Publication:

Comparative efficacy and safety of ferric carboxymaltose, iron sucrose and iron sorbitol in treatment of iron deficiency anemia in Indian pregnant women

Background There’s paucity of data on comparative efficacy and safety of ferric carboxymaltose (FCM), iron sucrose (IS) and iron sorbitol (ISr) in management of iron deficiency anemia (IDA) in pregnancy. Present study assessed the efficacy and safety of these iron preparations in management of IDA in Indian pregnant women.

Methods This was a single-centre, parallel-group, open-label, randomised clinical trial. Total 150 pregnant women of 24 to 34 weeks of gestation with IDA and hemoglobin between 6.5 to <9.0g/dL, were randomised to three groups to receive either FCM, IS or ISr. Primary outcome was improvement in hemoglobin and serum ferritin levels with FCM, IS and ISr. Comparative improvement in other hematological parameters, tolerability and safety were also analysed.

Results At 2 weeks, significant increase in hemoglobin of 1.86 g/dL was noted with FCM compared to 1.24 and 0.83 g/dL with IS and ISr respectively. At 6 weeks, increase in hemoglobin with FCM (4.02 g/dL) was almost two times of that with ISr (2.08 g/dL) and almost 1.4 times of that with IS (2.87g/dL). Significant improvement in serum ferritin was noted with FCM (25.59 µg/L) compared to IS (18.86 µg/L) and ISr (13.84 µg/L) at 2 weeks and also at 6 weeks (87.71 vs. 65.22 vs. 43.5 µg/L). Improvement in other hematological parameters was also significantly more with FCM compared to IS and ISr. Minor adverse effects were seen with IS and FCM. No serious adverse effects were reported in any group.

Conclusions FCM 1000 mg rapidly corrects hemoglobin and replenishes iron stores in pregnant women with moderate to severe anemia reporting in third trimester.