Endocrine Abstracts

Introduction: PATRO adults is an ongoing, international, open, longitudinal, non-interventional study of the long-term safety and efficacy of recombinant human GH (rhGH; Omnitrope, Sandoz). The study will provide further 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: Adults who are receiving treatment with Omnitrope and who have provided informed consent are eligible for inclusion. Patients treated with another rhGH before starting Omnitrope therapy can also be included. The primary objective of the study is to assess the safety and efficacy of Omnitrope in adults treated in routine clinical practice. Particular emphasis is placed on the risk of glucose intolerance or diabetes and normalisation of IGF1 levels.

Results: As of November 2014, 800 patients have been enrolled in the study; 414 (52%) have received previous GH treatment. Mean (S.D.) age of enrolled patients is 50.4 (15.5) years, and mean (S.D.) BMI is 29.7 (6.5) kg/m². So far, 1033 adverse events (AEs) have been reported in 321 (40%) patients, with 92 (8.9%, in 59 (7.4%) patients) regarded as serious. Eighty-nine AEs (8.6%) in 58 (7.3%) patients were suspected as drug-related. These included 17 nervous system disorders, 17 general disorders/administration site conditions, 11 musculoskeletal/connective tissue disorders, and 11 investigations (increased IGF levels). One serious AE (dyspnoea) in 1 (0.2%) patient was suspected as drug-related. Seventy-six patients have discontinued treatment; 17 of these 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.

Disclosure: The PATRO adults study is funded by Sandoz.