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Observational Study
. 2017 Jun;40(6):669-678.
doi: 10.1007/s40618-016-0604-8. Epub 2017 Feb 4.

Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study

D Ferone  1 , E Profka  2 , V Gasco  3 , M R Ambrosio  4 , A Colao  5 , C Di Somma  6 , E Puxeddu  7 , G Arnaldi  8 , C Pagano  9 , E Zecchi  10 , A Pietropoli  11 , P Beck-Peccoz  12
Affiliations
Observational Study

Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study

D Ferone et al. J Endocrinol Invest. 2017 Jun.

Erratum in

Abstract

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.

Keywords: Growth hormone deficiency; Hypopituitarism; Insulin-like growth factor-1; Omnitrope®; Recombinant human growth hormone; Safety.

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Conflict of interest statement

P. Beck-Peccoz is a member of the PATRO Adults Monitoring Committee supported by Sandoz; E. Zecchi and A. Pietropoli are employees of Sandoz; all the other Authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Change in a fasting glucose and b glycosylated haemoglobin (HbA1c) in the total safety analysis set over the study period
Fig. 2
Fig. 2
Change in a fasting high-density lipoprotein (HDL) cholesterol and fasting low-density lipoprotein (LDL) cholesterol and b the ratio of HDL cholesterol and LDL cholesterol in the total safety analysis set over the study period
Fig. 3
Fig. 3
Change in a insulin-like growth factor-1 (IGF-1) and b IGF-1 standard deviation scores (IGF-1 SDS) in treatment naïve patients included in the efficacy analysis set over the study period
See this image and copyright information in PMC

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