[ music ] >> the jama network. [ silence ] >> i'm shalender bhasin, professor ofmedicine at harvard medical school. i'm director of the center of clinicalinvestigation and director of research program
dexamethasone, in men's health aging andmetabolism at the brigham and women's hospital in boston, massachusetts. there's growing concern thattestosterone sales have been growing at 20 to 25% annual rate over the past 10 years.
there's also concern whether testosteronetherapy increases the risk of heart disease. this study was designed to determine whethertestosterone therapy increases the progression of atherosclerosis in men who havelow or low normal testosterone levels. the testosterone in atherosclerosis progressiontrial was a randomized placebo controlled parallel group trial in which older communitydwelling men who were otherwise healthy and who had testosterone levels in thelow or low normal range were randomized to receive either placebo or testosterone gel. three hundred and 8 men participatedin this randomized trial. the duration of the intervention was 3 years.
during this period, testosterone levels weremeasured to maintain the testosterone levels in men who were assigned to the testosteronegroup into the middle of the normal male range. the primary outcome of the trialwas atherosclerosis progression. atherosclerosis progression in thetrial was measured in 1 of 2 ways. first, we looked at [inaudible] medial thickness in the common carotid artery asa measure of atherosclerosis. and second we looked at coronary artery calciumusing multi detector computerized tomography to measure coronary artery calcium. another measure of atherosclerosis.
the main finding of the trial was thattestosterone administration over a period of 3 years as compared to placebo did notaffect the rate of atherosclerosis progression. the results obtained from measurementof coronary artery calcium as well as from [inaudible] medial thickness inthe common carotid artery were consistent in demonstrating no affects of testosteroneon the progression of atherosclerosis. the secondary outcomes of the trial were sexualfunction and health related quality of life. testosterone also did not improve either thesexual function or health related quality of life in men who had low normal orslightly low testosterone concentrations. because the trial was powered primarilyfor atherosclerosis progression,
these findings should not be extrapolatedto imply that testosterone is safe with respect to cardiovascular events. also, these findings should not beextrapolated to [inaudible] adult men who have low testosterone levels because ofknown diseases of the testes, the pituitary or the hypothalamus, in whomtestosterone therapy has been shown
to improve sexual functionand many other outcomes. well, we need much larger trials that are adequately [inaudible] towardcardiovascular disease event rates to address the cardiovascular safety issue.