Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial - 21/08/11
, Richard J. Derman, MD, FACOG b, Jeffrey B. Baker, MD, FACOG c, Warren Banach, MD, FACOG d, Cynthia Goldberg, MD, FACOG e, Ralph Rogers, MD, FACOG f
Reprints: Melvin H. Seid, MD, FACOG, CPI, Lyndhurst Gynecologic Associates, 2927 Lyndhurst Ave, Winston-Salem, NC 27103Résumé |
Objective |
The objective of the study was to evaluate the efficacy, safety, and tolerability of intravenous ferric carboxymaltose, compared with oral ferrous sulfate in women with postpartum anemia.
Study Design |
In a multicenter, randomized, controlled study, 291 women less than 10 days after delivery with hemoglobin 10 g/dL or less were randomized to receive ferric carboxymaltose (n = 143) 1000 mg or less intravenously over 15 minutes or less, repeated weekly to a calculated replacement dose (maximum 2500 mg) or ferrous sulfate (n = 148) 325 mg orally thrice daily for 6 weeks.
Results |
Ferric carboxymaltose-treated subjects were significantly more likely to: (1) achieve a hemoglobin greater than 12 g/dL in a shorter time period with a sustained hemoglobin greater than 12 g/dL at day 42, (2) achieve hemoglobin rise 3 g/dL or greater more quickly, and (3) attain higher serum transferrin saturation and ferritin levels. Drug-related adverse events occurred less frequently with ferric carboxymaltose.
Conclusion |
Intravenous ferric carboxymaltose was safe and well tolerated with an efficacy superior to oral ferrous sulfate in the treatment of postpartum iron deficiency anemia.
Le texte complet de cet article est disponible en PDF.Key words : ferric carboxymaltose, ferrous sulfate, intravenous iron, iron deficiency anemia, postpartum
Plan
| Cite this article as: Seid MH, Derman RJ, Baker JB, et al. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008;199:435.e1-435.e7. |
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| • The authors received research grants from American Regent, Inc to conduct this study and are currently receiving grants to conduct another study with the same product. None of the authors are current or former employees or consultants of American Regent, Inc. None report owning stock or stock options in the company. None of the authors report having a financial interest in the product. Drs Derman and Seid have served on the speaker's bureau for American Regent, Inc in the last year. |
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| • The authors thank all study investigators for their help in conducting the trial. We also thank Quinn Dinh, MD (consultant to Luitpold Pharmaceuticals Inc, Norristown, PA), Jessica D. Herr, PharmD (Lansdale, PA), and William C. Fridrich, RPh (American Regent, Inc, Shirley, NY) for editorial support in preparation of this manuscript. |
Vol 199 - N° 4
P. 435.e1-435.e7 - octobre 2008 Retour au numéro
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