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Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease: The POPEYE
Nanja Bevers1, Els Van de Vijver2, Arta Aliu1
1Department of Paediatrics, Zuyderland Medical Center, Sittard, The Netherlands.
Insights
Intravenous iron rapidly improved physical fitness in anemic children with inflammatory bowel disease (IBD). However, long-term benefits and hemoglobin increases were similar to oral iron, with no significant differences observed after three months.
Area of Science:
- Pediatric Gastroenterology
- Hematology
- Clinical Nutrition
Background:
- Anemia is common in children with inflammatory bowel disease (IBD).
- Iron supplementation is crucial for managing anemia in this population.
- The optimal route of iron administration (intravenous vs. oral) for improving physical fitness in anemic IBD children remains unclear.
Purpose of the Study:
- To compare the efficacy of intravenous (IV) iron versus oral iron in enhancing physical fitness in anemic children with IBD.
- To assess the impact of different iron supplementation routes on hemoglobin levels and physical endurance.
Main Methods:
- A randomized clinical trial involving 64 anemic children (aged 8-18) with IBD.
- Participants received either a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate.
- Primary endpoint: change in 6-minute walking distance (6MWD) z-score; Secondary endpoint: change in hemoglobin (Hb) z-score.
Main Results:
- IV iron led to a significantly faster improvement in 6MWD z-score at one month compared to oral iron (0.71 vs. -0.11, P=0.01).
- No significant differences in 6MWD z-scores were observed between groups at 3 and 6 months.
- Hemoglobin z-scores increased comparably in both groups throughout the 6-month follow-up period.
Conclusions:
- A single IV dose of ferric carboxymaltose offers a rapid improvement in physical fitness for anemic children with IBD.
- Over longer periods (3-6 months), oral iron demonstrates comparable efficacy to IV iron regarding physical fitness and hemoglobin normalization.
- Both IV and oral iron therapies are effective, but IV iron provides a quicker initial boost in physical capacity.
Objective:
To determine whether intravenous (IV) or oral iron suppletion is superior in improving physical fitness in anemic children with inflammatory bowel disease (IBD).
Study Design:
We conducted a clinical trial at 11 centers. Children aged 8-18 with IBD and anemia (defined as hemoglobin [Hb] z-score < -2) were randomly assigned to a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate. Primary end point was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. Secondary outcome was a change in Hb z-score from baseline.
Results:
We randomized 64 patients (33 IV iron and 31 oral iron) and followed them for 6 months. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with -0.11 in the oral group (P = .01). At 3- and 6-month follow-ups, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3, and 6 months after initiation of iron therapy (overall P = .97).
Conclusion:
In this trial involving anemic children with IBD, a single dose of IV ferric carboxymaltose was superior to oral ferrous fumarate with respect to quick improvement of physical fitness. At 3 and 6 months after initiation of therapy, no differences were discovered between oral and IV therapies. The increase of Hb over time was comparable in both treatment groups.
Trial Registration:
NTR4487 [Netherlands Trial Registry].
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