PD24-12\u2003URINARY AND ERECTILE FUNCTION IMPROVEMENTS IN HYPOGONADAL MEN WITH TYPE 2 DIABETES (T2DM) TREATED UP TO 10 YEARS WITH TESTOSTERONE IN COMPARISON TO AN UNTREATED CONTROL GROUP

Abstract

INTRODUCTION AND OBJECTIVES: The high prevalence of hypogonadism in men with T2DM has caused the American Diabetes Association to recommend measuring testosterone in these patients in their 2018 guidelines. T2DM in men is associated with both erectile dysfunction and lower urinary tract symptoms (LUTS). We investigated effects of long-term testosterone therapy (TTh) in hypogonadal men with T2DM in a urological office compared to untreated controls. METHODS: In a registry study in 805 hypogonadal men, 311 men (38.6%) had T2DM. 141 received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 170 men opted against TTh and served as controls (CTRL). 10-year data are presented. Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. RESULTS: Mean age at baseline: 63±5 years (T-group: 62±5, CTRL: 64±5). Mean [median] follow-up: 7.5±2.5 [8] years (T-group: 7.2±2.8 [8], CTRL: 7.7±2.2 [8]). In the T-group, IPSS decreased by 5.9±0.3 [95% CI: -6.4;-5.4] at 10 years (p<0.0001). The improvement was statistically significant vs. previous year for 6 years and significant vs baseline throughout the observation time. In CTRL, IPSS increased by 1.9±0.3 [95% CI: 1.4;2.4] at 10 years (p<0.0001) with statistical significance vs. previous year for 5 years. Estimated adjusted difference between groups at 10 years: 7.8 [95% CI: -8.6;-6.9] (p<0.0001). Residual bladder volume in the T-group decreased by 51±2 mL [95% CI: -56;-46] at 10 years (p<0.0001) and increased in CTRL by 30±2 mL [95% CI: 25;35]. In the T-group, IIEF-EF (maximum score: 30) increased by 8.4±0.4 [95% CI: 7.7;9.1] at 10 years (p<0.0001). The improvement was statistically significant vs. previous year for 9 years and significant vs baseline throughout the observation time. In CTRL, IIEF-EF declined by 12.8±0.3 [95% CI: -13.5;-12.1] at 10 years (p<0.0001) with statistical significance vs. previous year for 10 years. The estimated adjusted difference between groups at 10 years: 21.2 [95% CI: 20;22.4] (p<0.0001). Diabetes and weight control: In the T-group, HbA1c dropped by 2.9±0.1% [95% CI: -3.2;-2.7] (p<0.0001) while in CTRL patients it increased by 3.2±0.1% [95% CI: 3;3.5] (p<0.0001) with statistical significance vs. previous year for 7 years (T-group) and 10 years (CTRL), respectively. In the T-group, men lost 19±0.4% weight [95% CI: -19.8;-18.2] (p<0.0001) while CTRL patients gained 4.8±0.4% [95% CI: 4.1;5.6] (p<0.0001) with statistical significance vs. previous year for 9 years (T-group) and 10 years (CTRL), respectively. Adherence to testosterone was 100% as all injections were administered in the office and documented. No patient dropped out. CONCLUSIONS: In hypogonadal men with T2DM, TTh improves and preserves urinary and erectile function for a prolonged period of time. Long-term testosterone therapy results in improved glycemic control and weight loss. Source of Funding: Bayer provided partial funding for data entry and statistical analyses.