Risk for venous thrombotic events no higher in men with hypogonadism on testosterone therapy

SAN DIEGO — Men with hypogonadism do not appear to have any increased risk for venous thrombotic events with exogenous testosterone replacement therapy, according to research presented at The Endocrine Society annual meeting.

“After carefully designing and evaluating real-world evidence data, we failed to find a positive relationship between testosterone replacement therapy and idiopathic venous thrombotic events,” Hu Li, MBBS, PhD, of Eli Lilly and Company, Indianapolis, Indiana, told Endocrine Today. “Although the study is observational in nature with its own limitation, it provides valuable information to physicians and patients in addition to spontaneously reported cases.”

In a retrospective cohort and nested-case-control analyses, Li and colleagues investigated the relationships between testosterone replacement therapy (TRT) and venous thrombotic events (VTE) among adult men with hypogonadism aged at least 18 years.

The investigators searched Truven Databases to obtain data on men with a hypogonadal condition, defined as being treated with an approved TRT product or untreated but having a hypogonadal diagnosis per International Classification of Diseases criteria. Patients had been enrolled in a health care plan for at least 12 months and had no VTE diagnosis at baseline.

After propensity score matching in a 1:1 ratio to ensure comparability, 102,650 patients treated with TRT and 102,650 untreated patients with idiopathic VTE were included.

Treated and untreated patients were then matched in a 1:4 ratio based on age and calendar year.

Index date among treated men (n = 2,785) was defined as the first TRT prescription and among untreated men (n = 11,119) was assigned at random according to the distribution for those treated. Incident VTE, and primarily idiopathic VTE, was the main outcome sought. The researchers assessed exposure as any TRT use and different administration methods.

Cox regression and conditional logistic regression models were used in the cohort and nested analyses to assess, respectively, HRs and ORs for relationships between TRT and VTE. Sensitivity analyses were performed with varied TRT exposure and VTE parameters.

In the retrospective cohort analysis, the HR for patients treated with any TRT was 1.08 (95% CI, 0.91-1.27), with topical/gel TRT was 1.07 (95% CI, 0.88-1.29) and with injectable TRT was 1.32 (95% CI, 0.89-1.96). The results were not significant when men were stratified by age.

Nested analyses of treated and untreated groups revealed similar, but not significant findings. The likelihood of having VTE with current TRT use was slightly higher than past TRT use (OR = 1.02; 95% CI, 0.92-1.13 vs. OR = 0.92; 95% CI, 0.82-1.03). When patients were stratified by age and TRT administration, results were similar but nonsignificant.

“Future studies are warranted to confirm the study findings,” Li said. “Regardless of this study finding, Lilly has updated the Axiron U.S. product label and the Medication Guide to reflect the additional language requested by FDA related to thromboembolic risk.” – by Allegra Tiver

Reference:

Li H. Abstract OR34-2. Presented at: The Endocrine Society Annual Meeting; March 5-8, 2015, San Diego.

Disclosure: Li reports being an employee at Eli Lilly & Company.