The association between testosterone replacement therapy (TRT) and thrombotic risk in elderly men remains controversial. While the FDA has mandated that all approved testosterone products include warnings about a possible increase in cardiovascular, stroke, and venous blood clot risk, at least one study presented at the AUA annual meeting in New Orleans found no link between TRT and cardiovascular events.
New Orleans-The association between testosterone replacement therapy (TRT) and thrombotic risk in elderly men remains controversial. While the FDA has mandated that all approved testosterone products include warnings about a possible increase in cardiovascular, stroke, and venous blood clot risk, at least one study presented at the AUA annual meeting in New Orleans found no link between TRT and cardiovascular events.
Researchers from Baylor College of Medicine in Houston examined the association between testosterone and myocardial infarction, stroke, and pulmonary embolism in men over the age of 65 years with confirmed hypogonadism. TRT was not associated with an increased risk of thrombotic events, including myocardial infarction (MI), transient ischemic attack (TIA), cerebrovascular accident (CVA or stroke), and pulmonary embolism (PE).
Study authors conducted a retrospective records review of more than 200 men with low testosterone (2 am T <300 ng/ml associated with symptoms) and compared those who were treated with TRT to those who were not. Of the participants, 153 men were on testosterone therapy (53 each receiving injections or pellets and 47 receiving gel), and 64 men did not receive TRT.
Median follow-up in men on TRT and those not receiving treatment was 3.8 and 3.5 years, respectively.
None of the men who received TRT died, whereas there were five deaths among men who did not receive TRT (p=.007). Four thrombotic events (one MI, two CVA/TIA, one PE) occurred in the TRT group compared to one event (CVA/TIA) in the group not receiving treatment (p=.8).
“We found that the number of deaths was higher in the men that were not treated with testosterone therapy,” first author Ranjith Ramasamy, MD, a former Baylor urology resident, told Urology Times. “No statistically significant difference in the prevalence of MI, TIA/CVA, or PE was found between the groups.”
The current study has a number of strengths that are lacking in other investigations of testosterone and cardiovascular risk, said Dr. Ramasamy, who is currently assistant professor of urology at the University of Miami.
“I think this study addresses some of the limitations that are present in some of the large epidemiologic studies, such as the presence of a control group and a very long follow-up of about 3 years,” he said. “We had testosterone levels drawn on all the patients, we followed them personally, and we verified the deaths with the national death index. We also called all these men in study to make sure that these thrombotic events were accurate.”
Dr. Ramasamy also pointed out weaknesses in the study, including its small sample size and retrospective design.
“I think that this study gives us very good information to counsel patients that testosterone therapy can be safe in this elderly population-if given right and if the patients are followed up appropriately with the appropriate medications,” he said.