show them what I can do.' ''
Jairus Jones shined in spring drills in his transition from safety to linebacker, and the chase for a starting spot has been on every since.
"I've been one of the more physical safeties,'' said Jones, who hails from Wharton High School in Tampa, Fla. "Not necessarily tackling-wise, but being able to get off blocks.
Even though I'm technically a linebacker, I call myself a hybrid.''
Jones said he believes his presence at the position should give the Spartans more versatility.
"I would just assume it's to give a different look for the different people we have to prepare for,'' Jones said. "I've been around this team for a while, so I know what everybody is supposed to do. It's little technique stuff now.''
Asked to compare himself to 6-foot-3, 250 pounds Taiwan Jones, who many considered the favorite to win the starting job going into spring drills, Jairus Jones indicated the differences are what one might expect.
"We both do the same things, he's just a little bit bigger, stronger,'' Jairus Jones said. "We're both fast, I'm a little quicker. I probably know the defense better, I'm in my final year.''
-- Download the MSU football on MLive app for iPhone and Android
-- Follow Diamond Leung and Mike Griffith on Twitter
-- Like MLive's Michigan State Spartans Facebook page.

subset: commoncrawl


text:
Product news: design studio Kawamura-Ganjavian has introduced a compact version of the Ostrich Pillow that only wraps around the eyes and ears. More »
Tag: product news
Ostrich Pillow Light by
DIY Lampshades
by Mostlikely
Product news: Austrian design collective Mostlikely has created a set of posters that can be cut up and folded into lampshades shaped like cartoon animal heads. More »
Stick-lets by
Christina Kazakia
Product news: these flexible silicone connecters have been designed by Christina Kazakia to help children to lash sticks together when building dens. More »
Kitchenware by Ole Jensen
for Room Copenhagen
Product news: a collection of kitchenware by Danish designer Ole Jensen is now in production with design brand Room Copenhagen. More »
Lulu lamp by
Jean-Sébastien Lagrange
Product news: industrial designer Jean-Sébastien Lagrange has created this lamp from interlocking sections of Tyvek. More »
Landscape daybed
by Outofstock
Product news: this daybed by design studio Outofstock is shaped to reference landscape elements (+ slideshow). More »
Swing Bar by
Duffy London
Product news: furniture brand Duffy London has surrounded this bar with swinging seats instead of stools. More »
Mini Jambox by
Product news: industrial designer Yves Behar has added a pocket-sized version to Jawbone's range of Jambox wireless speakers (+ slideshow). More »
Wine bottle by Zaha Hadid
for Leo Hillinger
Product news: London architect Zaha Hadid has designed a curvaceous wine bottle for Austrian winemaker Leo Hillinger. More »
A-Joint Table by Henry Wilson
for Very Good & Proper
Product news: British furniture brand Very Good & Proper has started producing this table by Australian designer Henry Wilson, which incorporates his trademark A-Joint. More »
Font Alphabet Puzzle
by Looodus
Product news: Milan company Looodus has designed a toy that allows children to learn about typography and the alphabet at the same time. More »
Scrapwood Wallpaper 2
by Piet Hein Eek for NLXL
Product news: Dutch designer Piet Hein Eek has produced a wallpaper collection that replicates weathered wood textures. More »
Swell sofa by Jonas Wagell
for Normann Copenhagen
Product news: Swedish designer Jonas Wagell has created a padded sofa that resembles the shape of risen bread. More »
Bola Service Table by
Antoni Pallejà Office
Product news: this ping pong table by Barcelona studio Antoni Pallejà Office has been pared down to look at home in a domestic interior (+ movie). More »
Bumper Bed by Marc Newson
for Domeau & Pérès
Product news: Australian designer Marc Newson has surrounded this bed for French brand Domeau & Pérès with chunky bumpers. More »
Tricom table by Shigeichiro Takeuchi
for COMMOC
Product news: this glass table by Japanese designer Shigeichiro Takeuchi balances on legs formed from a single steel pipe. More »
BLOWN lamp by Samuel Wilkinson
for &tradition
Product news: London designer Samuel Wilkinson has launched a blown-glass lamp with a digitally created lozenge pattern for Danish brand &tradition (+ movie). More »
Gergeti Coffee Table
by NVDRS
Product news: Milan design studio NVDRS has designed a coffee table with a removable wooden top that doubles as a tray. More »
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text:
Accessorize Makeup is too pretty for words. Really. I adore the butterfly overlay, and the quality of the product really is phenomenal considering the price.
Above are photos of the Merged Blush in Diva, a gorgeous bright pink softened by pearlescent veining that works beautifully on everyone.
The Merged Bronzer in Golden Sands is quite clearly, not a bronzer, but a soft shimmering pale gold highlighter, once again shot through with veining.
The colourpay off is exceptional, and not powdery. I've swatched both below, once.
These retail for around £5/£6 in Superdrug, and online at Accessorize.com
However if you are in the US/Canada and have access to Hard Candy cosmetics, you may want to have a closer look at them. I think you'll find distinct similarities . . . 😉


