Abstract
Introduction
Guidelines by the ESC and EASD state that patients with diabetes have a two-fold excess risk of vascular outcomes. An increasing number of studies suggests that testosterone therapy (TTh) has cardiometabolic benefits in men with hypogonadism and type 2 diabetes (T2DM).
Methods
In a registry of men with hypogonadism in a urological office, 361 men had T2DM and received standard diabetes treatment including lifestyle recommendations and coaching in a diabetes center. 183 men received TTh with testosterone undecanoate injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 178 men opted against TTh and served as controls (CTRL). Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. 12-year analyses of 3149 patient-years are reported.
Results
Mean (median) follow-up 8.2±3.2 (8) years in the T-group, 9.2±2.8 (10) years in CTRL, baseline age: 60.6±5.4 (T-group) and 63.5±5.0 (CTRL) years (p<0.0001). All but 7 patients were overweight or obese.
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).
HbA1c progressively decreased by 3.7±0.2% at 12 years in the T-group and increased in CTRL by 3.2±0.2%, estimated adjusted difference between groups: −6.9% [95% CI: −7.4; −6.4] (p<0.0001 for all).
Fasting glucose decreased in the T-group by 1.9±0.1 and increased in CTRL by 1.8±0.1 mmol/L, estimated adjusted difference: −3.6 mmol/L [95% CI: −4.0; −3.3] (p<0.0001 for all).
Men in the T-group lost 19.7±0.4% weight, men in CTRL gained 9.1±0.4%, estimated adjusted difference: −28.8% [95% CI: −30.2; −27.4] (p<0.0001 for all).
During the observation period, 15 patients (8.2%) died in the T-group vs. 61 (34.3%) in CTRL (p<0.0001).
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.
Medication adherence to testosterone was 100% as all injections were administered in the medical office and documented.
Conclusions
Long-term treatment with TU in men with hypogonadism and T2DM significantly reduces mortality, compared to untreated controls. Improved glycaemic control and weight loss may have contributed to these outcomes.
FUNDunding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Bayer AG, Berlin, Germany
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