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


Ortiz, R; Toblli, J E; Romero, J D; Monterrosa, B; Frer, C; Macagno, E; Breymann, C (2011). Efficacy and safety of oral iron(III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study. Journal of Maternal-Fetal & Neonatal Medicine, 24(11):1-6.

Abstract

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.

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.

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4 citations in Web of Science®
14 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Obstetrics
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:November 2011
Deposited On:24 Jan 2012 14:10
Last Modified:05 Apr 2016 15:19
Publisher:Informa Healthcare
ISSN:1476-4954
Publisher DOI:https://doi.org/10.3109/14767058.2011.599080
Official URL:http://informahealthcare.com/doi/full/10.3109/14767058.2011.599080
PubMed ID:21859366
Permanent URL: https://doi.org/10.5167/uzh-54132

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