What are the benefits and risks of testosterone therapy? Studies investigate

What are the benefits and risks of testosterone therapy? Studies investigate

"The results on diverse outcomes indicate the potential trade-offs between benefits and risks of testosterone treatment in older men", Evan Hadley, MD, director of National Institute on Aging's Division of Geriatrics and Clinical Gerontology, said in a press release from the NIH. The results add to evidence that challenges bold anti-aging claims of popular supplements. A larger and longer trial would be needed to determine if testosterone treatment reduces fracture risk.

The use of testosterone-replacement therapy has almost doubled in recent years, from 1.3 million patients in 2009 to 2.3 million in 2013, according to the U.S. Food and Drug Administration. At the start of the study, 493 of the participants had age-associated memory impairments (defined by both the men's own reports and by the results of memory tests).

Indeed, another trial published Tuesday, which was not part of the TTrials, showed a lower risk of cardiovascular events, including heart attack or stroke, in men who'd received testosterone, on average, for 3.4 years.

Results were published Tuesday in the journals JAMA and JAMA Internal Medicine. Sales of testosterone supplements for "Low T" skyrocketed, increasing tenfold in the United States between 2000 and 2011.

There is also a concern that testosterone treatment might make prostate cancer more likely, by fuelling tumour growth.

The testosterone gel used in a series of trials assessing health effects.

The cardiovascular health study was observational, using Cox proportional hazard models to study associations between testosterone treatment and various cardiovascular health outcomes.

The TTrials are now the largest trials to examine the efficacy of testosterone treatment in men 65 and older whose testosterone levels are low due seemingly to age alone.

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Further, testosterone treatment also increased haemoglobin concentrations, corrected the anaemia of men who had no other identifiable cause of anaemia and corrected the blood levels of men who had an identifiable cause, such as iron deficiency.

Anemia trial - Of all the men enrolled in the T Trial, 64 had anemia from known causes and 62 had unexplained anemia. The strengths of the study included the double-blind, placebo control design, 90% follow up, and biochemical confirmation of compliance. Low serum testosterone has been associated with lower hemoglobin levels and small studies have demonstrated improvement with testosterone replacement.

Dr. David Handelsman, from the University of Sydney and Concord Hospital, says that some problems are addressed by lifestyle measures.

Romashkan noted that the FDA is working with the pharmaceutical industry to conduct additional large-scale clinical trials looking at the heart health effects of testosterone. In the same manner, he calls for increased warning on testosterone packaging when it comes to cardiovascular risks. He said decisions about whether to use testosterone should take into account men's individual risks for conditions the hormone could affect.

Response: The Testosterone Trials were supported by a grant from the National Institute on Aging (NIA), National Institutes of Health (U01 AG030644). AbbVie (formerly Solvay and Abbott Laboratories) also provided funding, AndroGel, and placebo gel. In the past, studies haven't had clear results about how well replacement works and whether it's safe. As with all medications, the physician and patient need to balance the benefits and risks of treatment.

FMI: You'll find all the studies mentioned - and the editorial - in the February 21, 2017, issues of JAMA and JAMA Internal Medicine.

Susan S. Ellenberg, the study's lead biostatistician, clarified that TTrials are a single trial and randomization. The men in the study who were using the testosterone gel experienced a significantly greater buildup of plaque in their arteries compared to the men who were taking the placebo. There was some benefit for men with anemia - more on that study in a moment.

"I would say, ‚We have uncertainty about the health effects of testosterone and your risk of heart attacks".