Support for this study was provided by American Regent, Inc., the human drug division of Luitpold Pharmaceuticals, Shirley, NY.
BLOOD MANAGEMENT: Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial
Article first published online: 22 JUL 2009
© 2009 American Association of Blood Banks
Volume 49, Issue 12, pages 2719–2728, December 2009
How to Cite
Van Wyck, D. B., Mangione, A., Morrison, J., Hadley, P. E., Jehle, J. A. and Goodnough, L. T. (2009), BLOOD MANAGEMENT: Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion, 49: 2719–2728. doi: 10.1111/j.1537-2995.2009.02327.x
ClinicalTrials.gov Trial Identifier: NCT00395993.
- Issue published online: 1 DEC 2009
- Article first published online: 22 JUL 2009
- Received for publication March 5, 2009; revision received May 26, 2009, and accepted May 26, 2009.
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.