Long-term Effectiveness and Safety of GH Replacement Therapy in Adults ≥60 Years: Data From NordiNet® IOS and ANSWER

Beverly M K Biller; Charlotte Höybye; Jean-Marc Ferran; Nicky Kelepouris; Navid Nedjatian; Anne Helene Olsen; Matthias M Weber; Murray B Gordon

doi:10.1210/jendso/bvad054

Long-term Effectiveness and Safety of GH Replacement Therapy in Adults ≥60 Years: Data From NordiNet® IOS and ANSWER

J Endocr Soc. 2023 Apr 26;7(6):bvad054. doi: 10.1210/jendso/bvad054. eCollection 2023 May 5.

Authors

Beverly M K Biller¹, Charlotte Höybye², Jean-Marc Ferran³, Nicky Kelepouris⁴, Navid Nedjatian⁵, Anne Helene Olsen⁶, Matthias M Weber⁷, Murray B Gordon⁸

Affiliations

¹ Neuroendocrine Unit-Bulfinch 457B, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114, USA.
² Department of Endocrinology and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, 171 76 Stockholm, Sweden.
³ Qualiance ApS, Oehlenschlægersgade 4, 2, 1663 Copenhagen V, Denmark.
⁴ US Medical Affairs-Rare Endocrine Disorders, Novo Nordisk Inc, Plainsboro, NJ 08536, USA.
⁵ Global Medical Affairs-Rare Endocrine Disorders, Novo Nordisk Health Care AG, 8050 Zurich, Switzerland.
⁶ Epidemiology, Novo Nordisk A/S, 2860 Søborg, Denmark.
⁷ Unit of Endocrinology, Medical Department, University Hospital, Universitätsmedizin Mainz, der Johannes Gutenberg-Universität, Langenbeckstraße 1, 55131 Mainz, Germany.
⁸ Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, Pittsburgh, PA 15212, USA.

Abstract

Context: Effectiveness and safety data on GH replacement therapy (GHRT) in older adults with adult GH deficiency (AGHD) are limited.

Objective: To compare GHRT safety and clinical outcomes in older (≥60 years and, for some outcomes, ≥75 years) and middle-aged (35-<60 years) patients with AGHD.

Design/setting: Ten-year follow-up, real-world data from 2 large noninterventional studies-NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program-were analyzed.

Patients: GH-naïve and non-naïve patients with AGHD.

Intervention: Norditropin® (somatropin).

Main outcome measures: Outcomes included GH exposure, IGF-I standard deviation scores (SDS), body mass index (BMI), glycated hemoglobin (HbA_1c), serious and nonserious adverse reactions (SARs and NSARs, respectively), and serious adverse events (SAEs). Adverse reactions were events with possible/probable causal relationship to GHRT.

Results: The effectiveness analysis set comprised 545 middle-aged and 214 older patients (19 aged ≥75 years) from NordiNet® IOS. The full analysis set comprised 1696 middle-aged and 652 older patients (59 aged ≥75 years) from both studies. Mean GH doses were higher in middle-aged vs older patients. For both age groups and sexes, mean IGF-I SDS increased following GHRT, while BMI and HbA_1c changes were similar and small.Incidence rate ratios (IRRs) did not differ statistically between older and middle-aged patients for NSARs [IRR (mean, 95% confidence interval) 1.05 (.60; 1.83)] or SARs [.40 (.12; 1.32)]. SAEs were more frequent in older than middle-aged patients [IRR 1.84 (1.29; 2.62)].

Conclusion: Clinical outcomes of GHRT in AGHD were similar in middle-aged and older patients, with no significantly increased risk of GHRT-related adverse reactions in older patients.

Keywords: IGF-I SDS; adult growth hormone deficiency; elderly; growth hormone replacement therapy; older age; somatropin.