Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the European Increlex® Growth Forum Database (Eu-IGFD) Registry
Authors' 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.
Study context
- Population
- Children/adolescents treated with rhIGF-1 (mecasermin) in the Eu-IGFD registry; 84.6% diagnosed with severe primary IGF-1 deficiency; data December 2008 to May 2021enrolled in registry
- Participants
- 306 participants
- Exposure
- Patients with ≥1 hypoglycemia AE vs no hypoglycemia adverse events (AEs)
- ≥1 hypoglycemia AEn = 80
- No hypoglycemia AEsn = 224reference
- Outcome
- Frequency and predictive factors for hypoglycemia AEs
Methodological detailsongoing surveillance registry, logistic regression
- Ongoing surveillance registry
- Logistic regression
Main finding
As reported in the abstract
Total hypoglycemia AEs per patient per treatment year
0.11
Total serious hypoglycemia AEs per patient per treatment year
0.01
Observational data: associations, not effects.
Further findings
Characteristics by hypoglycemia AE status
- Mean age at treatment start, ≥1 hypoglycemia AE vs none
- 8.7 years vs 9.8 years
- Laron syndrome diagnosis, ≥1 hypoglycemia AE vs none
- 27.5% vs 10.3%
- History of hypoglycemia, ≥1 hypoglycemia AE vs none
- 18.8% vs 4.5%
Safety
- Total hypoglycemia AEs per patient per treatment year
- 0.11
- Total serious hypoglycemia AEs per patient per treatment year
- 0.01
Original publication
Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry. J Clin Endocrinol Metab. Published 14 August 2023. doi:10.
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