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Oh Susie...weeds is my middle name. Actually I like the idea of 'selective weeding'. There was someone on tv some time back who said she tended her beds in the manner of a grazing animal, chomping a bit off here and there with her hand. Has anyone tried that approach?
Following on the fridge magnets theme, the one I like is 'you can look at the dust but please don't write in it'
Thank you all for your really helpful comments.
Mulching sounds a good idea and keeping the lawn cut well and edged , yes every time. I'm in the process of training my husband on the edging. He hasn't quite got it yet....we've been together for 35 years but I live in hope.
I'm starting to wonder if one should actually go for opening ones garden. I confess to being reactive, not proactive (the genes I expect - blame my mother) so perhaps that's the answer. On the other hand, life's a bit too short to get fretting about a bit of bindweed....and nettle...and bramble...cleavers....ground ivy and all the rest
Oh dear,
I've spent the last few days going round gardens that are opening to the public.
How do folk manage to keep on top of the weeds and have everything looking so pristine? I've been told to tackle one bit of the garden at a time then work on the next. The trouble is if I turn my back for a day the weeds seem to be making a come back!
Apart from employing a gardener, which is out of the question for me, does anyone have any tips?
Well said Mike. Our group are as most a mixed bag. Some very knowledgeable, others complete beginners and most somewhere in the middle. We've had some very entertaining speakers who manage to appeal to all - a hard act to follow every time.
Onward and upward.
Thanks everyone. I should be up to speed for the next five years soon
I've been in touch with Carrie Thomas
It's a long way for her to come for one meeting. We meet on the last Thursday of each month. Carrie suggests there if there is another club in the West Midlands/South Staffs/ Worcestershire area that meets on the last Wed or Friday we might be in business. Is there anyone out there???
Thanks Dovefromabove.
I looked at her site and would be very interested. I think Swansea may be too far away (we're in South Staffs) but I will contact her to check.
Thanks again,
Thanks Nutcutlet, you've given me some good pointers there.
I sorted out my red ants this week. Digging with my spade at arms length - so that they didn't invade my private spaces - I dug out the nest, put it in one of those big bucket things and chucked them all in the canal (I'm lucky to have one at the bottom of my garden)... and so the circle of life continues. There were lots of fish ripples around for some time. If you don't have a canal handy a bucket of water might do the trick!
I used to design and make decorative fountains and have a bubble fountain operating on a solar panel that has been in the garden for nearly nine years without problems. I used to hear all sorts of complaints about SP pumps breaking down but these always turned out to be cheap Far Eastern imports.
Solar pumps are great if you choose the right one. The variation in flow as a result of changing light levels is fascinating but can cause problems if they are used in the wrong water feature eg a spouting mask may become a dribbling one when the sun goes behind a cloud. The water may well then just drp down the wall and empty the catch bowl. The opposite can also happen and strong light can cause a spouting fountain to spout too fiercely and ditto - an empty container.
If you do go for solar choose carefully, get expert advice and be prepared to buy the best. My old one is an Oase one and it has been brilliant.
Thanks everyone for such a variety of responses to this problem.
I don't think anyone has mentioned the pain that can be inflicted by red ants. I was happily weeding a flower border last week when I felt a sharp pain, like a thorn under my tshirt. It was a red ant. Unknown to me I had another lurking that went on to sting elsewhere. These lumps lasted almost a week and were intensely itchy. Maybe I'm over sensitive but they were no joke. I'd hate our young grandchildren to be attacked.
I have put out bait stations but can't see where the nest is - under a big plant I guess. Does anyone know if nematodes work if you can't water them directly onto the nest?


text:
Top Definition
Tida is a Hawaiian word for an agressive female personality who will fight with you. Very similar to Tita, only spelled phonetically like a Haole with a mainland education would spell it.
Shakespeare proved to us that he could tame a shrew, but Eslynne Smith will prove to you that you do not tame a Tida, the Tida tames you.
от TamingTheTida 01 февруари 2015
Trending Now
Can you define these popular missing words?
1. Often associated with speed and agility, a Tida is best described in one word: Steeze. Rare among third world countries due to hazzardous circumstances, Tidas strive in warm climates and river-side habitats. 2. Tom Schaaf 3. The butt-end of a pool stick. Rarely recognized as a piece in itself, it is detachable from a pool stick and can be used in self defense against angry, drunken, and often fairy-boyesque opponents.
In a state of shock and confusion, I gently detached my tida from my pool stick and threw it at Bob.
от Tom Schaaf 27 септември 2005
good at sucking dick. likes to suck it. and sucked alot.
a natural pro.
a natural pro.
I wish i had a tida to suck my dick.
от helloimbored 03 юни 2009
a druggie.
your such a tida
от helloimbored 03 юни 2009
The white freckley thing with a funny nose
That is so totally Tida
от Rachellie 21 февруари 2007


