55: Treating postpartum anemia with intravenous ferric carboxymaltose in a randomized controlled study

A RANDOMIZED CONTROLLED STUDY MELVIN H. SEID, RALPH ROGERS, QUINN DINH, Lyndhurst Gynecologic Associates, Winston Salem, North Carolina, Women’s Clinical Research, Newburgh, Indiana, American Regent/Luitpold Pharmaceuticals, Norristown, Pennsylvania OBJECTIVE: To evaluate the superiority, safety and tolerability of ferric carboxymaltose (FCM) to oral iron in postpartum women with iron deficiency anemia (IDA). FCM is a novel non-dextran iron agent given in large doses by rapid IV injection. STUDY DESIGN: In a randomized, controlled, superiority designed pivotal trial, 289 women 10 days post-delivery with hemoglobin 10g/dL were randomized and received: (a) FCM up to 1,000mg IV over 15 minutes, repeated weekly to correct anemia up to maximum total calculated dose of 2,500mg, or (b) Oral ferrous sulfate 325mg (65mg elemental iron) thrice daily for 6 weeks. RESULTS: Patients (n 142) received 293 IV doses of FCM (mean total dose 1504mg) in 1, 2, or 3 injection(s) [5%, 84%, or 11% respectively]; 147 received oral iron. FCM group compared with oral iron group was: (1) more likely to achieve hemoglobin (Hb) 12g/dL (91% vs. 67%, p .0001) in a shorter time period (14 days vs. 27 days, p .0002) with sustained success (85% vs. 58%) at Day 42, (p .0001), (2) more likely to achieve Hb rise 3.0g/dL at any time (91% vs. 65%, p .0001) in a shorter time period (15 days vs. 28 days, p .0001), and (3) more likely to attain higher transferrin saturation (TSAT) (36% vs. 28%) and ferritin (647 ng/mL vs. 12 ng/mL), p .0001. Drug-related adverse events (AEs) were lower with FCM (11%) than oral iron (22%). Urticaria (2%) was the only drug-related AE occurring in 2% of the FCM group. Constipation (11%;0%), elevated ALT (4%; 0.7%), elevated AST (2%;0.7%), and nausea (2%;1.4%) were more common with oral iron than FCM, respectively. No hypotensive or drug-related serious AEs such as hypersensitivity or anaphylactic reactions were reported in either treatment group. CONCLUSION: Ferric carboxymaltose (FCM) was safe and well-tolerated. FCM was superior to oral iron in increasing Hb 12g/dL earlier with greater sustained success. FCM was more effective in raising TSAT and ferritin. This non-dextran IV iron agent may fulfill an unmet medical need for safe, rapid administration of iron in single doses up to 1,000mg in postpartum women with IDA.