A Randomized Controlled Trial Comparing Ferric Carboxy-Maltose With Iron Sucrose Complex for Postpartum Iron-Deficiency Anemia.

OBJECTIVE

To determine the efficacy of parenteral iron carboxy-maltose (FCM) versus iron sucrose complex (ISC) for the treatment of postpartum iron-deficiency anemia (IDA).

METHODS

A randomized controlled trial was conducted among postpartum women with IDA. Primary outcome was to compare the efficacy of FCM versus ISC in the improvement of hemoglobin (Hb), RBC indices (mean corpuscular Hb (MCH), mean corpuscular volume (MCV), mean corpuscular Hb concentration (MCHC)), and iron stores (serum iron, serum ferritin, percentage saturation of iron, and total iron binding capacity). Secondary outcomes were side-effect profile and maternal complications. At enrolment, 500 women were randomized to two groups. Demographic and clinical data were collected at enrolment and four weeks later.

RESULTS

Women receiving FCM had statistically significantly higher Hb levels (g/dl) (11.4 (10.3-12.5) vs. 11 (9.1-12.9), p<0.001), better RBC indices (MCV (fl); 96.5 (87.5-105) vs. 92 (77-107), p<0.001, MCH (pg/cell); 32 (27-37) vs. 30 (25-35), p<0.001, MCHC (g/dl); 36 (31-41) vs. 34 (30-38), p=0.001) and better iron stores (serum ferritin (µg/l); 290 (273-307) vs. 229 (213-245), p<0.001, and percentage saturation of iron (%); 24.5 (16.5-32.5) vs. 21 (16-26), p<0.001). However, there was no difference regarding serum iron (p=0.513) and total iron binding capacity (p=0.298). ISC had poor compliance as 23 (9.2%) women did not come for repeated doses. Secondary outcomes (side-effect profile (p=0.797) and maternal complications (p=0.176)) were comparable among women.

CONCLUSION

Ferric carboxymaltose has better efficacy and compliance for the treatment of postpartum iron-deficiency anemia as compared to iron-sucrose complex, with a similar side effect profile. We recommend that women with postpartum iron deficiency anemia (Hb 7-11 g%) receive at least a single parenteral FCM (1000 mg) before discharge from the hospital as a standard policy, especially in low- and middle-income countries.