According to study results published in JAMA International Medicine, testosterone therapy may be associated with increased risk for venous thromboembolism (VTE) among men with and without hypogonadism. Furthermore, the association appeared to be stronger among men younger than 65 years of age.
The study used a case-crossover design and analyzed data from the IBM MarketScan Commercial Claims and Encounter Database and the Medicare Supplemental Database between January 1, 2011, and December 31, 2017. National drug codes were used to identify billed testosterone therapy prescriptions for the patients within defined case and control periods.
Men, with or without hypogonadism, who had 12 months of continuous enrollment before a VTE event and without cancer at baseline were included. Each patient in the case period of the study was matched with himself in the control period. The case periods were defined as the presence of a testosterone prescription 6 months, 3 months, and 1 month before a first VTE event, while the control periods were 6 months, 3 months, and 1 month, respectively, within the 6 months preceding the case period.
Data for 39,622 men (mean age, 57.4 years) were used in the study. Evidence of hypogonadism using an array of diagnosis codes associated with the disorder was present for 3110 (7.8%) patients. In an overall model that made adjustments for age and included all study periods, testosterone therapy use was associated with a higher risk for VTE in men with hypogonadism (odds ratio [OR], 2.32; 95% CI, 1.97-2.74) and without hypogonadism (OR, 2.02; 95% CI, 1.47-2.77).
Among men without hypogonadism, those younger than 65 years had a higher risk for VTE (OR, 2.99; 95% CI, 1.91-4.68) during the 3-month case period compared with older men (OR, 1.68; 95% CI, 0.90-3.14); however, the interaction was not statistically significant (P =.14).
The researchers concluded that “future clinical trials of testosterone therapy, regardless of the indication, should capture VTE events as part of safety end points,” and “relative VTE risk may be exacerbated for men younger than 65 years using testosterone therapy with and without clinical indications.”
1. Walker RF, Zakai NA, MacLehose RF, et al. Association of testosterone therapy with risk of venous thromboembolism among men with and without hypogonadism [published online November 11, 2019]. JAMA Intern Med. doi:10.1001/jamainternmed.2019.5135