(396) Effects of Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity on Weight, Waist Circumference, and Erectile Function – Results from a Registry Study

Abstract

Abstract Introduction Obesity is a risk factor for erectile dysfunction (ED). Long-term testosterone therapy (TTh) has been shown to improve anthropometric parameters as well as erectile function. Objective to investigate effects of long-term TTh up to 13 years in men with functional hypogonadism and obesity compared to an untreated control group. Methods In an ongoing registry study in men with hypogonadism (total testosterone ≤350 ng/mL and at least moderate symptoms on the Aging Males’ Symptoms scale, AMS) in a single urology office, 491 men had functional hypogonadism and obesity (BMI ≥30 kg/m2). 292 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 199 opted against TTh and served as controls (CTRL). Weight, waist circumference, and IIEF-EF (5+1 questions, maximum score: 30) were assessed at each visit. Absolute measures with standard deviations (SDs) as well as changes over time, adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids, and quality of life to account for baseline differences between groups, are reported for a duration of 13 years. Results Mean (median) follow-up: T-group 10.1±3.1 (11), CTRL 9.4±3.3 (10) years, total observation time: T-group 2944, CTRL 1861 patient-years. Baseline age was 59.5±6.0 (T-group) and 63.0±5.0 years (CTRL) (p<0.0001). In the T-group, 35.3%, 44.9% and 19.9% had obesity class I (BMI 30.0-34.4), II (BMI 35.0-39.9) and III (BMI ≥40 kg/m2), respectively. In CTRL, 71.9%, 22.1%, and 6%, had obesity class I, II, and III, respectively. At baseline, PDE5-Inhibitors were used by 25.0% (T-group) and 25.6% (CTRL) (p=0.875). T-group: weight (kg) decreased by 23.9±0.4 (least squares means ± standard errors) from 114.5±11.8 to 87.5±6.7 (means ± standard deviations) after 13 years. CTRL: weight increased by 8.4±0.6 from 105.6±10.5 to 107.9±6.2 (p<0.0001 for all). T-group: waist circumference (cm) decreased by 13.8±0.3 (least squares means ± SEs) from 115.0±13.2 to 97.5±4.6 (means ± SDs) after 13 years CTRL: waist circumference increased by 9.3±0.4 from 118.6±11.4 to 121.2±6.1 (p<0.0001 for all). T-group: BMI (kg/m2) decreased by 7.7±0.1 (least squares means ± SEs) from 36.8±3.6 to 28.3±2.1 after 13 years CTRL: BMI increased by 2.7±0.2 from 33.9±3.3 to 34.9±2.2 (p<0.0001 for all). Per cent weight loss from baseline was 22.8±4.9% in the T-group, per cent weight gain was 8.4±3.7% in CTRL (p<0.0001 for both). In the T-group, 118 patients (40.4%) achieved weight loss of ≥20% after a mean observation time of 92 months (minimum: 27, maximum: 189). No patient in CTRL achieved weight loss of ≥20%. 290 men (99.3%) in the T-group vs. 8 men (4.0%) in CTRL achieved weight loss of ≥5%. T-group: IIEF-EF increased by 11.4±0.3 (least squares means ± SEs) from 17.2±5.9 (means ± SD) at baseline to 29.4±1.0 after 13 years. CTRL: IIEF-EF decreased by 15.1±0.4 from 19.0±3.9 at baseline to 7.0±1.0 after 13 years (p<0.0001 for all). Conclusions Long-term TTh in men with functional hypogonadism and obesity improved weight, waist circumference and erectile function. In the untreated control group, anthropometric measures and erectile function deteriorated. Disclosure Yes, this is sponsored by industry/sponsor: Bayer AG, Berlin, Germany Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Bayer AG