Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy

Objective: To examine the risk of venous thromboembolism (VTE) associated with exposure to testosterone therapy in middle-aged and older men.

Patients and methods: We conducted a case-control study of 30,572 men 40 years and older who were enrolled in one of the nation's largest commercial insurance programs between January 1, 2007, and December 31, 2012. Cases were defined as men who had a primary diagnosis of VTE and received an anticoagulant drug in the 60 days after their diagnoses. Cases were matched with 3 controls on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombotic condition. Conditional logistic regression analysis was used to calculate adjusted odds ratios (aORs) and 95% CIs for the risk of VTE associated with previous exposure to testosterone therapy.

Results: Exposure to testosterone therapy in the 15 days before the event/index date was not associated with an increased risk of VTE (aOR, 0.90; 95% CI, 0.73-1.12). None of the specific routes of administration examined were associated with an increased risk of VTE (topical [aOR, 0.80; 95% CI, 0.61-10.41], transdermal [aOR, 0.91; 95% CI, 0.38-2.16], and intramuscular [aOR, 1.15; 95% CI, 0.80-1.64]). These findings persisted using exposure windows that extended to 30 and 60 days before the event/index date.

Conclusion: Having filled a prescription for testosterone therapy was not associated with an increased risk of VTE in commercially insured middle-aged and older men. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.