text:
You may enjoy heightened intellectual clarity today, which could help you make wiser decisions. Since mental clarity and intuitive awareness can work well together, you may want to spend some time strengthening your intuition to aid you in resolving dilemmas, overcoming obstacles, or even creating more fulfilling life circumstances. One good way to heighten your intuitive abilities is by spending quiet time alone in meditation. Simply set aside a period of time to be alone today. Cut out all distractions, and allow yourself to become very relaxed. Then turn your attention to your spiritual center and imagine connecting with the divine wisdom that lies within you. Feel your awareness expand and your senses awaken. Then simply recall this mind-set during any situation where you might be in need of guidance.
Awakening our intuitive insight can help us live our lives more consciously and make decisions that reflect our long-term objectives. While logic and mental agility are important factors in making beneficial decisions, we often forget that our intuition can also be an invaluable tool. By tapping into the divine wisdom within us, we are alerted to possible problems that we may not have been aware of on a conscious level, and we are able to sense intuitively the choices that would be best for us. With this heightened awareness, we are able to make wiser decisions and live more fulfilling lives. Combining your sharp intellectual focus with a deeper connection to your inner wisdom can make your decisions seem clear and simple today.
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text:
The FDA has approved Merck's (NYSE: MRK ) Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women, a condition that Merck says affects more than 20 million American women.
Overactive bladder is characterized by a strong urge to urinate right away and the need to urinate more often. It typically affects women between the ages of 45 and 60.
Oxytrol was previously a prescription-only patch, but Merck convinced the FDA that it was safe enough for over-the-counter status. The company ran a series of studies to prove that women could correctly diagnose that they have overactive bladder and that they could use the patch correctly unsupervised.
Merck licensed Oxytrol as an over-the-counter treatment for overactive bladder from Watson Pharmaceuticals, now known as Actavis (NYSE: AGN ) . Oxytrol will remain as a prescription drug for the treatment of overactive bladder in men.


text:
If you haven't yet, be sure to "like" Chew On It: Beard vs. Food on Facebook and follow me on Twitter!
I have only been to McGarrey's Oakwood Cafe one other time, to try their soup. It was suggested to me to go back this round and try some of their comfort-style food. This Erie favorite got the most votes this week by leaps and bounds, so Amanda and I headed there on Monday night. There were only a few tables of people seated when we arrived so we had our choice of seats. We took a few minutes to look over the menu and after talking it over with each other, as well as asking our server for some recommendations, we were ready for dinner.
Amanda settled on the pot roast. A cold winter's night, slow cooked roast beef, and hot mashed potatoes fits the definition of comfort food quite well. The beef slices were piled high on the plate and smothered in thick, brown gravy. To our dismay, however, some of the meat looked pretty unappetizing. Many of the slices were mostly fat, which is characteristic of pot roast, but was still disappointing. In addition, some of the meat had started to turn from brown to a not-so-appetizing shade of iridescent yellow. Upon further investigation when we got home, we discovered that the meat would have been safe to eat. However, if food doesn't look appetizing, it's human nature to not want to eat it. The roast came with a choice of potato and a tossed salad or the vegetable of the day- corn. Amanda chose mashed potatoes and the corn. The potatoes were good, but not as good as the homemade potatoes from last week and the corn overcooked and tough. Although I typically do not like gravy, the slices of beef we ate, as well as the potatoes, were good with the gravy.
Growing up with and Italian grandma and a Ukranian grandpa, I ate more than my fair share of stuffed cabbage rolls. My Nana and my dad made them regularly and they became one of my childhood favorites. When I saw them on the menu, I had to try them. Two good-sized rolls were topped with the house marinara sauce and were served with my choice of potato, I chose mashed, and a salad. The salad was pretty standard, an iceberg lettuce blend with tomatoes, and the Italian dressing was good. The cabbage was stuffed with a seasoned beef and rice mixture. I have never had marinara sauce on top of cabbage rolls, nor have I had them with mashed potatoes, so it was different from what I'm used to, but not bad. The stuffed cabbage rolls obviously weren't my dad's or Nana's, but seeing as how I haven't found them on another menu in Erie, these served as an acceptable substitute.
The meal wasn't the best when it comes to comfort food, but they did have speed of service and price on their side. Our food was out fast and our bill was under $18 before tip. The menu is stacked heavily with sandwiches so that might be a better choice over the comfort food. The phone number is (814) 866-0552 and the business hours are Monday through Saturday from 11:00 am – 10:00 pm and Sunday from 11:00 am – 8:00 pm.
Keep sending me your recommendations for local favorite comfort foods to email@example.com or to the Beard Vs. Food Facebook. Remember to come back and vote as well.
Until next time,
Andrew – Beard vs. Food


