Background: Hypogonadism is highly prevalent in men with T2DM.
Methods: Of 805 hypogonadal men in a urological registry, 311 men (39%) had T2DM diagnosed and treated elsewhere. 141 received TU 1000 mg/12 weeks (T-group), 170 opted against treatment (CTRL). Mean changes over time between groups were compared by mixed effects model. Changes were adjusted for age, weight, waist circumference, HbA1c, blood pressure (BP), lipids to account for baseline differences between the two groups.
Results: Mean follow-up 7.5 years for 2.319 patient-years. Age: 62.8±5.1 years. T-group: HbA1c progressively decreased from 9.0±1.2 to 5.9±0.3% at 10 years (p<0.0001) with statistical significance vs. previous year for the first 7 years. CTRL: HbA1c increased from 7.8±0.7 to 10.6±1.7% (p<0.0001). Estimated adjusted difference between groups; -6.2% (p<0.0001). T-group: fasting insulin decreased from 29.6±4.1 to 13.5±5 µU/mL (p<0.0001) with statistical significance vs. previous year for the first 6 years. CTRL: fasting insulin increased from 26.1±2.7 to 36.7±2 µU/mL (p<0.0001). Estimated adjusted difference between groups: -28 µU/mL (p<0.0001). T-group: HOMA-IR decreased from 10.2±2.1 to 3.3±1.2 after 10 years (p<0.0001). The decrease was statistically significant vs. previous year for the first 6 years. CTRL: HOMA-IR increased from 7.5±1.3 to 17.1±6.3 (p<0.0001). Estimated adjusted difference between groups: -14.8 (p<0.0001). Since injections were administered in the doctor’s office and no patient dropped out, there was a 100% adherence to TTh. 8 patients (5.7%) in T-group died. In CTRL, 47 myocardial infarctions (27.6%), 37 strokes (21.8%), and 41 deaths (24.1%) occurred.
Conclusions: Long-term TTh with TU in hypogonadal men with T2DM improved diabetic measures and reduced MACE compared to untreated controls.
F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; Bayer AG, Novo Nordisk A/S. K.S. Haider: Other Relationship; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG.