Television, print, and online ads continue to tout testosterone supplements as a panacea for “low T” in men—those with documented low testosterone levels. The ads seem to be working, as rates of testosterone therapy prescription in the United States have increased fivefold markedly from 2000 to 2011, reaching 5.3 million prescriptions and a market of $1.6 billion in 2011. But is this “T party” safe for all men?
A study published recently in the Journal of the American Medical Association suggests that among a group of men who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of death, heart attack, or ischemic stroke.
Professional society guidelines recommend testosterone therapy for patients with symptomatic testosterone deficiency. In addition to improving sexual function and bone mineral density and increasing free-fat mass and strength, treatment with testosterone can improve lipid profiles and insulin resistance and increase the time to ST depression during stress testing. However, a recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety.
Researchers from the University of Texas at Southwestern Medical Center evaluated the association between the use of testosterone therapy and all-cause mortality, myocardial infarction (MI), and stroke among male veterans and whether this association was modified by underlying coronary artery disease (CAD). The study included 8709 men with low testosterone levels (
The proportion of patients experiencing events 3 years after coronary angiography was 19.9% in the no-testosterone therapy group and 25.7% in the testosterone therapy group (absolute risk difference of 5.8%), even after accounting for other factors that could explain the differences. The increased risk of adverse outcomes associated with testosterone therapy use was not related to differences in risk factor control or rates of secondary prevention medication use because patients in both groups had similar blood pressure, low-density lipoprotein levels, and use of secondary prevention medications.
THE BOTTOM LINE
Although the media would have men believe otherwise, “low T” is not an inevitable consequence of aging. Unlike women, who lose most of the sex hormones following menopause, testosterone levels in men normally fall by only 1% to 2% per year after age 40. In fact, one of the British Medical Journal publications estimates that only 20% of men in their 60s and 50% of men in their 80s have documented low testosterone levels. Testosterone supplements are not approved by the Food and Drug Administration (FDA) to improve strength, physical appearance, or prevent aging. And this is not the first study to have called out a relationship between testosterone replacement therapy (TRT) and poor cardiovascular outcomes.
What should you do when a patient demands TRT? In light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary. The authors of this Journal of the American Medical Association study call for caution when prescribing TRT because “These findings raise concerns about the potential safety of testosterone therapy.” They also call for future studies—including randomized controlled trials—to properly characterize the potential risks of testosterone therapy in men with comorbidities.