text:
Katy Perry and an 11-Year-Old Autistic Girl Will Make You Cry Your Whole Face OffJulianna Miner
Usually, I just write about things that are funny. This video is not funny, and I should warn you that it made me ugly cry so hard that my kids looked alarmed as terrifying black mascara tears rained down my face. But it's the best 8 minutes and 34 seconds you'll spend on the internet all day, I promise.
The video features a performance from Comedy Central's "Night of Too Many Stars: America Comes Together for Autism Programs". The event was hosted by Jon Stewart and is raising money for autism programs, schools, and services all over the US.
The clip shows an amazing 11-year-old girl, Jodi Piazza, who was diagnosed with Autism at the age of 2. As you see in the video, Jodi was able to benefit from the kinds of programs, schools and therapies the "Night of Too Many Stars" is hoping to help. She's singing here with Katy Perry and together they sound just… amazing.
You go, Jodi. You're so [gulp, muffled sob] beautiful and talented! And you go, Jodi's parents! I'm hugging you right now from far away, and it's starting to get awkward because I don't want to let go because I love you.
AND DAMN YOU, KATY PERRY. You are not supposed to make me cry. But you're awesome right now, so I forgive you.
"Night of Too Many Stars" airs Sunday, October 21 at 8/7c on Comedy Central.
Please join me here once a week for more Rants in My Pants. You can also find me at Rants from Mommyland, on Facebook, Twitter and Pinterest.


text:
Top Definition
A free 10 minutes to do whatever you want while your teacher attempts to make the smartboard work. Often happens to dyslexic and long haired blonde science teachers.
Oh she's trying to turn on the smart board auto10! I can check my email now.
by lololololololololol April 11, 2008
Trending Now
Can you define these popular missing words?


text:
UNECA Holds First Climate Change and Development Conference in Africa
19 October 2011: The First Climate Change and Development in Africa Conference convened under the theme "Development First: Addressing climate change in Africa." The event sought to address the need for greatly improved climate data and information for Africa, in addition to strengthening the use of this information for policy and decision making.
Organized by the UN Economic Commission for Africa's (UNECA) African Climate Policy Centre (ACPC), the conference highlighted the need for adaptation as the primary strategy to address the effects of climate change.
It aimed to provide a platform for: deliberating improved data and climate change governance; mainstreaming climate change into development; harnessing research and innovation for climate change; and promoting regional and international cooperation and partnerships in climate.
Abdoulie Janneh, Executive Secretary, UNECA, noted that adaptation offers an opportunity to manage risk and enhance choices, thereby contributing to sustainable development and addressing the social, economic and security threats posed by climate change.
Discussions at the conference also addressed economics and finance of climate change and low carbon development in Africa. Erastus Mwencha, Deputy Chairperson, African Union Commission (AUC), in his address, noted that a "green economy" can be achieved, but requires genuine commitment by the international community. The Conference took place from 17-19 October 2011, in Addis Ababa, Ethiopia. [UNECA Press Release] [UN Press Release] [Statement by Erastus Mwencha]


text:
PASSAGES: Brandy Has A Baby Girl
BORN: R&B star Brandy, 23, and her husband, Robert Smith, welcomed their first child, a baby girl, on Tuesday, the singer's representative at Atlantic Records, Lou Rizzo, confirmed in an e-mail to radio stations. The baby is named Sy'rai, it was revealed on Brandy's official Web site on Wednesday, and she was born on Father's Day. . . . SECURED: "The Scorpion King" star The Rock (real name: Dwayne Johnson), 30, has made a deal to play Hawaii's most famous warrior-king, Kamehameha the Great, in an upcoming feature film about the ruler, to be produced by Sony Pictures, says Variety, which adds that the company hopes the film will turn out to be the Polynesian "Braveheart." Tuesday's PEOPLE.com reported that The Rock seriously wanted the role. . . . DIED: Revered St. Louis sports broadcaster Jack Buck, 77, died Tuesday night after a long hospital stay, reports the AP. "He didn't waste one minute of one day," his son, fellow announcer Jack Buck, told the news service. "He packed two lifetimes into one lifetime. He went from poor to wealthy in his lifetime, yet he never changed." Also, distinguished museum director J. Carter Brown, 67, who among his many accomplishments helped develop a host of monuments -- including the Vietnam Memorial -- in Washington, D.C., died Monday in a Boston hospital after a six-week battle with a blood cancer, his family said in a statement. In a front-page obituary on Wednesday, The New York Times said Brown transformed the art-museum world in the latter half of the 20th century . . . SOLD: Three landscape watercolors painted by England's Prince Charles, 53, fetched around $10,000 each at an auction Tuesday, reports the Associated Press. Auctioneers Fellows & Sons in Birmingham told the news service that nearly 100 people vied for the works, with collectors and dealers from North America making telephone bids. No word on how Charles will spend the money.


