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.