Safety and effectiveness of Omnitrope® in patients with growth hormone deficiency: snapshot analysis of PATRO Adults study in the Italian population.

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.

journal_name

J Endocrinol Invest

authors

Arosio M,Arnaldi G,Gasco V,Giavoli C,Puxeddu E,Vettor R,Ambrosio MR,Gallinari P,Zouater H,Fedeli P,Ferone D

doi

10.1007/s40618-020-01308-3

subject

Has Abstract

pub_date

2021-02-01 00:00:00

pages

327-337

issue

2

eissn

0391-4097

issn

1720-8386

pii

10.1007/s40618-020-01308-3

journal_volume

44

pub_type

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