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 (SD) 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 (n.s). 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.