Background: Men with hypogonadism are at increased risk of MACE and mortality. Studies in men with T2DM show that testosterone therapy (TTh) reduces both MACE and mortality.

Methods: Of 361 men with hypogonadism and T2DM, 183 received testosterone undecanoate injections (TU) 1000 mg/12 weeks (T-group), 178 opted against treatment (CTRL). MACE, mortality, and diabetic complications were recorded and compared between groups.

Results: Mean baseline age in the T-group and CTRL was 60.7±5.5 and 63.0±4.9 years. Mean follow-up in T-group vs. CTRL was 8.2 and 9.2 years. 70 patients (38.3%) in the T-group and 70 (39.3%) in CTRL had a history of cardiovascular disease (myocardial infarction MI, stroke, or coronary artery disease diagnosis) (p=0.8341). Baseline smoking prevalence was 41.0% (75 men) in the T-group and 38.2% (68 men) in CTRL (p=0.5161). The T-group had significantly worse baseline risk factor profile than CTRL: BMI (36.5±4.5 vs. 33.4±5.3 kg/m2), systolic blood pressure (163.0±13.5 vs. 145.6±14.6 mmHg), LDL (4.7±0.9 vs. 4.1±1.4 mmol/L), HbA1c 9.4±1.4 vs. 7.8±0.7% (p<0.0001 for all). Mortality: during the entire observation period, 15 patients (8.2%) died in the T-group vs. 61 (34.3%) in CTRL (p<0.0001). Major adverse cardiovascular events (MACE): in the T-group, there were no cases of MI or stroke. In CTRL, there were 56 cases of MI (31.5%) and 56 cases of stroke (31.5%). 35 patients (19.7%) suffered a MI and a stroke. Diabetic complications: in the T-group vs. CTRL, the incidence of retinopathy was 6 (3.3%) vs. 30 (16.9%) (p<0.0001), nephropathy 1 (0.01%) vs. 5 (2.8%) (p<0.05), polyneuropathy 11 (6.0%) vs. 97 (54.5%) (p<0.0001), diabetic foot syndrome 0 (0%) vs. 10.1% (p<0.0001).

Conclusions: Long-term treatment with TU in men with hypogonadism and T2DM significantly reduces mortality, compared to untreated controls.

Disclosure

K. S. Haider: Other Relationship; Self; Bayer AG. A. Haider: Other Relationship; Self; Bayer AG. F. Saad: Consultant; Self; Bayer AG, Stock/Shareholder; Self; AbbVie Inc., Bayer AG, Novo Nordisk.

Funding

Bayer AG

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