SUN-226 Improvements In Quality Of Life In Men With Hypogonadism Under Long-term Testosterone Therapy (TTh) With Testosterone Undecanoate Injections (TU): Experience From 6,500 Patient-years Ina Registry Study Ina Urological Setting

Background: Quality of life in men is influenced by general health, sexual function and urinary function. These components are associated with both weight and inflammatory status. Material and Methods: 805 men with hypogonadism are enrolled in a registry study in a urological office. 412 received TTh with TU 1000 mg/12 weeks (T-group) while 393 opted against TTh and served as controls (CTRL). 43 men (10.4%) in the T-group had Klinefelter’s syndrome and contributed to lowering the mean age of the treated group. Measurements were performed 1-4 times a year. 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 57.7±7.4 (T-group), 63.7±4.8 years (CTRL). Mean (median) follow-up: 8 (8) years (T-group) and 8 (9) years (CTRL). Total observation time: 6471 patient-years. The Aging Males’ Symptoms scale (AMS) decreased by 29.2±0.3 (p<0.0001) (T-group) and increased by 15.1±0.4 (p<0.0001) in CTRL, estimated adjusted difference between groups: 44.3 (p<0.0001). The International Index of Erectile Function - Erectile Function Domain (IIEF-EF) increased by 27.5±0.2 (p<0.0001) (T-group) and decreased by 8.0±0.2 (p<0.0001) in CTRL, difference between groups: 19.5 (p<0.0001). The International Prostate Symptom Score (IPSS) decreased by 4.6±0.1 (p<0.0001) (T-group) and increased by 2.6±0.1 (p<0.0001) in CTRL, difference between groups: 7.2 (p<0.0001). C-reactive protein (CRP) decreased by 3.9±0.1 (p<0.0001) (T-group) and by 0.8±0.2 (p<0.0001) in CTRL, difference between groups: 3.1 (p<0.0001). Per cent weight loss was 16.6±0.3% (p<0.0001) in the T-group, per cent weight gain 4.6±0.3% (p<0.0001) in CTRL, difference between groups: 21.2% (p<0.0001). Waist circumference declined by 9.9±0.2 cm (p<0.0001) (T-group) and increased by 4.4±0.2 cm (p<0.0001) in CTRL, difference between groups: 14.3 cm (p<0.0001). Adverse events: During the entire observation time, there were 16 deaths (3.9%) in the T-group. In CTRL, there were 74 deaths (18.8%), 70 MIs (17.8%) and 59 strokes (15%). Incident prostate cancer was diagnosed in 13 men (3.2%) in the T-group and in 27 (6.9%) in CTRL. Medication adherence in the T-group was 100 per cent as all TU-injections were performed in the office and documented. Conclusion: Long-term TTh in men with hypogonadism resulted in improvements of different aspects of quality of life. These improvements may have been mediated by weight loss and improved inflammatory status. Mortality and major adverse cardiovascular events were reduced in the T-group compared to untreated men with hypogonadism.