text:
PRESEASON: Cowboys 3, Raiders 0
Photo: Michael Ainsworth/Staff Photographer
Dallas Cowboys quarterback Tony Romo (9) leaves the field after warming up prior to their preseason game in Oakland, CA, on Monday, August 13, 2012.
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text:
Vigil marks plight of abused children
By Becky Barclay
Published in News on February 29, 2012 1:46 PM
Full Size
News-Argus/ALLISON CARTER
Jessica Troquille lights candles Tuesday at the Life L.I.G.H.T.S event in remembrance of children who have lost their lives due to child abuse or neglect.
Several flames burned brightly for 17 tiny lives lost too early, while 600 small candles flickered for the children who are still victims of abuse and neglect during a candlelight vigil held Tuesday at Berkeley Mall. Sponsored by the WAGES/Wayne...
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text:
Lopez arrived without her husband Marc Anthony, instead bringing her mother, Guadalupe, who got to mingle with the Duke and Duchess of Cambridge at the hottest Hollywood event of the summer.
A week later, Lopez and Anthony told PEOPLE that they made a "very difficult decision" to "end our marriage" after seven years. The couple have 3-year-old twins.
Although Anthony's absence raised eyebrows at the BAFTA event, it turns out this wasn't the first time he was missing in action. The pair had not been seen together since early June, with Lopez traveling to Europe and later to Disneyland with their children, but not Anthony.
Power CoupleAnthony's no-shows fueled rumors of trouble in their marriage, even if Anthony did have reason to be away: he's been busy this summer filming the TNT medical drama HawthoRNe, in which he plays a police detective
Also, with Anthony and Lopez, Hollywood observers have long been wary of jumping to conclusions since catching people off-guard has been their hallmark from the very beginning.
They were married in secret in June 2004 at Lopez's Beverly Hills home.
At the time, the two had never even acknowledged their romantic relationship publicly, and, days before, Anthony had been granted a divorce in the Dominican Republic from Dayanara Torres, with whom he has two sons.
The marriage was the third for Lopez, and it came just months after her whirlwind 18-month-relationship with – and engagement to – Ben Affleck.
Lopez and Anthony went on to become one of show business's closest and most successful power couples. They were fixtures at award shows, premieres and fundraisers, famously toured together and, in February 2008, welcomed twins son Max and daughter Emme.
As late as last May, they still seemed very much together in business and in love.
Anthony doted on his wife on May 9 as she celebrated the release of her new album, Love? in Hollywood. Anthony "melted every time she acknowledged him," an observer said.
They turned out together on May 23 at a ceremony honoring TV producer Simon Fuller with a new star on the Hollywood Walk of Fame, then performed together and kissed affectionately at the May 25 finale of American Idol, which Lopez joined as a judge last season.
The following week, they announced another business venture together: the globetrotting reality show, ¡Q'Viva! The Chosen to find the "world's most extraordinary talent."
Trouble SignsBut just days later, the first hint of trouble emerged. The couple appeared at the Samsung Hope for Children Gala in New York on June 7, and many photos showed Lopez without her usual radiant smile.
This would be their last event together before the split announcement.
Afterwards, Lopez , her mother and the twins traveled to France and Spain as the singer participated in a French reality TV show. Then on June 25, Lopez, her mother and the children were spotted at Disneyland in Anaheim, Calif., going on the Dumbo ride and attracting large crowds of curious guests.
Anthony was nowhere to be seen.


