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Trials Highlight Benefits, Risks of Testosterone Treatment

While trials show it boosts bone density and lowers anemia risk, heart risks also seen

TUESDAY, Feb. 21, 2017 (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 Feb. 21 in either the Journal of the American Medical Association or JAMA Internal Medicine.

The Testosterone Trials are a set of seven 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 four trials were as follows: For the anemia trial, 54 percent of men with unexplained anemia and 52 percent 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 percent, respectively, of those in a placebo group. For the bone trial, after one 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, 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, 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 study showed a 33 percent reduced risk of adverse cardiovascular events with an average follow-up of about three 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.

Abstract/Full Text – Anemia Trial
Abstract/Full Text – Bone Trial
Abstract/Full Text – Cardiovascular Trial
Abstract/Full Text – Cognition Trial
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Abstract/Full Text – Cardiovascular Study
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