Abstract
In our sequential studies of 67 and 21 patients, testosterone therapy (TT) interacted with thrombophilia–hypofibrinolysis, leading to venous thromboembolism (VTE). Compared to 111 VTE controls not taking TT (VTE-no TT), the 67 and 21 cases were more likely (p < 0.05 for all) to have Factor V Leiden (FVL) heterogeneity (24% and 33% vs. 12%), the lupus anticoagulant (14% and 33% vs. 4%), and high lipoprotein(a) (33% vs. 13%, n = 21). After a first VTE and continuing TT, 11 thrombophilic cases had a second VTE despite adequate anticoagulation, 6 of whom, still anticoagulated, had a third VTE. The greatest density of thrombotic events was at three months after starting TT, with a rapid decline by 10 months. From <1 to 8 months after starting TT, 65% of VTE occurred, which may reflect TT-induced depletion of susceptible thrombophilic patients, leaving a winnowed residual group with fewer VTE events despite the continuation of TT. Before starting TT, we suggest screening for FVL, lipoprotein(a), and the lupus anticoagulant to identify patients at increased VTE risk, with an adverse risk-to-benefit ratio for TT. We suggest that TT should not be started in patients with known thrombophilia–hypofibrinolysis, and should not be continued after a first VTE. When TT is given to patients with thrombophilia–hypofibrinolysis, VTE may occur and then recur despite adequate anticoagulation.
Highlights
In June 2014, based on post-marketing surveillance reports including citation of some of our studies [1], the U.S Food and Drug Administration FDA [2] and Canada Health [3] added a warning regarding the risks of venous thromboembolism (VTE) to the label of all testosterone products.In January 2016, the FDA released a warning of possible increased cardiovascular risk associated with testosterone therapy (TT) [4]
We suggest that TT should not be started in patients with known thrombophilia–hypofibrinolysis, and should not be continued after a first VTE
When TT is given to patients with thrombophilia–hypofibrinolysis, VTE may occur and recur despite adequate anticoagulation
Summary
In June 2014, based on post-marketing surveillance reports including citation of some of our studies [1], the U.S Food and Drug Administration FDA [2] and Canada Health [3] added a warning regarding the risks of venous thromboembolism (VTE) to the label of all testosterone products. In January 2016, the FDA released a warning of possible increased cardiovascular risk (heart attack and stroke) associated with testosterone therapy (TT) [4]. The FDA has subsequently emphasized the importance of a prospective, blinded, placebo-controlled clinical trial to assess cardiovascular and thrombotic safety of TT [5]. Men in the intervention arm received 12 months of testosterone gel therapy to increase T levels to the mid-normal range for men aged 19–40. The TT group reported small increases in sexual activity, desire, and erectile function, and slightly improved
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