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BLOOD MANAGEMENT: Large‐dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial
Author(s) -
Van Wyck David B.,
Mangione Antoinette,
Morrison John,
Hadley Phillip Earl,
Jehle Judi A.,
Goodnough Lawrence Tim
Publication year - 2009
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2009.02327.x
Subject(s) - anemia , medicine , ferrous , iron deficiency anemia , gastroenterology , iron deficiency , randomized controlled trial , surgery , chemistry , organic chemistry
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 (≤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 ≥ 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.