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Originally posted on Fox Sports Arizona | Last updated 12/18/11
GLENDALE, Ariz. -- John Skelton needs a signature move so fans can officially say they are Skelton-ing. Either that or we could all just take a deep breath. It might help us think more rationally than the folks living in mile-high thin air. On a day when Denvers touchdown Jesus, Tim Tebow, came back to earth with a mortal thud against the Patriots, Skelton upped his season record to 5-1, helping the Cardinals became just the second NFL team to win three overtime games at home in a season by beating the Cleveland Browns 20-17 at University of Phoenix Stadium. The Cardinals backup quarterback wasnt always pretty. He wasnt always good. But he completed 28 of 46 attempts for 313 yards, and his 32-yard completion to receiver Larry Fitzgerald in overtime set up Jay Feelys 22-yard field goal for the Cards sixth win in their last seven games. Dont let Jay tell you hes the big hero now, cracked coach Ken Whisenhunt, whose team has reached the .500 mark with its first four-game winning streak in Whisenhunts tenure. All he had to do was kick an extra point. Whisenhunt wont have to worry. After the game, nobody was focused on Feelys two clutch kicks. Nobody asked about Whisenhunts 43rd victory as Arizonas coach, which gave him the franchises all-time victories record. And when the media relations staff announced that Skelton was headed to the interview room, linebacker Paris Lenon noted (with a smile) how many reporters bailed on an interview with linebacker OBrien Schofield, whose sack and forced fumble set up Feelys game-tying field goal with 5:40 left in regulation. Everybody loves the quarterback, Lenon said. Skelton was all the rage in the postgame press conference for his Tebow-esque late-game heroics. Whoever coined the term Tebow-esque should probably trademark it, Skelton said. I want to make my own legacy. Id prefer Skelton-esque. You might read elsewhere today about a certain vibe Skelton has created with this 5-1 run. But before you lose touch with reality like the folks in Denver, you should know Skelton doesnt put much credence in that notion. Not at all, he said. I dont think it ever comes down to one individual on a team. Our defense has been playing that much better the past few weeks, and our offense, when it needs to, finds a way to get it done. Its never about one guy. That may not be the sexy story today, but its the truth. We had so many different guys make plays throughout the course of the game, especially in the second half, Whisenhunt said. The way our team fights back is really something special. The biggest plays of the game, mostly due to timing, were Schofields sack and forced fumble -- which defensive end Calais Campbell recovered -- along with Patrick Petersons 32-yard punt return in overtime and Fitzgeralds catch. But the Cards also got six catches from receiver Andre Roberts, eight tackles and a pass defended by safety Adrian Wilson and some critical completions by Skelton. About the only thing that didnt go right for the Cards other than struggling for most of the game against a woeful opponent was the Detroit Lions late rally for a 28-27 win at Oakland. Had the Lions lost, the Cards would have pulled within a game of a wild-card spot with two to play. Instead, Arizona faces extremely long odds to the postseason, needing to win out while either the Lions or Falcons lose twice and the Bears, Cowboys and Giants also provide help. It would have been the perfect ending to this Sunday script had Oakland kicker Sebastian Janikowski nailed a lengthy last-second field goal to beat Detroit. But the Cards may have to settle for progress and momentum heading into next season. We would like to go to the playoffs, but all we can control is what we can control, and thats just to keep winning, Schofield said. Hopefully something good will happen for us -- in the offseason or the postseason.
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As many of you are probably aware, automatic budget cuts from sequestration took effect last Friday.
Programs funded through the U.S. Department of Education will be cut by about 5.3 percent, according to the Government Accountability Office. The cuts aren't just for this year, either. They're aimed at chopping $1.5 trillion out of the federal deficit over the next decade. So, if nothing happens, they're the new normal. U.S. Secretary of Education Arne Duncan explains the impact.
Districts around the state are feeling the impact as well. Here's a list of sequestration cuts by district in New York state. [PDF compiled by NYSSBA] The districts are compiled by county, without heading, so you may have to scroll a bit to find your district.
Education Week has also put together a list of 12 FAQ's that help to clarify the impact of the cuts.
Do these all of these cuts to schools make you want to do something? The New York State Council of School Superintendents (NYSCOSS) has put together a great advocacy tool for sequestration. You can enter your zip code and boom, all of your federal representatives are made available for you to email them all at once.


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Toddler Packing 101marylweimer
Remember what it was like to go on vacation in your pre-parenthood days? When all you had to do was throw a teeny-weeny bikini and some flip flops in a bag and you were good to go?
Irony #1568 of parenting: when you need a vacation more than ever before, preparing for a vacation becomes harder than ever.
There's a lot to remember when packing for a family. In our family of five, preparing for a week —or even a weekend— away takes a huge amount of preparation.
I thought I'd share a few tips that I've learned to help ease the inevitable pre-vacation stress.
1. Less is More
We're minimalists when it comes to packing. For our upcoming nine day trip, I'm packing the following for each child: 4 everyday outfits, 2 dressier outfits, 2 swimsuits, and 2 pairs of pajamas. Since it's summer we're able to get away with one pair of shoes for each of the boys and 2 pairs for my daughter. (I'm planning on a laundry day mid-trip.)
The bottom line is this: develop a check list that works for your family and your vacation destination, and try to avoid bring extra items. After all, you're trying to make memories, not a fashion statement!
2. Pack Each Outfit with Accessories in a Ziploc Slider Bag
A vacation is so much easier when the kiddos can just get out of bed and dress themselves. That's why I use individual Ziploc bags for each of my children's outfits. There are two benefits to packing in this way: you're less likely to forget something and it makes dressing easier on hectic travel days. Dirty clothes can go right back in the bags, which prevents the mixing with clean items.
3. Think about Carseats, Strollers and Travel Beds. What Will Work Best?
Are you flying to your destination? The FAA recommends that toddlers use a Child Restraint System during the flight. If you're checking a car seat you should consider wrapping it in protective plastic or bubble wrap, placing it in a clear garbage bag, and writing your contact information on a label affixed to the bag. You can also gate-check strollers. Another consideration, though, is to rent these items through a service such as Baby's Away or a local vendor.
4. WWYTP: What Would Your Toddler Pack?
Think sippy cups, special pillows, snacks, or any DVDs they're currently obsessed with. What would be on your toddler's must-pack list? On our list: a bag filled with crayons, coloring books, special toys, our iPad, and her blankie.
Packing for your toddler does take additional planning, but the memories you create will make it all worth it. As for me, I'd trade family memories for having a teeny-weeny bikini body any day.
Mary Lauren Weimer is a social worker turned mother turned writer. Her blog, My 3 Little Birds, encourages moms to put down the baby books for a moment and tell their own stories. Connect with her on Facebook and Twitter.
More by Mary Lauren:
Ten Truths about Toddlers: What Parents Should Know
Potty Training Tips from the Experts: Moms!
Why I Was a Better Parent Before I Had Kids
A big thanks to Ziploc for sponsoring this campaign. Click here to see more of the discussion.


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"What is geriatrics?" is a question of increasing insistence.
Dr. Stieglitz is a pioneer and a leader in geriatrics. He was associate clinical professor at Rush Medical College, was the first consultant on gerontology in the United States Public Health Service and now is in active practice in and about Washington, D. C.
The first edition of this book, published in 1943, laid down foundations, stated principles and made a comprehensive presentation of clinical subjects designed to aid the physician in his daily work. This second edition, edited by Stieglitz and written by himself and forty-six others, has preserved the outstanding essentials of the first and has added new features which further explain, stimulate and inform. The most significant change is in the subtitle, in which Dr. Stieglitz broadens the term geriatric medicine, interpreting it as the "Care of the Aging and the Aged." Thus he emphasizes that medical care
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Whichever sweet pea seeds you choose to sow, your garden will be filled with masses of fragrant blooms that make perfect cut flowers. In fact, cutting sweet peas more often means that you'll get an almost never-ending supply of summer flowers! We've got some great advice for getting the best out of your sweet pea seeds - read our How to Grow Sweet Peas guide or watch our sowing and growing sweet peas video.
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Sweet Pea 'Flying the Flag'
Lathyrus odoratus, Grandiflora Sweet Pea
This impressive collection comprises three specially selected heirloom (Grandiflora) varieties for their patriotic colours and superb fragrance. These colourful small flowered types make a bright display of national pride trained against fences or over obelisks in flower borders. Height: 180cm (71"). Spread: 30cm (12").
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Sweet Pea 'Blue Velvet'
Lathyrus odoratusIntriguing deep purple-blue flowers that are so dark they almost appear to shimmer black in the summer sunshine. The large, fragrant blooms, set atop particularly long stems, make an astonishing exhibit for the show bench and are equally eye catching in flower borders. Sweet Pea 'Blue Velvet' is a free flowering variety producing 4 or five blooms per stem. Height: 180cm (71") Spread: 30cm (12").
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Hi! I'm Ramon Bispo (a.k.a. RamonPage), a full stack developer, visual/graphic designer, and rapper from Rio de Janeiro, Brazil.
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Currently, I'm Co-founder at KredStreet — the company behind SmogFarm and PsychSignal — and Front-end Developer at Xamarin.
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Turn on some music... I got my music...
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On Wednesday, Kim Kardashian, Kanye West and daughter North stepped out for some family time at Hakkasan Beverly Hills.
After West's much buzzed-about appearance on Jimmy Kimmel Live, the trio indulged in the restaurant's Cantonese cuisine, specifically the crispy duck salad, jasmine tea smoked pork short ribs, the steamed dim sum platter, sanpei corn-fed chicken claypot, grilled sea bass with Chinese honey and Hakka noodles with mushroom and Chinese chive.
But even with all that food, North – whom the couple affectionately calls Nori – was the main attraction.
"Their attention was very much centered on the baby," an onlooker tells PEOPLE. "They were in an upbeat mood and seemed to be very happy and hungry!"
Kardashian sipped on jasmine tea and was "very openly affectionate with North," the source adds.
This Jimmy Kimmel interview is the truth!— Kim Kardashian (@KimKardashian) October 10, 2013
– Raha Lewis
Spot a celebrity? Tweet us your sighting— People magazine (@peoplemag) August 7, 2012
@peoplemag with #CITA and it could appear on PEOPLE.com!


