Frequency and predictive factors of hypoglycemia in patients treated with rhIGF-1: Data from the Eu-IGFD Registry
Peter Bang, Michel Polak, Artur Bossowski, Mohamad Maghnie, Jesús Argente, Marta Ramon-Krauel, Caroline Sert, Valerie Perrot, Sarah Mazain, Joachim Woelfle- Biochemistry (medical)
- Clinical Biochemistry
- Endocrinology
- Biochemistry
- Endocrinology, Diabetes and Metabolism
Abstract
Purpose
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). 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% confidence intervals (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=0.002) and Laron syndrome diagnosis (OR 0.36; 95% CI: [0.18; 0.72]; p=0.004) 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.
Conclusions
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 adverse event throughout treatment.