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 language | English (US) |
|---|---|
| Pages (from-to) | 71-82 |
| Number of pages | 12 |
| Journal | Growth Hormone and IGF Research |
| Volume | 50 |
| DOIs | |
| State | Published - Feb 2020 |
Funding
MMW has received honoraria for participation in advisory boards and as a speaker from Novartis, Ipsen and Novo Nordisk, and research grants from Ipsen and Novartis. MBG reports grants from Corcept, Crinetics, Ipsen, Novo Nordisk, Opko and Teva. CH has been an investigator for Ascendis Pharma A/S, Handok-Genexine, Novo Nordisk, Sandoz, Teva, and Versatis, and has consulted for Novo Nordisk, Sandoz and Teva. JOJ reports grants and personal fees from Pfizer, and personal fees from Novo Nordisk, and Sandoz. GP was an employee of Novo Nordisk at the time of the study. VO and AP are employees of Novo Nordisk. VPB reports personal fees lectures from Novartis, Novo Nordisk, Pfizer and Sandoz. MEM reports grants and personal fees from Novo Nordisk, personal fees from Corcept, Janssen, Merck, and Pfizer, and grants from Novartis. NH has nothing to disclose. BMKB reports grants and personal fees from Novo Nordisk, personal fees from Aeterna Zentaris, personal fees from Ascendis, Ferring, Merck Serono, OPKO, and Sandoz. NordiNet® IOS was designed by the sponsor, Novo Nordisk A/S. The ANSWER study was designed by Novo Nordisk Inc.The authors would like to thank the patients, their families, the nurses and study coordinators and all investigators involved in this study. Statistical support was provided by Jean-Marc Ferran of Qualiance ApS, supported by Novo Nordisk Health Care AG. Medical writing and editorial support were provided by Penny Butcher, PhD, and Richard McDonald, BSc, of Watermeadow Medical, part of the Ashfield Group, supported by Novo Nordisk Health Care AG. The sponsor was involved in the study design, collection, analysis and interpretation of data, as well as data checking of information provided in the manuscript. However, ultimate responsibility for opinions, conclusions, and data interpretation lies with the authors. The authors would like to thank the patients, their families, the nurses and study coordinators and all investigators involved in this study. Statistical support was provided by Jean-Marc Ferran of Qualiance ApS, supported by Novo Nordisk Health Care AG. Medical writing and editorial support were provided by Penny Butcher, PhD, and Richard McDonald, BSc, of Watermeadow Medical, part of the Ashfield Group, supported by Novo Nordisk Health Care AG . The sponsor was involved in the study design, collection, analysis and interpretation of data, as well as data checking of information provided in the manuscript. However, ultimate responsibility for opinions, conclusions, and data interpretation lies with the authors.
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