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Efficacy, Tolerability, and Acceptability of Iron Hydroxide Polymaltose Complex versus Ferrous Sulfate: A Randomized

Beril Yasa1, Leyla Agaoglu, Emin Unuvar

  • 1Department of Pediatric Hematology/Oncology, Istanbul Medical School, University of Istanbul, Capa 34093, Istanbul, Turkey.

International Journal of Pediatrics
|November 29, 2011
PubMed

Insights

Iron polymaltose complex (IPC) and ferrous sulfate show comparable efficacy for treating iron deficiency anemia in children. IPC demonstrated superior tolerability and acceptability, with fewer gastrointestinal side effects.

Area of Science:

  • Pediatric Hematology
  • Clinical Nutrition
  • Pharmacology

Background:

  • Iron deficiency anemia (IDA) is a prevalent pediatric condition.
  • Ferrous sulfate is a common treatment, but gastrointestinal side effects can limit adherence.
  • Limited data exists on iron polymaltose complex (IPC) efficacy and tolerability in pediatric IDA.

Purpose of the Study:

  • To compare the efficacy and tolerability of iron polymaltose complex (IPC) versus ferrous sulfate in children with IDA.
  • To evaluate treatment acceptability and adverse events in pediatric patients.

Main Methods:

  • A prospective, open-label, 4-month study randomized 103 children (>6 months) with IDA.
  • Participants received either IPC or ferrous sulfate (5 mg iron/kg/day).
  • Efficacy (Hb levels), adverse events, and acceptability were assessed.

Main Results:

  • Both IPC and ferrous sulfate significantly increased Hb levels from baseline (P=0.001).
  • No significant difference in Hb increase was observed between the two groups.
  • IPC showed significantly fewer gastrointestinal adverse events (26.9% vs 50.9%, P=0.012) and higher acceptability (P=0.001).

Conclusions:

  • Iron polymaltose complex is an effective alternative to ferrous sulfate for pediatric IDA.
  • IPC offers improved gastrointestinal tolerability and patient acceptability compared to ferrous sulfate.
  • Further research can explore long-term outcomes and optimal dosing strategies for IPC in children.

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