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Obstetrics & Gynecology 2007;110:267-278
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Postpartum Anemia

A Randomized Controlled Trial

David B. Van Wyck, MD1, Mark G. Martens, MD2, Melvin H. Seid, MD3, Jeffrey B. Baker, MD4 and Antoinette Mangione, MD, PharmD5

From the 1University of Arizona College of Medicine, Tucson, Arizona; 2University of Oklahoma Health Sciences Center, Tulsa, Oklahoma; 3Lyndhurst Gynecologic Associates, Winston-Salem, North Carolina; 4Windmark Women Care Specialists, Idaho Falls, Idaho; and 5American Regent, Inc, Norristown, Pennsylvania.

OBJECTIVE: To estimate efficacy of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose compared with oral iron therapy in anemic postpartum women.

METHODS: In a randomized, controlled trial, we assigned anemic women (hemoglobin [Hb] less than or equal to 10 g/dL) within 10 days postpartum to receive either IV ferric carboxymaltose (less than or equal to1,000 mg over 15 minutes, repeated weekly to achieve a total calculated replacement dose) or ferrous sulfate (FeSO4) 325 mg orally thrice daily for 6 weeks.

RESULTS: One hundred seventy-four patients received 350 IV doses of ferric carboxymaltose (mean total dose 1,403.1 mg) in 3, 2, or 1 injection (10.9%, 79.3%, or 9.8% of patients, respectively); 178 received FeSO4. Patients assigned to IV ferric carboxymaltose compared with those assigned to oral iron achieved a Hb rise greater than or equal to 2.0 g/dL earlier (7.0 compared with 14.0 days, P<.001), were more likely to achieve a Hb rise greater than or equal to 3.0 g/dL at any time (86.3% compared with 60.4%, P<.001), and were more likely to achieve a Hb greater than 12.0 g/dL (90.5% compared with 68.6%, P<.001). A similar proportion of patients achieved a Hb rise greater than or equal to 2.0 g/dL (96.4% compared with 94.1%, IV compared with oral, P=.443). There were no serious adverse drug reactions.

CONCLUSION: Large-dose IV ferric carboxymaltose administration is a new iron agent that is effective for the treatment of postpartum anemia. When compared with oral ferrous sulfate, IV ferric carboxymaltose is better tolerated, prompts a more rapid Hb response, and corrects anemia more reliably.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00396292

LEVEL OF EVIDENCE: I






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