Endocrine Abstracts

Introduction: PATRO adults is an international, longitudinal, non-interventional study of the long-term safety and efficacy of recombinant human growth hormone (rhGH; Omnitrope^®, Sandoz). The study will provide additional data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.

Methods: Eligible patients are adults who are receiving treatment with Omnitrope^® and have provided informed consent. Patients treated with another rhGH before starting Omnitrope^® therapy are eligible for inclusion. The primary objective is to assess the safety and efficacy of Omnitrope^® in adults treated in routine clinical practice, with particular emphasis on the risk of glucose intolerance or diabetes and normalisation of IGF-I levels.

Results: As of November 2015, 996 patients have been enrolled in the study; 548 (55%) have received previous GH treatment. Mean (S.D.) age of subjects is 50.0 (15.2) years, and mean (S.D.) BMI is 29.4 (6.1) kg/m². To date, 1772 AEs have been reported in 539 (54%) patients, with 273 (15%, in 164 [16.5%] patients) regarded as serious. One-hundred-and-ten AEs (6%) in 67 (6.7%) patients were suspected as drug-related. These included 18 nervous system disorders, 17 general disorders/administration site conditions, 16 musculoskeletal/connective tissue disorders and two investigations (increased IGF levels). A total of 22 SAEs in 20 (2%) patients were suspected as related to Omnitrope^® treatment, including one incidence of diabetes mellitus. Of the 127 patients who have discontinued treatment, 31 did so due to an AE.

Conclusions: Based on this interim analysis, Omnitrope^® treatment in adults with GHD is well tolerated in real-life clinical practice, both in rhGH-naïve and previously treated patients. The PATRO adults study will continue to provide important data on the diabetogenic potential and overall safety of long-term GH treatment in this population.