Study: No increase in CV risk with testosterone

Testosterone replacement therapy reduced men’s overall risks for death, nonfatal myocardial infarction, and stroke, as well as for death alone in a study presented at the American Heart Association Scientific Sessions in Chicago.

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Researchers from the Intermountain Medical Center Heart Institute in Murray, UT studied the health records of nearly 5,700 men, ages 53 to 71 years, who had been diagnosed with low testosterone levels at the Intermountain Healthcare system. They looked at the men’s subsequent testosterone levels with treatment at 1 and 3 years. Primary outcomes included a composite of death, nonfatal heart attack, and stroke, and death alone. They compared groups of persistent low testosterone, defined as less than 212 ng/dL, normal (between 212 and 742 ng/dL), and high >742 ng/dL.

They found:

• Overall 3-year rates for the composite outcome were 8.6% and for death alone 6.4%.

• At 3 years, those supplemented to normal/high testosterone levels had a 45% reduced risk of the combination of death, nonfatal heart attack, and stroke and 57% reduced risk of death alone compared to persistent low testosterone subjects. However, because of a signal for increased MI and stroke, supplementation to high testosterone levels should be avoided, the study’s lead author, Jeffrey Anderson, MD, told Urology Times in an email. “Large, randomized trials are now needed to clarify and confirm these findings,” he wrote.

• Results were similar at 1 year.

The findings come after an FDA advisory committee voted in September to restrict indications for testosterone replacement therapy and required additional clinical trials to test the safety of the drugs, decisions that drew mixed reactions from urologists.

The advisory committee’s conclusions reinforce the need to conduct a thorough diagnosis based on serum testosterone levels and clinical symptoms and to follow patients in whom treatment is indicated, according to John J. Mulcahy, MD, PhD, a member of the Urology Times Editorial Council. Abraham Morgentaler, MD, a urologist who made an oral presentation to the committee during a public hearing, called the vote “a step backwards for our patients and for science.”

The FDA’s original Drug Safety Communication about the cardiovascular safety of testosterone therapy was posted in January, and was prompted by two published studies that evaluated the potential risk of stroke, heart attack, and death in men taking testosterone products.

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