M Arosio1,2, G Arnaldi3, V Gasco4, C Giavoli5,6, E Puxeddu7, R Vettor8, M R Ambrosio9, P Gallinari10, H Zouater11, P Fedeli10, D Ferone12. 1. Department of Medical Sciences and Community Health, University of Milan, Milan, Italy. 2. Unit of Endocrinology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, pad. Zonda via F. Sforza 35, 20123, Milan, Italy. 3. Division of Endocrinology, Ospedali Riuniti Di Ancona, Ancona, Italy. 4. Division of Endocrinology, Diabetes and Metabolism, Department of Medical Sciences, University of Turin, Turin, Italy. 5. Department of Medical Sciences and Community Health, University of Milan, Milan, Italy. claudia.giavoli@policlinico.mi.it. 6. Unit of Endocrinology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, pad. Zonda via F. Sforza 35, 20123, Milan, Italy. claudia.giavoli@policlinico.mi.it. 7. Department of Medicine, Section of Endocrinology, Medical School, University of Perugia, Perugia, Italy. 8. Internal Medicine 3, Department of Medicine-DIMED, University of Padova, Padova, Italy. 9. Section of Endocrinology and Internal Medicine, Department of Medical Sciences, S. Anna University Hospital of Ferrara, University of Ferrara, Ferrara, Italy. 10. Sandoz S.P.A., Origgio, MI, Italy. 11. Sandoz Biopharmaceutical C/O HEXAL AG, Holzkirchen, Germany. 12. Department of Internal Medicine and Medical Specialties (DiMI), Center of Excellence for Biomedical Research (CEBR), IRCCS AOU San Martino-IST, University of Genoa, Genoa, Italy.
Abstract
PURPOSE: PATRO adults is an ongoing, multicenter, observational, post-marketing surveillance study aimed at investigating the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the recombinant human growth hormone (rhGH) Omnitrope® during routine clinical practice. This report describes data from Italian participants in PATRO Adults with growth hormone deficiency (GHD), up to August 2017. METHODS: Participants were adults (aged > 18 years) with GHD requiring rhGH therapy and were prescribed Omnitrope®, including those who had previously received another rhGH product. Adverse events (AEs) were evaluated in all study participants. Data were collected on insulin-like growth factor (IGF)-I levels and cardiovascular risk factors, including blood pressure, lipids, and anthropometric parameters. RESULTS: From September 2007 to August 2017, 88 patients (mean age 48.9 years, 58.0% male) were enrolled at 8 sites in Italy. The mean treatment duration with Omnitrope® was 51.5 ± 37 months. AEs occurred in 54 patients; the most common were asthenia (20.5%), headache (14.8%), and arthralgia (13.6%). Serious AEs occurred in 22 patients (25%), including pneumonia (n = 2) and renal failure (n = 2). Neoplasms (2 benign and 1 malignant) developed in three patients, but none were considered to be drug-related. There were no significant changes in fasting glucose or glycosylated hemoglobin (HbA1c) during the study period. Long-term Omnitrope® therapy showed slight positive effects on lipid profile, while no significant changes were observed in body weight and BMI during the study. CONCLUSION: This snapshot analysis of Italian participants in PATRO Adults confirmed the long-term safety and effectiveness of Omnitrope® in adults with GHD.
PURPOSE: PATRO adults is an ongoing, multicenter, observational, post-marketing surveillance study aimed at investigating the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the recombinant humangrowth hormone (rhGH) Omnitrope® during routine clinical practice. This report describes data from Italian participants in PATRO Adults with growth hormone deficiency (GHD), up to August 2017. METHODS:Participants were adults (aged > 18 years) with GHD requiring rhGH therapy and were prescribed Omnitrope®, including those who had previously received another rhGH product. Adverse events (AEs) were evaluated in all study participants. Data were collected on insulin-like growth factor (IGF)-I levels and cardiovascular risk factors, including blood pressure, lipids, and anthropometric parameters. RESULTS: From September 2007 to August 2017, 88 patients (mean age 48.9 years, 58.0% male) were enrolled at 8 sites in Italy. The mean treatment duration with Omnitrope® was 51.5 ± 37 months. AEs occurred in 54 patients; the most common were asthenia (20.5%), headache (14.8%), and arthralgia (13.6%). Serious AEs occurred in 22 patients (25%), including pneumonia (n = 2) and renal failure (n = 2). Neoplasms (2 benign and 1 malignant) developed in three patients, but none were considered to be drug-related. There were no significant changes in fasting glucose or glycosylated hemoglobin (HbA1c) during the study period. Long-term Omnitrope® therapy showed slight positive effects on lipid profile, while no significant changes were observed in body weight and BMI during the study. CONCLUSION: This snapshot analysis of Italian participants in PATRO Adults confirmed the long-term safety and effectiveness of Omnitrope® in adults with GHD.
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