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>> The JAMA Network.
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>> I'm Shalender Bhasin, Professor of Medicine at Harvard Medical School.
I'm Director of the Center of Clinical Investigation and Director of Research Program
in Men's Health aging and metabolism at the Brigham
and Women's Hospital in Boston, Massachusetts.
There's growing concern that testosterone sales have been growing at 20
to 25% annual rate over the past 10 years.
There's also concern whether testosterone therapy increases the risk of heart disease.
This study was designed to determine whether testosterone therapy increases the progression
of atherosclerosis in men who have low or low normal testosterone levels.
The testosterone in atherosclerosis progression trial was a randomized placebo controlled
parallel group trial in which older community dwelling men who were otherwise healthy
and who had testosterone levels in the low or low normal range were randomized
to receive either placebo or testosterone gel.
Three hundred and 8 men participated in this randomized trial.
The duration of the intervention was 3 years.
During this period, testosterone levels were measured to maintain the testosterone levels
in men who were assigned to the testosterone group into the middle of the normal male range.
The primary outcome of the trial was atherosclerosis progression.
Atherosclerosis progression in the trial was measured in 1 of 2 ways.
First, we looked at [inaudible] medial thickness
in the common carotid artery as a measure of atherosclerosis.
And second we looked at coronary artery calcium using multi detector computerized tomography
to measure coronary artery calcium.
Another measure of atherosclerosis.
The main finding of the trial was that testosterone administration over a period
of 3 years as compared to placebo did not affect the rate of atherosclerosis progression.
The results obtained from measurement of coronary artery calcium as well
as from [inaudible] medial thickness in the common carotid artery were consistent
in demonstrating no affects of testosterone on the progression of atherosclerosis.
The secondary outcomes of the trial were sexual function and health related quality of life.
Testosterone also did not improve either the sexual function or health related quality
of life in men who had low normal or slightly low testosterone concentrations.
Because the trial was powered primarily for atherosclerosis progression,
these findings should not be extrapolated to imply that testosterone is safe
with respect to cardiovascular events.
Also, these findings should not be extrapolated to [inaudible] adult men
who have low testosterone levels because of known diseases of the testes, the pituitary
or the hypothalamus, in whom testosterone therapy has been shown
to improve sexual function and many other outcomes.
Well, we need much larger trials
that are adequately [inaudible] toward cardiovascular disease event rates
to address the cardiovascular safety issue.
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