Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial.
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 to 1,000 mg over 15 minutes, repeated weekly to achieve a total calculated replacement dose) or ferrous sulfate (FeSO(4)) 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 FeSO(4). 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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00396292


METHODS
I.
Van Wyck
David B
DB
Arizona Health Sciences Center, University of Arizona College of Medicine, 1821 East Elm Street, Tucson, AZ 85719, USA. anwyck@email.arizona.edu
Martens
Mark G
MG
Seid
Melvin H
MH
Baker
Jeffrey B
JB
Mangione
Antoinette
A
D000284:Administration, Oral; D000328:Adult; D000740:Anemia / Q000188:drug therapy*; D019587:Dietary Supplements; D004334:Drug Administration Schedule; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005296:Ferrous Compounds / Q000008:administration & dosage*; D006397:Hematinics / Q000008:administration & dosage*; D006454:Hemoglobins / Q000187:drug effects; D006801:Humans; D007275:Injections, Intravenous; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008800:Mexico; D049590:Postpartum Period / Q000097:blood / Q000187:drug effects*; D011247:Pregnancy; D014481:United States
D005290:Ferric Compounds; D005296:Ferrous Compounds; D006397:Hematinics; D006454:Hemoglobins; C020748:ferrous sulfate; C522335:ferric carboxymaltose; D008320:Maltose