According to a study published in the Journal of Cardiovascular Pharmacology and Therapeutics, long-term testosterone therapy may have protective cardiovascular (CV) effects in men with hypogonadism.
Given the lack of substantial evidence regarding the safety and risk of testosterone therapy and CV outcomes, researchers from Boston University Schools of Medicine (BUSM) and Public Health (BUSPH), along with researchers in Germany, set up a registry to evaluate long-term efficacy and safety of testosterone in men.
The observational, prospective, cumulative registry study included 656 men with total testosterone levels ≤12.1nmol/L with symptoms of hypogonadism. The treatment group received parenteral testosterone undecanoate 1000mg every 12 weeks after an initial 6-week interval for up to 10 years. The control group consisted of male patients who opted against testosterone therapy. The average follow-up for both groups was 7 years.
Researchers obtained measurements at least twice a year and analyzed 8-year data. Baseline differences between the two groups were accounted for with adjustments made for age, blood pressure, fasting glucose, lipids, weight, and waist circumference.
In the testosterone treatment group, two deaths were reported, none of which were related to CV events. In the control group, 21 deaths were reported, of which 19 were related to CV events.
The incidence of death was 0.1145 per 10 patient-years in the control group (95% CI: 0.0746-0.1756; P<0.000) vs. 0.0092 per 10 patient-years in the testosterone group (95% CI: 0.0023–0.0368; P<0.000); the estimated difference was 0.0804 (95% CI: .0189-0.3431; P<0.001). Study authors also reported the estimated reduction in mortality for the testosterone-treatment group was between 66% and 92%. The control group reported 30 nonfatal strokes and 26 nonfatal myocardial infarctions whereas none were reported in the testosterone group.
“The low CV events observed in the [testosterone]-group compared to the untreated (control) group strongly suggest that [testosterone therapy] is protective. We believe that the protective effect of [testosterone] on the CV system provides clinicians with the opportunity to utilize this approach for secondary prevention for hypogonadal men with a history of CV events,” explained corresponding author Abdulmaged M. Traish, PhD, professor of biochemistry and urology at BUSM.
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