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document
Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding : a randomized , controlled trial . 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 randomized , 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 .
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Intervention_Pharmacological
ferric carboxymaltose injection
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Intervention_Pharmacological
large-dose intravenous ( IV ) administration of ferric carboxymaltose
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Intervention_Pharmacological
oral iron
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Intervention_Pharmacological
IV ferric carboxymaltose
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Intervention_Pharmacological
of ferrous sulfate
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Intervention_Pharmacological
ferrous sulfate
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Intervention_Pharmacological
ferric carboxymaltose
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Intervention_Pharmacological
ferric carboxymaltose
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Intervention_Pharmacological
ferrous sulfate
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Intervention_Pharmacological
new iron agent , ferric carboxymaltose
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Intervention_Pharmacological
oral iron therapy
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Outcome_Physical
hemoglobin ( Hb )
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Outcome_Physical
correction
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Outcome_Physical
vitality and physical function
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Outcome_Physical
greater improvement in symptoms of fatigue
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Outcome_Adverse-effects
serious adverse drug events
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Outcome_Physical
correcting anemia
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Outcome_Physical
replenishing iron stores
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Outcome_Other
improving quality of life
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Participant_Condition
anemia
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Participant_Condition
uterine bleeding
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Participant_Sample-size
477
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Participant_Sex
women
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Participant_Condition
anemia , iron deficiency , and heavy uterine bleeding