Latest Results from the Patro Adults Study of Omnitrope® for the Treatment of Adult Patients with Growth Hormone Deficiency

Presentation Number: LBF-078
Date of Presentation: March 6th, 2015

Paolo Beck-Peccoz*1, Charlotte Höybye2, Robert D Murray3, Suat Simsek4, Alfonso Leal-Cerro5, Markus Zabransky6 and Günter K. Stalla7
1Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy, 2Karolinska University Hospital, Stockholm, Sweden, 3Leeds Centre for Diabetes and Endocrinology, St James’s University Hospital, Leeds, United Kingdom, 4Medisch Centrum Alkmaar, Alkmaar, Netherlands, 5Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío Seville, Sevilla, Spain, 6Sandoz International GmbH, Holzkirchen, Germany, 7Max Planck Institute of Psychiatry, Munich, Germany

Abstract

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 growth hormone (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 IGF-1 levels.  

Results: To date (November 2014), 800 patients have been enrolled in the study; 414 (52%) have received previous GH treatment. Mean (SD) age of enrolled patients is 50.4 (15.5) years, and mean (SD) body mass index 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. Of the 76 patients who have discontinued treatment, 17 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.

 

Disclosure: PB: Speaker, Sandoz, Speaker, Eli Lilly & Company, Clinician, Pfizer, Inc.. CH: Advisory Group Member, Sandoz. RDM: Advisory Group Member, Sandoz. SS: Advisory Group Member, Sandoz. MZ: Employee, Sandoz. GKS: Advisory Group Member, Sandoz. Nothing to Disclose: AL