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

Autor: Biller BMK; Neuroendocrine Unit-Bulfinch 457B, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114, USA., Höybye C; Department of Endocrinology and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, 171 76 Stockholm, Sweden., Ferran JM; Qualiance ApS, Oehlenschlægersgade 4, 2, 1663 Copenhagen V, Denmark., Kelepouris N; US Medical Affairs-Rare Endocrine Disorders, Novo Nordisk Inc, Plainsboro, NJ 08536, USA., Nedjatian N; Global Medical Affairs-Rare Endocrine Disorders, Novo Nordisk Health Care AG, 8050 Zurich, Switzerland., Olsen AH; Epidemiology, Novo Nordisk A/S, 2860 Søborg, Denmark., Weber MM; Unit of Endocrinology, Medical Department, University Hospital, Universitätsmedizin Mainz, der Johannes Gutenberg-Universität, Langenbeckstraße 1, 55131 Mainz, Germany., Gordon MB; Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, Pittsburgh, PA 15212, USA.
Jazyk: angličtina
Zdroj: Journal of the Endocrine Society [J Endocr Soc] 2023 Apr 26; Vol. 7 (6), pp. bvad054. Date of Electronic Publication: 2023 Apr 26 (Print Publication: 2023).
DOI: 10.1210/jendso/bvad054
Abstrakt: 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.
(© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.)
Databáze: MEDLINE