ECE2022 Eposter Presentations Pituitary and Neuroendocrinology (211 abstracts)
Growth hormone (GH) replacement therapy (GHRT) in patients with adult GH deficiency (AGHD) aged ≥60 years: data from NordiNet® IOS and the ANSWER Program
Matthias M. Weber 1 , Murray B. Gordon 2 , Charlotte Höybye 3 , Anne H. Olsen 4 , Nicky Kelepouris 5 , Navid Nedjatian 6 & Beverly M.K. Biller 7
1University Hospital, Universitätsmedizin Mainz, der Johannes Gutenberg-Universität, Unit of Endocrinology, Medical Department, Mainz, Germany; 2Allegheny General Hospital, Allegheny Neuroendocrinology Center, Division of Endocrinology, Pittsburgh, United States; 3Karolinska University Hospital and Karolinska Institute, Department of Endocrinology and Department of Molecular Medicine and Surgery, Stockholm, Sweden; 4Novo Nordisk A/S, Epidemiology, Søborg, Denmark; 5Novo Nordisk Inc, US Medical Affairs – Rare Endocrine Disorders, Plainsboro, United States; 6Novo Nordisk Health Care AG, Global Medical Affairs – Rare Endocrine Disorders, Zurich, Switzerland; 7Massachusetts General Hospital, Neuroendocrine Unit, Boston, United States
Introduction: There are limited data on the effectiveness and safety of GHRT in older patients with AGHD. We compared real-world GHRT outcomes in older (aged ≥60 years) vs middle-aged (35–<60 years) adults.
Methods: NordiNet® IOS (NCT00960128) and ANSWER (NCT01009905) were non-interventional studies investigating long-term effectiveness and safety of GHRT with Norditropin® (somatropin, Novo Nordisk). Safety was assessed in the full analysis set (FAS) from both studies (non-GH-naïve patients included). The effectiveness analysis set (EAS) was from NordiNet® IOS only (GH-naïve patients; ANSWER-EAS included patients previously treated for ≤6 months). Serious adverse reactions (SARs) and non-serious adverse reactions (NSARs) with a suspected causal relationship to GHRT, and serious adverse events (SAEs) not considered related to GHRT, are presented as incidence rates per 1000 patient-years and as incidence rate ratios (IRRs) for older vs middle-aged adults.
Results: Baseline characteristics are shown (table). Mean GH exposure was greater in women than men, and in middle-aged than older women (FAS); it increased slightly over time in all groups. Baseline IGF-I SDS was slightly higher in older vs middle-aged women, but not men (EAS). Mean IGF-I SDS increased from below 0 to values ≤1.24 with GHRT. Mean changes in BMI (EAS) and HbA1c (EAS and FAS) were small and similar between age groups in both sexes. No statistically significant differences were observed between older and middle-aged adults regarding incidence rates for NSARs (5.66 vs 5.38; IRR [mean, 95%CI] 1.051 [0.604;1.831]) and SARs (1.00 vs 2.52; IRR 0.396 [0.119;1.324]). As expected, SAE incidence rate (considered unrelated to GHRT) was higher in the older group (16.64 vs 9.04, IRR 1.840 [1.291;2.622]). Similarly, the IRRs of patients ≥75 years (n=59) vs the middle-aged group were only significant for SAEs (23.09 vs 9.04; IRR 2.553 [1.113;5.855]).
| EAS | FAS | |||
| 35–<60 years(n=545) | ≥60 years (n=214) | 35–<60 years (n=1696) | ≥60 years (n=652) | |
| Female, % | 45.9 | 39.3 | 52.4 | 43.3 |
| Age, years | 48.51 (6.98) | 67.16 (4.89) | 48.43 (7.05) | 67.09 (5.13) |
| GH dose, mg/day | 0.24 (0.16) | 0.20 (0.10) | 0.32 (0.24) | 0.26 (0.18) |
| IGF-I SDS | −0.94 (1.40) | −0.82 (1.36) | −0.58 (1.53) | −0.27 (1.54) |
| BMI, kg/m2 | 29.29 (6.09) | 28.95 (4.58) | 30.50 (7.26) | 29.42 (5.39) |
| Duration of follow-up, years | 5.37 (4.28) | 5.28 (3.92) | 5.19 (4.50) | 4.65 (3.86) |
Conclusion: These data suggest similar clinical outcomes with GHRT in patients with AGHD aged ≥60 compared with 35–<60 years without additional risk of adverse drug reactions in older patients. Baseline characteristics (mean [SD] except for sex).
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