Effect of testosterone therapy on cardiovascular risk factors, major adverse cardiovascular events and mortality in men with functional hypogonadism and cardiovascular disease in a real-world registry

Abstract

Abstract Background Cardiovascular safety of testosterone therapy (TTh) in men with functional hypogonadism has been debated. Purpose To investigate cardiovascular risk factors and incidence of major adverse cardiovascular events (MACE) and mortality in a high-risk population in a real-world setting. Methods Of 773 men with functional (non-organic) hypogonadism in a registry study, 217 had a pre-existing cardiovascular disease. 99 men received parenteral TU 1000 mg/12 weeks following an initial 6-week interval (T-group) for up to 15 years, 118 opted against TTh and served as controls (CTRL). Most measurements were performed 2–4 times a year for approximately 1,800 patient-years. 11-year data were analysed. Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results Mean baseline age: 61.5±4.6 years (T-group), 63.9±4.9 (CTRL) (p<0.0005). 86.9% in the T-group and 61.9% in CTRL (p<0.0001) were obese at baseline. Mean BMI (kg/m2) declined by 8.3±0.4 in the T-group and increased by 2.5±0.4 in CTRL at 11 years, estimated adjusted difference between groups: −10.8 (p<0.0001 for all). Weight loss was 20.8±0.6% (T-group), weight gain 8.1±0.5% (CTRL), difference between groups: −28.8% (p<0.0001 for all). 99% in the T-group and 97.5% in CTRL (p<0.001) had hypertension at baseline. Mean systolic blood pressure (BP) (mmHg) decreased by 36.2±1.3 (T-group) and increased by 9.3±1.3 (CTRL), difference between groups: −45.5 (p<0.0001 for all). Diastolic BP decreased by 24.0±1.0 (T-group) and increased by 7.7±1.0 (CTRL), difference between groups: −31.7 (p<0.0001 for all). Lipids (mmol/L): LDL cholesterol decreased by 2.1±0.1 (T-group) and increased by 0.9±0.1 (CTRL), difference between groups: −3.0 (p<0.0001 for all). Non-HDL cholesterol decreased by 5.7±0.4 (T-group) and increased by 4.8±0.4 (CTRL), difference between groups: −10.5 (p<0.0001 for all). Remnant cholesterol decreased by 1.2±0.1 (T-group) and increased by 1.0±0.1 (CTRL), difference between groups: −2.2 (p<0.0001 for all). 67.7% in the T-group and 55.1% in CTRL (NS) had type 2 diabetes (T2DM) at baseline. HbA1c (%) decreased by 3.4±0.2 (T-group) and increased by 2.7±0.2 (CTRL), difference between groups: −6.0 (p<0.0001 for all). 29 men (24.6%) were diagnosed with T2DM during follow-up. Mortality: 13 deaths (13.1%) in the T-group. 40 (33.9%) in CTRL (p<0.0005). Non-fatal myocardial infarctions: None in the T-group, 31 (26.3%) in CTRL (py0.0001). Non-fatal strokes: None in the T-group, 29 (24.6%) in CTRL (p<0.0001). Medication adherence to testosterone was 100% as all injections were administered in the medical office and documented. Conclusions In men with functional hypogonadism, long-term TTh improves cardiovascular risk factors and reduces cardiovascular events and mortality. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer AG