ECE2014 Poster Presentations Growth hormone IGF axis basic (16 abstracts)
Latest results from the PATRO Adults study of Omnitrope® for the treatment of adult patients with GH deficiency
Paolo Beck-Peccoz 1 , Charlotte Höybye 2 , Robert D Murray 3 , Suat Simsek 4 , Alfonso Leal-Cerro 5 , Francesco Minuto 6 , Markus Zabransky 7 & Gunter Stalla 8
1Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy; 2Karolinska University Hospital, Stockholm, Sweden; 3Leeds Teaching Hospitals NHS Trust, Leeds, UK; 4VU University Medical Center, Amsterdam, The Netherlands; 5Hospital Universitario Virgen del Rocío Seville, Seville, Spain; 6University of Genova, Genova, Italy; 7Sandoz International GmbH, Holzkirchen, Germany; 8Max Planck Institute of Psychiatry, Munich, Germany.
Introduction: PATRO adults is an ongoing, international, open, longitudinal, non-interventional study of the long-term safety and efficacy of Omnitrope (Sandoz), a recombinant human GH (rhGH). This 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 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. Particular emphasis is placed on the risk of glucose intolerance or diabetes and normalisation of IGF1 levels.
Results: To date (November 2013), 600 patients have been enrolled in the study; 309 (52%) have received previous GH treatment. Mean (S.D.) age of enrolled patients is 50.4 (15.3) years, and mean (SD) BMI is 29.5 (6.4) kg/m2. So far, 438 adverse events (AEs) have been reported in 157 (26%) patients, with 47 (10.7%, in 29 (5%) patients) regarded as serious. Thirty-nine AEs (8.9%) in 25 (4.2%) patients were suspected as drug-related. These included ten nervous system disorders, eight general disorders/administration site conditions, seven musculoskeletal/connective tissue disorders and three investigations (increased IGF levels). One serious AE (dyspnoea) in 1 (0.2%) patient was suspected as drug-related. Of the 50 patients who have discontinued treatment, 10 (1.6%) did so due to an AE.
Conclusions: On the basis of this interim analysis, Omnitrope treatment in adults with GHD is well tolerated in a real-life clinical practice setting, both in rhGH-naïve and previously treated patients. The ongoing PATRO Adults study will provide important data on the diabetogenic potential and overall safety of long-term GH treatment in this population.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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