Study: Testosterone Therapy Doesn't Increase VTE Risk

New research finds that testosterone replacement therapy (TRT) did not increase venous thromboembolism (VTE) risk, regardless of the window of exposure or how the therapy was administered.

A team led by Jacques Baillargeon, PhD, an associate professor in preventive medicine and community health at the University of Texas Medical Branch, identified 7,643 male patients who had an episode of VTE—either deep vein thrombosis or pulmonary embolism—and had been given at least 1 prescription for an anticoagulant or a vena cava filter within 60 days of receiving a VTE diagnosis. The authors note that each patient with a VTE was matched with 3 control patients who didn’t develop VTE during the study period.
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In their analysis, Baillargeon and colleagues found that exposure to testosterone—which they defined as at least 1 day of overlap between the most recent prescription period and the 15-day period before the VTE—within 15 days of a VTE was linked to an odds ratio for VTE of 0.90 compared to men in the control group. Overall, those who received testosterone within 15 days of a VTE demonstrated what the investigators described as a “non-significant” 10% lower risk than those who had not received supplemental testosterone. Increasing the exposure window by 30 or 60 days did not greatly affect VTE risk, the authors added.

Noting that this is the “first large-scale comparative study assessing whether testosterone therapy is associated with VTE,” Baillargeon says that “our finding of no association between testosterone therapy and VTE should be considered in assessing the benefit-risk ratio for men with hypogonadism.” 

That's not to say, however, that this treatment is absolutely risk free, he cautions. 

“We still need large-scale randomized placebo controlled trials, with long follow-up, to more fully and rigorously assess these risks.  But, currently, the medical evidence leads us to believe that a substantially increased risk of VTE among testosterone users is unlikely,” says Baillargeon. “In making their assessment, physicians must also consider the risks of not treating hypogonadism, which include increased risks of adiposity, metabolic syndrome, osteoporosis, decreased muscle mass, sexual dysfunction, and cardiovascular disease.

—Mark McGraw

Reference

Baillargeon J, et al. Risk of venousthromboembolism in men receiving testosterone therapy. Mayo Clin Proc. 2015.