Efficacy, Tolerability, and Acceptability of Iron Hydroxide Polymaltose Complex versus Ferrous Sulfate: A Randomized Trial in Pediatric Patients with Iron Deficiency Anemia

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 were 1.2 ± 0.9 g/dL and 2.3 ± 1.3 g/dL, respectively, (both P = 0.001 versus baseline) and 1.8 ± 1.7 g/dL and 3.0 ± 2.3 g/dL with ferrous sulfate (both P = 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 versus 2.14 ± 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.

Figure 1

Acceptability score in pediatric patients with iron deficiency anemia receiving oral iron therapy in the form of iron hydroxide polymaltose complex (IPC) or ferrous sulfate. Acceptability was assessed using the Wong-Baker scale [15], on which a “happy face” (score 0) stands for no difficulties, while a “sad face” (score 5) indicates that the child refused or was forced to take the medicine.