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Safety of testosterone questioned in veterans with diabetes, CAD
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LOS ANGELES — The use of testosterone replacement therapy in veterans with CAD who underwent coronary angiography is associated with an increased risk for MI and death, when compared with no testosterone therapy use, according to data presented here.
The association between testosterone replacement therapy and mortality and MI appeared stronger among patients with no VAD than those with CAD.
Rebecca Vigen, MD, MPA, from the cardiology section of VA Eastern Colorado Health Care System in Denver, Colorado, and colleagues used the VA CART-CL registry to find veterans who underwent coronary angiography between 2005 and 2011 and had total testosterone levels ≤300 ng/dL following their procedure.
The researchers studied 8,849 veterans, 15% of whom were administered testosterone replacement therapy an average of 418 days following coronary angiography.
Vigen reported a significant association between the use of testosterone replacement therapy and all-cause mortality and acute MI (HR=1.45; 95% CI, 1.14-1.86). This relationship appeared stronger among patients who did not have significant CAD on angiography (HR=3.17; 95% CI, 1.62-6.20).
“A significant portion of men undergoing angiography, who had levels checked, had a total testosterone level of <300 mg/dL. Testosterone replacement therapy use was associated with all-cause mortality and acute MI in veterans. This relationship was stronger among patients with no CAD vs. those with CAD on angiography,” Vigen said.
Prescriptions for testosterone replacement therapy increased from about 700,000 in 2000 to more than 2.5 million in 2008, according to Vigen.
“These findings may have potential implications for targeting testosterone use among selected patient populations,” the researchers said. – by Samantha Costa
For more information:
Vigen R. Abstract #19261. Presented at: the American Heart Association Scientific Sessions; Nov. 3-7, 2012; Los Angeles.
Disclosure: Vigen reports supported from a Cardiovascular Outcomes Research Fellowship through a Department of Veterans Affairs Graduate Medical Education Enhancement Grant.
Perspective
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Robert W. Yeh, MD, MSc
This was a study that showed where the real value of comparative effectiveness research happens: in a setting where a randomized clinical trial has not sufficiently answered the question and is maybe no longer feasible. But it also raises important questions about when we feel that comparative effectiveness research has answered the question adequately, without residual bias or confounding.
In the audience, there were several questions about the methodology of these types of studies, and audience members were appropriately skeptical. Nonrandomized studies of comparative effectiveness are often received in this manner. However, since there are questions about the methodology, in this case, it is unlikely that we will ever have a confirmatory clinical trial, we are in a challenging position to determine whether we are to accept these findings and alter our clinical practice based on them. This highlights the impasse that we are often in, and one of the challenges of our field is to move past these questions and feel confident in our methodological approach. From a clinical standpoint, this study raises concerns [as to] whether we should be using testosterone replacement therapy. It has been shown to increase muscle mass and improve some quality of life, but there is a trade-off with potential increase for CV risk. That sort of trade-off needs to be discussed between the patient and the physician about whether or not treatment is worthwhile.
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