Introduction: The ongoing, international, open, longitudinal, non-interventional study, PATRO Adults, aims to determine the long-term safety and efficacy of Omnitrope® (Sandoz), a recombinant human growth hormone (rhGH). Safety data from an interim analysis are presented here.
Methods: Eligible patients are male or female adults who are receiving treatment with Omnitrope® and who have provided informed consent. Patients treated with another rhGH before starting Omnitrope® therapy are eligible for inclusion. The primary objective of the study is to assess the safety and efficacy of Omnitrope® in adults treated in routine clinical practice, with particular emphasis placed on the risk of glucose intolerance or diabetes and normalisation of IGF-I levels.
Results: As of December 2016, 1121 patients had been enrolled on the study, of whom 586 (52.3%) were pre-treated with another rhGH. Mean (standard deviation [SD]) patient age is 49.7 (15.3) years, and mean (SD) BMI is 29.4 (6.3) kg/m2. In total 2455 adverse events (AEs) in 665 (59.3%) patients have been reported, with 444 (in 247 [22%] patients) of these regarded as serious. One hundred and thirty-nine AEs in 80 (7.1%) patients were suspected to be drug-related; these included general disorders/administration site conditions in 19 patients, nervous system disorders in 23 patients and musculoskeletal/connective tissue disorders in 24 patients. A total of 26 serious AEs in 17 (1.5%) patients were suspected to be related to Omnitrope® treatment, including one incidence of diabetes. Of the 188 patients who discontinued treatment, 47 (25%) did so due to an AE.
Conclusions: Based on this interim analysis, Omnitrope® treatment in adults with GHD is well tolerated in a real-life clinical practice setting, both in previously treated and rhGH-naïve patients. The ongoing PATRO Adults study will provide further data on the diabetogenic potential and overall safety of long-term GH treatment in this population.
20 - 23 May 2017
European Society of Endocrinology