Background: The post-authorisation registry, European Increlex® (mecasermin (rDNA origin) injection) Growth European Increlex Growth Forum Database (EU-IGFD), initiated in December 2008, collects safety and efficacy data in children receiving Increlex® for growth failure. Hypoglycaemia has been reported as a common adverse event (AE) during any IGF1 replacement therapy in randomised clinical trials, and is therefore of interest in real-life settings captured in registries.
Objective and hypotheses: To investigate hypoglycaemic AEs reported in the EU-IGFD registry and identify predictive factors.
Method: Multicentre, open-label observational study, multivariate analysis.
Results: As of 2 October 2014, 61 hypoglycaemic events (27 suspected, 26 verified, eight not specified) were reported in 34/200 patients of the safety population (17.0%), making them the most frequently reported targeted AE. Eight serious AEs of hypoglycaemia were reported in five patients. In three patients, episode(s) occurred following fasting or exercise without food intake. In patients with hypoglycaemia, diagnosis of Laron syndrome (LS) was more common (35.3% vs 10.2%, P<0.001) and they tended to be younger at first Increlex® intake (median age: 8.9 vs 10.8 years, P=0.165) and to have more often prior history of hypoglycaemia (11.8% vs 4.8%, P=0.133). In the multivariate analysis, only LS was identified as predictive factor for hypoglycaemia (OR (CI 95%): 0.21; (0.09; 0.50)). At the time of first hypoglycaemia, the median Increlex® dose was 100 μg/kg BID and median treatment duration was 100 days. Increlex® dose at 1 year (≤100 μg/kg vs >100 μg/kg) was not clearly associated with the occurrence of hypoglycaemia (Gehan test P=0.16).
Conclusion: Rates of hypoglycaemic AE reported in Increlex®-treated patients in the EU-IGFD registry were similar or lower than rates reported previously (1486%). LS was identified as an independent predictive factor for occurrence of hypoglycaemic AE while age and dose were not.
Conflict of interest: AH and CS: employees of Ipsen. MP and JW: advisory boards for Ipsen and Novo Nordisk.
Funding: This work and the study on which it is based were supported by Ipsen.
01 Oct 2015 - 03 Oct 2015