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Erectile function improves in hypogonadal men with type 2 diabetes under long-term testosterone therapy: real-world evidence from a urological registry study

Saad, F1; Haider, KS2; Doros, G3; Traish, A4; Haider, A2

1: Bayer AG, Germany; 2: Private Urology Practice, Germany; 3: Boston University School of Public Health, USA; 4: Boston University School of Medicine, USA

Objectives: Erectile dysfunction affects the majority of patients with type 2 diabetes (T2DM) and remains difficult to treat. Hypogonadism is highly prevalent in men with T2DM. We investigated effects of testosterone therapy (TTh) in hypogonadal men with T2DM in a urological office.

Material and Methods: 133 men with T2DM, testosterone ≤12.1 nmol/L and hypogonadal symptoms received testosterone undecanoate 1000 mg every 3 months following an initial 6-week interval for up to 10 years. 153 hypogonadal men with T2DM decided against TTh and served as controls. Measurements were performed 1-4 times a year and included IIEF-EF (5+1, maximum score: 30), fasting glucose, HbA1c, insulin, and HOMA-IR. Differences between groups were estimated and adjusted for age and metabolic syndrome parameters to account for baseline differences between groups.

Results: Mean age: 63±5 years (T-group: 62±5, CTRL: 64±5). IIEF-EF increased from 18.3±5.4 to 27±2 in the T-group and declined from 19.8±3.3 to 9±2.1 in CTRL, between-group difference: 19.7 (p<0.0001 for all). Fasting glucose decreased from 7.6±1.1 to 5.3±0.1 mmol/L in the T-group and increased from 6.2±0.6 to 6.9±1.0 mmol/L in CTRL, between-group difference: -2.2 mmol/L (p<0.0001 for all). HbA1c decreased from 8.8±0.9 to 5.9±0.3% at 10 years in the T-group and increased from 7.7±0.6 to 9.5±0.9% in CTRL, between-group difference: -4.6% (p<0.0001 for all). Fasting insulin decreased from 29.6±4.2 to 15±4.8 µU/mL in the T-group and increased in CTRL from 26.5±2.6 to 37 µU/mL, between-group difference: -23.1 µU/mL (p<0.0001 for all). HOMA-IR decreased from 10.2±2.0 to 3.6±1.2 in the T-group and increased in CTRL from 7.4±1.4 to 11.4, between-group difference: -9.4 mmol/L (p<0.0001 for all). At baseline, 54 patients in the T-group received insulin at a mean dose of 32.4±12.1 units/day. Mean dose requirement declined to 20.6±11.3 units. In CTRL, 55 patients received insulin at a mean dose of 29.4±5 units/day with an increase of mean dose requirement to 39.5±7.2 units, estimated adjusted difference between groups: -25.7 units/day (p<0.0001).

Conclusions: Erectile function in men with T2DM improved sustainably under long-term TTh and progressed in untreated hypogonadal controls. Testosterone should be measured routinely and TTh offered to men with T2DM when indicated, according to guidelines of the American Association of Clinical Endocrinologists (AACE).

Disclosure:

Work supported by industry: yes, by Bayer AG (industry funding only - investigator initiated and executed study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

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