Purpose: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope®, a somatropin biosimilar to Genotropin®, in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. Methods: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope®, which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels. Here we report the data from the Italian patients enrolled in the study. Results: Sixty-seven patients (mean age 50.4 years, 61.2% male) have been enrolled and have received a mean 45.4 ± 24.3 months of Omnitrope®. A total of 55.2% of patients were reported to have experienced adverse events (AEs), including arthralgia, myalgia, abdominal distension and hypoaesthesia, and 4.5% had adverse drug reactions. Fourteen serious AEs have been recorded; none of these are considered related to the study drug. The effectiveness of Omnitrope® was similar to other available somatropin preparations. Conclusions: This study confirms the effectiveness and safety of Omnitrope® in adult patients with GHD in Italy. However, due to the limited size of the study population, these results need to be further confirmed by the global PATRO Adults study.
Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study / D. Ferone, E. Profka, V. Gasco, M.R. Ambrosio, A. Colao, C. Di Somma, E. Puxeddu, G. Arnaldi, C. Pagano, E. Zecchi, A. Pietropoli, P. Beck-Peccoz. - In: JOURNAL OF ENDOCRINOLOGICAL INVESTIGATION. - ISSN 0391-4097. - 40:6(2017 Feb), pp. 669-678.
|Titolo:||Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study|
PROFKA, ERISELDA (Secondo)
BECK PECCOZ, PAOLO LUIGI MARIA (Ultimo)
|Parole Chiave:||Growth hormone deficiency; Hypopituitarism; Insulin-like growth factor-1; Omnitrope®; Recombinant human growth hormone; Safety; Adult; Aged; Body Height; Bone Density; Female; Growth Disorders; Human Growth Hormone; Humans; Longitudinal Studies; Male; Middle Aged; Safety; Endocrinology, Diabetes and Metabolism; Endocrinology|
|Settore Scientifico Disciplinare:||Settore MED/13 - Endocrinologia|
|Data di pubblicazione:||feb-2017|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1007/s40618-016-0604-8|
|Appare nelle tipologie:||01 - Articolo su periodico|
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