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Target unveils year-round online price match
NEW YORK -- Target Corp. said today that its pledge to match prices of select online rivals this past holiday season is now a year-round promise.
The nation's second largest discounter behind Wal-Mart Stores Inc. said it will match prices that customers find on identical products at top online retailers, all the time. The online list includes Amazon.com as well as the websites of Wal-Mart, Best Buy, Toys R Us and Babies R Us.
Target's holiday price match program with online retailers began Nov. 1 and ended Dec. 16. Target is also making permanent its holiday offer of matching prices of items found at its stores with those on its website. And for the first time it will include products that are out of stock on Target.com
The moves follow a disappointing holiday shopping season for the Minneapolis-based retailer, hurt by stiffer competition from online rivals and stores like Wal-Mart that have hammered its low prices. It's also the latest step from brick-and-mortar stores to combat "showrooming" -- a growing trend for customers to browse their stores to check out products, and then go online to buy the same products for less elsewhere.
Mark Schindele, Target senior vice president of merchandising operations, noted the discounter monitors prices of 30,000 items, and thousands more online, to make sure it's competitive. But Target says it had to do more to give shoppers more confidence.
"We believe that our prices are competitive year round," Schindele said in an interview. "We also know that our guests shop in many ways."
Many major stores have offered price matching guarantees for local competitors' brick-and-mortar stores, but it wasn't until this past holiday season that the focus was on matching online prices. That can be difficult, since online prices tend to be lower and fluctuate often.
Best Buy is matching prices with 20 online retailers on electronics and appliances at its physical stores through Jan. 31. Best Buy spokeswoman Amy von Walter declined to "speculate" on whether it would make that plan permanent.
Since last summer Toys R Us has been matching online prices for all identical items or models of baby gear merchandise from selected national competitors like walmart.com, target.com, sears.com, Amazon, buybuybaby.com and diapers.com. Like Target's policy, it excludes Amazon's third party Marketplace items.
Wal-Mart has trumpeted its low price message but stopped short of matching prices with online rivals.


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[VIDEO] The Dewey Bozella Story (ESPN)
Not sure if anybody has gotten an opportunity to peep this, so I decided to post it here. ESPN chronicling the life story of boxer Dewey Bozella who was convicted of a crime he didn't committ in the 80s and sent to Sing Sing Prison, and working his way into his first professional fight.
I got the opportunity to meet this brother not too long ago, his story is crazy inspiring. Hope you guys enjoy and maybe we can get a discussion going, be blessed
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No matter what kind of celebration you have in mind, Shindigz colorful India banners announce the event with beauty. Choose vertical or horizontal placements. All designs come in vinyl, which is perfect for outdoors, or peel-and-stick versions suitable for interior walls. Add color-coordinated party supplies and decorations to bring the celebration together. Create an authentic feel with our Taj Mahal party table items. The vibrant colors and exotic touches will transform the party room and mesmerize your guests. If you plan on serving Indian cuisine at your gathering, Shindigz decorations and party supplies are sure to enhance the ethnicity factor.
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Home living
Gorgeous real alpaca fur hot water bottle covers, alpaca knitted hot water bottle covers and slouchy matching bed socks are just a few of the items we stock here at Perilla Towers (sorry that should be Barn!). We also have an eclectic mix of other goodies such as slippers and hot water bottles to exotic cashmere blankets and throws. Our ethos is all about cosy warmth and how to attain it as well as trying to give a little inspiration for the gift weary! We can gift box anything and everything and are pretty good at doing as we are asked - just call us!


text: It has been seven years since Morrissey's last studio disc, 1997's Maladjusted, but, heaven knows, he's still miserable. Which is cause for Moz fans everywhere to rejoice with this smashing comeback effort. Sounding refocused and recommitted, the British pop icon, 45, makes a CD that ranks with his best post-Smiths solo work. Hunt this Quarry down now. Brimming with his trademark biting wit and melancholy melodies, songs like "The World Is Full of Crashing Bores," "How Can Anybody Possibly Know How I Feel?" and "All the Lazy Dykes" live up to their classic Morrissey titles. Best are the bloody brilliant "I Have Forgiven Jesus" ("For all the desire/ He placed in me when there's nothing I can do with this desire") and the vintage-Smiths jangle-rocker "Let Me Kiss You," on which, in typical self-deprecating fashion, Morrissey asks a would-be lover to "close your eyes and think of someone you physically admire." He closes things with the ironic "You Know I Couldn't Last," fully aware that he has had the last laugh on "the critics who can't break you/ Unwittingly, they make you."