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Testosterone therapy increases short-term venous thromboembolism risk in men
Testosterone therapy is associated with an increased short-term risk for venous thromboembolism in all men, suggesting that physicians should use caution when prescribing the therapy, according to findings published in JAMA Internal Medicine.
“In 2014, the [FDA] released a warning about testosterone therapy and the potential risk of heart attack and stroke; since then, testosterone therapy prescriptions have decreased and eventually plateaued,” Rob F. Walker, MPH, of the division of epidemiology and community health in the School of Public Health at the University of Minnesota, and colleagues wrote.
“Evidence suggests that testosterone therapy is still being prescribed to men without hypogonadism,” they continued.
Walker and colleagues conducted a case-crossover study using health care claims from the IBM MarketScan Commercial Claims and Encounter Database and the Medicare Supplement Database. The analysis included 39,622 men between the ages of 18 and 99 years — 7.8% of whom were diagnosed with hypogonadism — with a minimum of one inpatient or two outpatient claims for venous thromboembolism in 6 months.
Men who did not have 12 months of follow-up data available or who had cancer at baseline were excluded from the study, researchers said.
Walker and colleagues evaluated testosterone therapy exposure at 1, 3 and 6 months before a venous thromboembolism event to assess the time frame in which these events could be triggered by testosterone therapy.
After adjusting for age, researchers identified an increased risk for venous thromboembolism with testosterone therapy use both in men with (OR = 2.32; 95% CI, 1.97-2.74) or without (OR = 2.02; 95% CI, 1.47-2.77) hypogonadism.
The risk for venous thromboembolism was highest in men without hypogonadism aged younger than 65 years at 3 months (OR = 2.99; 95% CI, 1.91-4.68). Older men had a lower risk that was not statistically significant (OR = 1.68; 95% CI, 0.9-3.1).
The risk for venous thromboembolism did not differ between transdermal and intramuscular testosterone therapy. The researchers did not mention oral testosterone therapy.
“These data combined with prior data suggest that future clinical trials of testosterone therapy, regardless of the indication, should capture venous thromboembolism events as part of safety end points,” Walker and colleagues wrote.
“Men experiencing common symptoms that result from natural aging have considered testosterone therapy as a treatment; however, men without hypogonadism should assess cardiovascular disease risk with their physicians before prescription to minimize adverse cardiovascular outcomes,” they continued. – by Erin Michael
Disclosures: Walker reported receiving grants from the National Heart, Lung, and Blood Institute, part of the NIH, during the conduct of the study. Please see study for all other authors’ relevant financial disclosures.
Editor’s note: This story was updated to show that the researchers found no difference in the risk between numerous formulations of transdermal and intramuscular testosterone therapy.