Efficacy, Tolerability, and Acceptability of Iron Hydroxide Polymaltose Complex versus Ferrous Sulfate: A Randomized Trial in Pediatric Patients with Iron Deficiency Anemia. (31st October 2011)

• Record Type: Journal Article
• Authors: Yasa, Beril; Agaoglu, Leyla; Unuvar, Emin
• Other Names: Walther Frans J. Academic Editor.
• Is Part Of: International journal of pediatrics. Volume 2011(2011)
• Publication Date: 2011-10-31
• Subjects: Pediatrics -- Periodicals; 618.92
• DOI: 10.1155/2011/524520
• Languages: English
• ISSNs: 1687-9740

Abstract

Abstract : Iron polymaltose complex (IPC) offers similar efficacy with superior tolerability to ferrous sulfate in adults, but randomized trials in children are rare. In a prospective, open-label, 4-month study, 103 children aged >6 months with iron deficiency anemia (IDA) were randomized to IPC once daily or ferrous sulfate twice daily, (both 5 mg iron/kg/day). Mean increases in Hb to months 1 and 4 with IPC were1.2 ± 0.9 g/dL and2.3 ± 1.3 g/dL, respectively, (bothP = 0.001 versus baseline) and1.8 ± 1.7 g/dL and3.0 ± 2.3 g/dL with ferrous sulfate (bothP = 0.001 versus baseline) (n.s. between groups). Gastrointestinal adverse events occurred in 26.9% and 50.9% of IPC and ferrous sulfate patients, respectively (P = 0.012 ). Mean acceptability score at month 4 was superior with IPC versus ferrous sulfate (1.63 ± 0.56 versus2.14 ± 0.75, P = 0.001 ). Efficacy was comparable with IPC and ferrous sulfate over a four-month period in children with IDA, but IPC was associated with fewer gastrointestinal adverse events and better treatment acceptability.