JAMA: Testosterone Trial Results Highlight Benefits and Risk of Testosterone Treatment

Studies published in JAMA and JAMA Internal Medicine highlight the benefits and risks of treating men for low testosterone.
Studies published in JAMA and JAMA Internal Medicine highlight the benefits and risks of treating men for low testosterone.

HealthDay News — Testosterone treatment can boost bone density and reduce anemia in older men with low levels of the hormone, but it might also increase the risk of future adverse cardiovascular events, a new set of trials suggests. The research was published in either the Journal of the American Medical Association or JAMA Internal Medicine.

The Testosterone Trials are a set of 7 overlapping federally funded year-long clinical trials conducted at 12 sites across the United States. The trials involved 790 men aged 65 and older with low levels of testosterone caused by aging, as well as symptoms that could be related to low testosterone such as sexual problems, fatigue, muscle weakness, or impaired memory and cognition.

The findings of the final 4 trials were as follows: For the anemia trial,1 54% of men with unexplained anemia and 52% with anemia from known causes had clinically significant increases in their red blood cell levels after a year of testosterone therapy, compared with 15% and 19%, respectively, of those in a placebo group. For the bone trial,2 after 1 year, participants experienced significantly increased bone mineral density and estimated bone strength. The results were greater in the spine than the hip. For the cardiovascular trial,3 the researchers found that the volume of arterial plaque increased significantly more in the testosterone-treated group compared to the untreated control group. For the cognition trial,4,5 after a year of treatment, there was no significant change in verbal memory, visual memory, or problem-solving.

JAMA Internal Medicine also published a study conducted outside the Testosterone Trials, which showed a short-term reduction in heart attacks and strokes among men receiving testosterone. That study6,7 showed a 33% reduced risk of adverse cardiovascular events with an average follow-up of about 3 years, compared with non-testosterone users. However, it was not a clinical trial; researchers used the medical records of 8,808 men in California to draw their conclusions.

AbbVie provided funding, AndroGel, and placebo gel for the Testosterone Trials; several authors disclosed financial ties to the pharmaceutical industry.

References

  1. Roy CN, Snyder PJ, Stephens-Shields AJ, et al. Association of testosterone levels with anemia in older men [published online February 21, 2017]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.9540
  2. Snyder PJ, Kopperdahl DL, Stephens-Shields AJ, et al. Effect of testosterone treatment on volumetric bone density and strength in older men with low testosterone [published online February 21, 2017]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.9539
  3. Budoff MJ, Ellenberg SS, Lewis CE, et al. Testosterone treatment and coronary artery plaque volume in older men with low testosterone. JAMA. 2017;317(7):708-716. doi: 10.1001/jama.2016.21043
  4. Resnick SM, Matsumoto AM, Stephens-Shields AJ, et al. Testosterone treatment and cognitive function in older men with low testosterone and age-associated memory impairment. JAMA. 2017;317(7):717-727. doi: 10.1001/jama.2016.21044
  5. Handelsman DJ. Testosterone and male aging. JAMA. 20147;317(7):699-701. doi: 10.1001/jama.2017.0129
  6. Cheethman TC, An JJ, Jacobsen SJ, et al. Association of testosterone replacement with cardiovascular outcomes among men with androgen deficiency [published online February 21, 2017]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.9546
  7. Orwoll E. Further elucidation of the potential benefits of testosterone therapy in older men [published online February 21, 2017]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.9576
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