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Reduction of major adverse cardiovascular events (MACE) and improvement of erectile function in hypogonadal men receiving testosterone therapy – real-life evidence from a registry study

Saad, F1Haider, KS2; Haider, A2; Doros, G3; Traish, A4

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 is a risk factor and predictor of cardiovascular disease. To investigate long-term effects up to 10 years of testosterone therapy (TTh) in an unselected cohort of hypogonadal men on erectile function, anthropometric parameters, and major adverse cardiovascular events.

Material and Methods: 400 men with testosterone ≤12.1 nmol/L and hypogonadal symptoms of hypogonadism received testosterone undecanoate 1000 mg every 3 months for up to 10 years (T-group). 376 hypogonadal men decided against testosterone therapy (CTRL). Median follow-up: 8 years. Weight and waist circumference were measured at baseline and then every 3-6 months in treated and every 6-12 months in untreated patients. Erectile function and quality of life were assessed by questionnaires (IIEF-EF and AMS). Differences between groups were estimated and adjusted for age and metabolic syndrome components.

Results: Mean age: 61±7 years (T-group: 58±7, CTRL: 64±5). IIEF-EF increased from 18.7±5.4 to 26.9±1.8 in the T-group and decreased from 20.1±3.1 to 9.4±1.6 in CTRL, between-group difference: 18.3 (p<0.0001 for all). Waist circumference decreased from 106±9 to 96±6 cm at 10 years in the T-group and from 110±11 to 109±9 cm in CTRL, estimated adjusted between-group difference: -12 cm (p<0.0001 for all). Weight decreased from 104±17 to 86±8 kg in the T-group (p<0.0001) and increased slightly from 94±12 to 94.3±10 in CTRL (p<0.0005), between-group difference: -20 kg (p<0.0001). The per cent weight change at 10 years was -18.7±7.3% in the T-group (p<0.0001) vs +2.7±4% in CTRL (p<0.01), between-group difference: -19.5% (p<0.0001). AMS improved from 51.2±9.8 to 17.1±0.2 in the T-group and worsened from 40.1±5.5 to 57.3±3 in CTRL, between-group difference: -40.4 (p<0.0001 for all). Major adverse cardiovascular events (MACE): in CTRL, there were 39 deaths (10.4%), 45 myocardial infarctions (12%), and 42 strokes (11.2%). There were 6 deaths (1.5%) but no major cardiovascular events in the T-group. Medication adherence in the T-group was 100 per cent as all injections were performed in the office and documented.

Conclusions: Erectile function and anthropometric measures improved in a sustainable fashion in the T-group and worsened (IIEF-EF) or remained largely stable in CTRL. These improvements may have contributed to reducing MACE in hypogonadal men receiving adequate TTh.


Work supported by industry: yes, by Bayer AG (industry funding only - investigator initiated and executed study).

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