Growth hormone replacement in adults: Real-world data from two large studies in US and Europe

Matthias M. Weber*, Murray B. Gordon, Charlotte Höybye, Jens Otto L. Jørgensen, Gediminas Puras, Vera Popovic-Brkic, Mark E. Molitch, Vlady Ostrow, Natalia Holot, Alberto Pietropoli, Beverly M.K. Biller

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Objective: This report describes the effectiveness and safety of growth hormone replacement in 3180 adult patients with growth hormone deficiency followed-up for 0.0–12.2 years in two completed, complementary, non-interventional, multicentre studies, NordiNet® International Outcome Study (IOS) (NCT00960128) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program (NCT01009905). Design: In both studies, Norditropin® (somatropin; Novo Nordisk A/S, Denmark) was administered at the discretion of the treating physician and according to routine practice. We present data on baseline characteristics, growth hormone dose, safety data and change from baseline in waist circumference, body mass index and bioimpedance (NordiNet® IOS only). Results: Mean (SD) baseline characteristics (effectiveness analysis set) in NordiNet® IOS (n = 971) and ANSWER (n = 304): females, 45%; 69%; mean growth hormone dose (mg/day) (female, 0.338 [0.177]; male, 0.289 [0.157]); (female, 0.501 [0.313]; male, 0.505 [0.351]). Most patients had BMI ≥25 kg/m2. Median (P10,P90) exposure (females, 3.5 [0.42,11.0]; 1.6 [3.2; 0.3,8.6]; males, 4.1 [0.33,10.8]; 2.3 [2.9; 0.0,7.5] years). Mean (SD) change from baseline for waist circumference (−0.46 [6.38] cm [n = 403], BMI (0.30 [3.30] kg/m2 [n = 857]) and bioimpedance (−17.4 (59.19) ohm [n = 239]) were associated with growth hormone dose (waist/bioimpedance) and duration of follow-up (BMI/bioimpedance). No new safety signals were observed among patients in the full analysis set (NordiNet® IOS, n = 2321; ANSWER, n = 859). Conclusions: Long-term growth hormone replacement is associated with an improvement in body composition. The accumulated data from >10 years of follow-up support the long-term effectiveness and safety of growth hormone replacement as prescribed in clinical practice.

Original languageEnglish (US)
Pages (from-to)71-82
Number of pages12
JournalGrowth Hormone and IGF Research
Volume50
DOIs
StatePublished - Feb 2020

Keywords

  • ANSWER Program
  • Body composition
  • Effectiveness
  • Growth hormone deficiency in adults
  • Growth hormone replacement
  • IGF-I SDS
  • NordiNet® International Outcome Study (IOS)
  • Real-world data
  • Safety

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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