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.
Arizona Health Sciences Center, University of Arizona College of Medicine, 1821 East Elm Street, Tucson, AZ 85719, USA. anwyck@email.arizona.edu
David B
DB
Van Wyck
Mark G
MG
Martens
Melvin H
MH
Seid
Jeffrey B
JB
Baker
Antoinette
A
Mangione
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