For men with age-related decline in testosterone levels, there is significant controversy over the risks and benefits of testosterone supplementation. Despite a paucity of data, testosterone sales have increased markedly in the past decade. The Testosterone’s Effects on Atherosclerosis Progression in Aging Men (TEAAM) Trial evaluated the impact of increasing testosterone concentrations on progression of atherosclerosis as determined by common carotid artery intima-media thickness and coronary artery calcium. In addition, the investigators evaluated the effect of testosterone therapy on patient reported sexual function and health-related quality of life (SF-36). This randomized, double-blind, placebo-controlled trial enrolled 308 men >60 years old with low or low-normal testosterone (100-400ng/dL) levels and compared testosterone supplementation to levels between 500-900 ng/dL to placebo. For the measures of atherosclerosis progression, there was no difference between the treatment and placebo group. Additionally, measures of sexual function and health-related quality of life did not differ between the treatment groups.
Conclusions: Although this small trial found no evidence of atherosclerosis progression in relation to testosterone therapy, this secondary outcome should not be used to support the safety of testosterone therapy. Additionally, the lack of patient symptom benefit with testosterone therapy in this trial raises concerns about whether testosterone replacement provides benefit in this population. Large scale randomized trials are needed to help determine the full spectrum of risk and benefit for this widely used therapy.
Summarized by Lauren E. Thompson and Steven M. Bradley
Basaria S, Harman SM, Travison TG, Hodis H, Tsitouras P, Budoff M, Pencina KM, Vita J, Dzekov C, Mazer NA, Coviello AD, Knapp PE, Hally K, Pinjic E, Yan M, Storer TW, Bhasin S.Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone LevelsA Randomized Clinical Trial. JAMA. 2015;314(6):570-581.