Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry.

Bang P, Polak M, Bossowski A, Maghnie M, Argente J, Ramon-Krauel M, Sert C, Perrot V, Mazain S, Wölfle J (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Journal of Clinical Endocrinology and Metabolism Oxford University Press

Book Volume: 109

Pages Range: 46-56

Journal Issue: 1

DOI: 10.1210/clinem/dgad479

Abstract

CONTEXT: The European Increlex® Growth Forum Database (Eu-IGFD) is an ongoing surveillance registry (NCT00903110) established to collect long-term safety and effectiveness data on the use of recombinant human insulin-like growth factor-1 (rhIGF-1, mecasermin, Increlex) for the treatment of children/adolescents with severe primary insulin-like growth factor-1 deficiency (SPIGFD). OBJECTIVE: This analysis of Eu-IGFD data aimed to identify the frequency and predictive factors for hypoglycemia adverse events (AEs) in children treated with rhIGF-1. METHODS: Data were collected from December 2008 to May 2021. Logistic regression was performed to identify predictive risk factors for treatment-induced hypoglycemia AEs. Odds ratios (ORs) are presented with 95% CIs for each factor. RESULTS: In total, 306 patients were enrolled in the registry; 84.6% were diagnosed with SPIGFD. Patients who experienced ≥ 1 hypoglycemia AE (n = 80) compared with those with no hypoglycemia AEs (n = 224) had a lower mean age at treatment start (8.7 years vs 9.8 years), a more frequent diagnosis of Laron syndrome (27.5% vs 10.3%), and a history of hypoglycemia (18.8% vs 4.5%). Prior history of hypoglycemia (OR 0.25; 95% CI: [0.11; 0.61]; P = .002) and Laron syndrome diagnosis (OR 0.36; 95% CI: [0.18; 0.72]; P = .004) predicted future hypoglycemia AEs. Total hypoglycemia AEs per patient per treatment year was 0.11 and total serious hypoglycemia AEs per patient per treatment year was 0.01. CONCLUSION: Hypoglycemia occurs more frequently in patients with prior history of hypoglycemia and/or Laron syndrome compared with patients without these risk factors, and these patients should be carefully monitored for this AE throughout treatment.

Authors with CRIS profile

Joachim Wölfle Lehrstuhl für Kinder- und Jugendmedizin

Involved external institutions

Hôpital Necker-Enfants malades FR France (FR) Medical University of Bialystok PL Poland (PL) Istituto Giannina Gaslini IT Italy (IT) Hospital Infantil Universitario Niño Jesús / Hospital del Niño Jesús ES Spain (ES) Hospital Sant Joan de Déu Barcelona ES Spain (ES) Ipsen Pharma FR France (FR) Linköping University SE Sweden (SE)

How to cite

APA:

Bang, P., Polak, M., Bossowski, A., Maghnie, M., Argente, J., Ramon-Krauel, M.,... Wölfle, J. (2023). Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry. Journal of Clinical Endocrinology and Metabolism, 109(1), 46-56. https://doi.org/10.1210/clinem/dgad479

MLA:

Bang, Peter, et al. "Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry." Journal of Clinical Endocrinology and Metabolism 109.1 (2023): 46-56.

BibTeX: Download