期刊
JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE
卷 24, 期 11, 页码 1347-1352出版社
TAYLOR & FRANCIS LTD
DOI: 10.3109/14767058.2011.599080
关键词
anemia; deficiency; ferrous; IPC; polymaltose; pregnancy; pregnant; iron; sulfate
资金
- Vifor (International) Inc.
- Vifor Pharma
- Vifor (International) Inc, St Gallen, Switzerland
Objective: To evaluate the efficacy and safety of iron(III) polymaltose complex (Maltofer (R)) 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.
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