Endocrine Abstracts

Introduction: More data are needed to confirm the long-term safety of recombinant human GH (rhGH) in adult patients with severe GH deficiency (GHD), particularly with regard to diabetogenic potential. PATRO Adults is an ongoing observational, multicentre, open, longitudinal study of Omnitrope, being conducted in hospitals and specialised endocrinology clinics across Europe. Here, we present safety data from an interim analysis.

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 product before starting Omnitrope therapy are eligible for inclusion. The overall primary objective of the study is to assess the safety and efficacy of Omnitrope in adults treated in routine clinical practice; particular emphasis will be placed on the risk of glucose intolerance or diabetes and normalisation of IGF1 levels.

Results: As of October 2012, 297 patients were enrolled in the study; 116 had received previous GH treatment. Mean (S.D.) age and body mass index of enrolled patients was 50.7 (15.4) years and 29.9 (6.8) kg/m² respectively. One hundred and fifteen adverse event (AEs) have been reported to date in 49 patients, with seven (in four patients) regarded as serious. Nine AEs in five patients were suspected as drug-related, with headache the most common (n=3). Eight patients have so far discontinued treatment (four were GHD-naive at study entry, four had received prior rhGH treatment). Of the eight patients who have discontinued, only one did so due to an AE.

Conclusions: Based on these interim results, Omnitrope treatment in adults with GHD is well tolerated in a real-life clinical practice setting, both in previously rhGH-naive and previously treated patients. The ongoing PATRO Adults study will provide important data on the diabetogenic potential and overall safety of long-term GH replacement therapy in this population.