ECE2021 Oral Communications Oral Communications 13: Pituitary and Neuroendocrinology (6 abstracts)
Cardiovascular and metabolic safety of growth hormone treatment in adult patients with growth hormone deficiency: real-world data from two large studies in the USA and Europe
Charlotte Höybye 1 , Nicky Kelepouris 2 & Navid Nedjatian 3
1Karolinska University Hospital and Karolinska Institute, Department of Endocrinology, and Department of Molecular Medicine and Surgery, Stockholm, Sweden; 2Novo Nordisk Inc., Plainsboro, United States; 3Novo Nordisk Health Care AG, Zurich, Switzerland
Introduction
Evidence suggests that adults with growth hormone deficiency (AGHD) exhibit metabolic abnormalities that are typical of the metabolic syndrome and are risk factors for type 2 diabetes (T2D). Concerns about undesirable effects of growth hormone replacement therapy (GHRT) on glucose metabolism have been raised, but the risk of T2D from AGHD has mixed evidence. This analysis aims to evaluate cardiovascular (CV) and metabolic safety of GHRT in these patients in a real-world setting.
Methods
NordiNet IOS (NCT00960128) and ANSWER (NCT01009905) were observational, non-interventional studies that investigated the long-term effectiveness and safety of GHRT. This analysis includes pooled data from the AGHD population from the two studies (n = 1, 275; 50.6% female). Baseline characteristics [mean (SD)] were: age at treatment initiation, 48.5 (13.7) years; growth hormone dose, 0.3 (0.2) mg/day; and body mass index, 29.9 (7.1) kg/m2. We compared the proportion of patients with CV and metabolic risk factors above the clinical threshold at baseline and after 7 years of GHRT.
Results
The overall proportion of patients with increased CV and metabolic risk factors was not different from baseline after 7 years of follow up, except for the decrease in patients with high LDL-cholesterol (P = 0.03) and non-HDL-cholesterol (P = 0.03) (Table 1). The only statistically significant gender-specific result observed was the decrease in proportion of men with high non-HDL-cholesterol (P = 0.007).
Conclusion
GHRT in AGHD did not increase the percentage of patients with increased CV and metabolic risk factors. This analysis provides further insight into the safety of GHRT in AGHD.
| Risk factor thresholds | Patients included in this analysis N | Baseline n (%) | After 7 years n (%) | P-value* |
| FPG ≥ 126 mg/dl | 58 | 4 (6.90) | 4 (6.90) | 1.0000 |
| HbA1c ≥ 6.5% | 81 | 5 (6.17) | 6 (7.41) | 1.0000 |
| SBP ≥ 130 mm Hg | 130 | 61 (46.92) | 65 (50.00) | 0.7098 |
| DBP ≥ 80 mm Hg | 130 | 82 (63.08) | 68 (52.31) | 0.1025 |
| Total cholesterol ≥ 4.0 mmol/l | 88 | 83 (94.32) | 82 (93.18) | 1.0000 |
| LDL-cholesterol ≥ 3.0 mmol/l | 56 | 40 (71.43) | 28 (50.00) | 0.0328 |
| HDL-cholesterol < 1.0 mmol/l (men) and < 1.3 (women) | 84 | 21 (25.00) | 21 (25.00) | 1.0000 |
| Non-HDL-cholesterol ≥ 3.4 mmol/l | 82 | 65 (79.27) | 51 (62.20) | 0.0251 |
| Waist circumference ≥ 102 cm (men) and ≥ 88 cm (women) | 65 | 35 (53.85) | 27 (41.54) | 0.2189 |
| *Calculated using Fisher’s exact test | ||||
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