TY - JOUR
T1 - Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease
T2 - The POPEYE Randomized Controlled Clinical Trial
AU - Bevers, Nanja
AU - Van de Vijver, Els
AU - Aliu, Arta
AU - Rezazadeh Ardabili, Ashkan
AU - Rosias, Philippe
AU - Stapelbroek, Janneke
AU - Bertrams Maartens, Imke A.
AU - van de Feen, Cathelijne
AU - Escher, Hankje
AU - Oudshoorn, Annemarie
AU - Teklenburg, Sarah
AU - Vande Velde, Saskia
AU - Winkens, Bjorn
AU - Raijmakers, Maarten
AU - Vreugdenhil, Anita
AU - Pierik, Marieke J.
AU - van Rheenen, Patrick F.
N1 - Supported through an unrestricted grant from Vifor Pharma, Glattbrugg, Switzerland; they had no role in the design nor in the collection, analysis, and interpretation of data, the writing of the report or the decision to submit the paper for publication.
Publisher Copyright:
© 2022 The Author(s)
PY - 2023/5
Y1 - 2023/5
N2 - 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].
AB - 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].
UR - http://www.scopus.com/inward/record.url?scp=85149700363&partnerID=8YFLogxK
U2 - 10.1016/j.jpeds.2022.12.016
DO - 10.1016/j.jpeds.2022.12.016
M3 - Article
C2 - 36563900
AN - SCOPUS:85149700363
SN - 0022-3476
VL - 256
SP - 113-119.e4
JO - Journal of Pediatrics
JF - Journal of Pediatrics
ER -