Efficacy and safety of oral iron(iii) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia:a multicenter, randomized, controlled study

Objective: To evaluate the efficacy and safety of iron (III) polymaltose complex (Maltofer) versus ferrous sulfate in iron-deficient pregnant women using recommended doses. Methods: An exploratory, open-label, randomized, controlled, multicenter study was undertaken in 80 pregnant women with iron-deficiency anemia (hemoglobin ≤ 10,5 g/dL, serum ferritin ≤ 15 ng/mL and mean corpuscular volume < 80 fL). Patients were randomized 1:1 to oral iron(III) polymaltose complex or ferrous sulfate (each 100 mg iron twice daily) for 90 days. Results: The primary endpoint, change in hemoglobin from baseline to days 60 and 90, did not differ significantly between treatment groups. The mean change to day 90 was 2,16 (0,67) g/dL in the iron (III) polymaltose complex group and 1,93 (0,97) g/dL in the ferrous sulfate group. Mean serum ferritin at day 90 was 179 (38) ng/mL and 157 (34) ng/mL with iron (III) polymaltose complex and ferrous sulfate, respectively (p = 0,014). Adverse events were significantly less frequent in the iron (III) polymaltose group, occurring in 12/41 (29,3%) patients, than in the ferrous sulfate group (22/39 [56,4%]) (p = 0,015). Conclusions: Oral iron (III) polymaltose complex offers at least equivalent efficacy and a superior safety profile compared to ferrous sulfate for the treatment of iron-deficiency anemia during pregnancy.