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Long-term testosterone supplementation not associated with change in atherosclerosis progression
Older men with low or low-normal levels of testosterone who received testosterone supplementation for 3 years experienced similar changes to carotid intima-media thickness and coronary artery calcium compared with men who received placebo, according to new results of the TEAAM trial.
For the double blind, parallel-group trial, Shalender Bhasin, MBBS, director of Brigham and Women’s Hospital Research Program in Men’s Health: Aging and Metabolism, and colleagues randomly assigned 308 men aged 60 years or older (mean age, 67.6 years) to receive 7.5 g of 1% testosterone (n = 155) or placebo (n = 151) once daily for 3 years. All patients had low or low-normal testosterone levels at baseline (100 ng/dL to 400 ng/dL or free testosterone below 50 pg/mL). The target testosterone level was 500 ng/dL to 900 ng/dL. Forty-two percent of patients also had hypertension, 27% were obese, 15% had diabetes and 15% had CAD. Forty-three percent were receiving treatment with statins upon randomization.
The primary endpoints were common carotid artery intima media-thickness and coronary artery calcium. Sexual function and health-related quality of life were secondary endpoints.
Carotid intima-media thickness changed at a rate of 0.01 mm/year in the placebo group vs. 0.012 mm/year in the testosterone group. The mean difference was 0.002 mm/year after adjustment for age and trial site (P = .89).
Coronary artery calcium score also changed at a similar rate between groups (41.4 Agatston units/year with placebo vs. 31.4 Agatston units/year with testosterone). The adjusted mean difference was 10.8 Agatston units/year (P = .54). Bhasin and colleagues noted that there was no association between the changes in either endpoint and changes to testosterone levels among treated participants.
In other results, the researchers observed no difference between the treatment groups in sexual function or health-related quality of life.
Sensitivity analyses restricting analysis to patients who completed all 3 years of the intervention, stratified by coronary artery calcium at baseline or restricting analysis to patients without detectable coronary artery calcium at baseline, yielded similar results. However, the researchers noted that restricting analysis to statin nonusers indicated a significantly lower rate of change to coronary artery calcium among patients who received testosterone (mean difference, -30.1%; P = .04).
“The results of this trial suggest that testosterone should not be used indiscriminately by men,” Bhasin said in a press release. “We find that men with low and low-normal testosterone are unlikely to derive benefits in terms of sexual function or quality of life, two reasons why men may seek testosterone therapy. And although we find that testosterone did not affect the rate of hardening of the arteries, we need long-term data from large trials to determine testosterone’s effects on other major CV events.” – by Adam Taliercio
Disclosure: Bhasin reports financial relationships with Abbvie, Eli Lilly, Regeneron Pharmaceuticals and Sanofi, as well as equity interest in Function Promoting Therapies, LLC. Solvay Pharmaceuticals Inc. and Abbvie Pharmaceuticals Inc. supported the study and provided the testosterone and placebo used. See the study for a list of other authors’ relevant financial disclosures.