Abstract

BackgroundTo evaluate the impact of treatment with recombinant human growth hormone (rhGH; Omnitrope®) on the risk of diabetes mellitus in adults with growth hormone deficiency (GHD), using data from the ongoing PATRO Adults post-marketing surveillance study.MethodsPATRO Adults is an ongoing post-marketing surveillance study being conducted in hospitals and specialized endocrinology clinics across Europe. All enrolled patients who receive ≥1 dose of Omnitrope® are included in the safety population. Patient profiles, containing all available study database information for each specific patient, were generated for all patients with adverse events (AEs) of diabetes mellitus while participating in the study. Diabetes mellitus was confirmed if fasting plasma glucose was ≥7.0 mmol/L or 2-h plasma glucose ≥11.1 mmol/L during oral glucose tolerance test or glycated hemoglobin ≥6.5%.ResultsUp to July 2018, 1293 patients had been enrolled in the study, and 983 (76.0%) remained active. Just under half (n = 687, 49.3%) of the patients were growth hormone (GH) treatment-naïve on entering the study, and most (n = 1128, 87.2%) had multiple pituitary hormone deficiency (MPHD). Diabetes mellitus/inadequate control (worsening) of diabetes mellitus was reported in 21 patients (22 events). The cases were newly diagnosed in 15 patients (age 29–84 years; incidence rate 3.61 per 1000 patient-years) and occurred in 6 patients with pre-existing diabetes mellitus at baseline (age 45–72 years). Most cases of newly diagnosed diabetes mellitus occurred in patients with adult-onset MPHD (n = 13); the remaining cases of new-onset diabetes mellitus occurred in a patient with childhood-onset MPHD who had previously received GH replacement therapy (n = 1), and a patient with adulthood-onset isolated GHD who was naïve to GH replacement therapy (n = 1). All cases of inadequate control/worsening of diabetes mellitus occurred in patients with adult-onset MPHD.ConclusionsBased on this snapshot of data from PATRO Adults, Omnitrope® treatment is tolerated in adult patients with GHD in a real-life clinical practice setting. No signals of an increased risk for diabetes mellitus have been noted so far, although continued follow-up (both during and after rhGH therapy) is required to confirm this.Trial registrationNot applicable.

Highlights

  • To evaluate the impact of treatment with recombinant human growth hormone on the risk of diabetes mellitus in adults with growth hormone deficiency (GHD), using data from the ongoing PAtients TReated with Omnitrope® (PATRO) Adults post-marketing surveillance study

  • Beck-Peccoz et al BMC Endocrine Disorders (2019) 19:138 (Continued from previous page). Based on this snapshot of data from PATRO Adults, Omnitrope® treatment is tolerated in adult patients with GHD in a real-life clinical practice setting

  • PAtients TReated with Omnitrope® (PATRO) Adults is an ongoing post-marketing surveillance study conducted in hospitals and specialized endocrinology clinics across Europe [12]

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Summary

Introduction

To evaluate the impact of treatment with recombinant human growth hormone (rhGH; Omnitrope®) on the risk of diabetes mellitus in adults with growth hormone deficiency (GHD), using data from the ongoing PATRO Adults post-marketing surveillance study. Growth hormone deficiency (GHD) is a well-recognized condition in adults, with an estimated prevalence of 2–3 per 10,000 population [1]. Adult GHD has been associated with impaired lipid and carbohydrate metabolism, and an increased risk of cardiovascular complications, partly due to increased visceral obesity [3, 4]. Growth hormone (GH) is involved in the regulation of glucose levels, and impaired glucose metabolism, insulin resistance, and fasting hyperinsulinemia have been reported in adult patients with GHD [4, 5]. The prevalence of diabetes mellitus in adult GHD patients is significantly increased compared with the general population [7], in those with additional risk factors such as a family history of diabetes mellitus or obesity [8]

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