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Testosterone therapy elevated adverse CV outcome risk in men
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The use of testosterone therapy was associated with greater risk for all-cause mortality, MI and ischemic stroke in men who underwent coronary angiography and had a low serum testosterone level, according to findings in a new report.
Researchers studying men in the Veterans Affairs health care system found that the effect was similar regardless of the presence of CAD.
The retrospective national cohort study included men with testosterone levels <300 ng/dL who underwent coronary angiography in the VA system between 2005 and 2011 (n=8,709). Mean follow-up was 27.5 months.
The primary endpoint was a composite of time to all-cause mortality or hospitalization for MI or ischemic stroke. The analysis compared men who started testosterone therapy after coronary angiography (n=1,223) with those who did not (n=7,486).
Overall, 1,710 outcome events were reported: 748 deaths, 443 MIs and 519 strokes. Among the 1,123 men receiving testosterone therapy, 67 deaths, 23 MIs and 33 strokes occurred. Among the 7,486 men not receiving testosterone therapy, 681 deaths, 420 MIs and 486 strokes occurred.
The researchers found an absolute risk difference of 5.8% at 3 years after angiography between those who received testosterone therapy and those who did not (therapy group, 25.7% event rate; non-therapy group, 19.9%).
After adjusting for the presence of CAD, testosterone therapy as a time-varying covariate was linked to increased risk for the primary endpoint (HR=1.29; 95% CI, 1.04-1.58). There was no difference in the effect size of testosterone therapy between those who did and did not have CAD (P for interaction=.41).
“These findings raise concerns about the potential safety of testosterone therapy,” Rebecca Vigen, MD, MSCS, of the University of Texas at Southwestern Medical Center in Dallas, and colleagues wrote. “The use of testosterone therapy was significantly associated with adverse outcomes despite the lower prevalence of baseline comorbidities in the testosterone therapy group.”
BP, LDL and secondary prevention medications were similar between the groups, so differences in risk factor control and secondary prevention medication use could not explain the results, according to the researchers.
Anne R. Cappola
In a related editorial, Anne R. Cappola, MD, ScM, of the Perelman School of Medicine at University of Pennsylvania, said it is unclear whether the results from the study are generalizable to broader population of men taking testosterone.
However, she wrote, “in light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary. There is mounting evidence of a signal of cardiovascular risk, to which the study by Vigen et al contributes.”
For more information:
Cappola AR. JAMA. 2013;310:1805-1806.
Vigen R. JAMA. 2013;310:1829-1836.
Disclosure: The researchers report no relevant financial disclosures. Cappola reports financial ties with Abbott Laboratories and BioSante Pharmaceuticals.
Perspective
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Ravi Dave, MD
This study adds a lot to the knowledge base. There have been newer and newer ways of administering testosterone into patients. Patients are requesting these tests to be done on a routine basis. That’s something that has changed in the last 5 years. There are a lot of advertisements in social media, on television and in medical journals about different ways to administer testosterone and the potential benefits. It has been very popular to get checked and to get treated for testosterone deficiency. It’s something men are looking at in terms of addressing symptoms that they’re having with advancing age: fatigue, lack of exercise, energy level, etc.
I don’t think these findings came from out of the blue. No kind of hormonal replacement, whether in the form of an anabolic steroid or hormone replacement therapy in women, has come out as a positive unless you are seriously deficient in a hormone that’s required to have normal body function. For any bodybuilding or muscle-building activity, hormonal therapy has never come out as a positive. There has always been a concern that this could increase your risk for heart disease.
The findings have potential to change clinical practice. I just had a patient ask me about testosterone. He’s had a heart attack, and I told him I would not recommend testosterone therapy for him. Prior to this study, I would have said OK. I mentioned to him that the reason why I would ask him not to take this supplement is that I really don’t know if there are any untoward effects of testosterone supplementation in him because of his history of heart disease. Since this was not a randomized controlled trial, in the future, if more studies show that the risk is minimal or nonexistent, I would feel more comfortable recommending testosterone therapy for patients who have heart disease or are at risk for heart disease. I would definitely recommend all patients to have their cardiac status checked.
I think this issue can also tie into the new ACC/AHA guideline that provides a calculator to assess your 10-year risk for CVD. Though it’s not recommended, if a patient came to me and said ‘I don’t have heart disease, I have high cholesterol, I want to consider testosterone,’ I would calculate their 10-year risk. If it’s very high, I would say it’s not the right thing. If it’s very low, I would still caution them about the association with mortality and heart attack and stroke.
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