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    Test article 2-22-16

    In the largest randomized, controlled trial to investigate the benefits of testosterone therapy in men 65 years of age and older, researchers report raising testosterone concentrations offers moderate benefits in sexual function and some benefit on mood and depressive symptoms.

    The New England Journal of Medicine published results of three of seven of the Testosterone Trials (TTrials) (2016; 374:611-24). The TTrials are a coordinated group of seven trials testing the effect of a testosterone gel compared with a placebo gel. The NEJM study includes the results of the three primary trials—sexual function, physical function, and vitality.

    The authors, led by Peter J. Snyder, MD, of University of Pennsylvania Perelman School of Medicine, Philadelphia, studied 790 men 65 years of age and older. Subjects, who had serum testosterone concentrations of less than 275 ng/dL and symptoms suggesting hypoandrogenism, received either testosterone gel or placebo gel for 1 year.

    “The results of the TTrials show for the first time that testosterone treatment of older men who have unequivocally low testosterone levels does have some benefit. However, decisions about testosterone treatment for these men also will depend on the results of the other four trials—cognitive function, bone, cardiovascular, and anemia—and the risks of testosterone treatment,” Dr. Snyder said in a Penn press release.

    Urology Times Editorial Council member Arthur L. Burnett, II, MD, MBA, also praised the study.

    “This is a solid study with respect to its well-defined study population, high-caliber study design, rigor, and execution, and excellent choice of endpoints. It affirms the understanding that testosterone therapy (in the form of topical therapy administered to eugonadal therapeutic levels) significantly benefits sexual function (sexual activity, sexual desire, and erectile function) and modestly improves physical function and depressive symptoms. The findings also show that this therapy affords safety with regard to cardiovascular risk, prostate health risk and urinary symptoms,” said Dr. Burnett, of Johns Hopkins University, Baltimore.

    Also see: Studies demonstrate testosterone’s CV safety, benefits

    Dr. Burnett included a caveat with his comments, however.

    “These positive conclusions must be tempered, however, by the constraints of this study that enrolled fairly healthy older but not elderly men and the relatively short-term use of therapy and (12 months) and follow-up (12 months),” Dr. Burnett added.

    Ranjith Ramasamy, MD, of the University of Miami, told Urology Times these are important findings, statistically and clinically.

    “The results are significant because the results of the study are in contrast to the results of the TEAAM trial (JAMA 2015; 314:570-81) [and] because this is the first randomized trial that showed beneficial effects in elderly men who received testosterone therapy,” Dr. Ramasamy said.

    The results observed in this new study are what prospective studies have demonstrated previously (including Eur Urol 2015; 67:167-7), according to Dr. Ramasamy.

    Much of the controversy over testosterone replacement therapy for the last 3 years has been anchored by cardiovascular concerns based primarily on intense media coverage of two retrospective studies (JAMA 2013; 310:1829-36PLOS One 2014; 9:e85805). The JAMA study initially reported that absolute rate of cardiovascular events was higher among testosterone-deficient men treated with testosterone compared with untreated men, according to Dr. Morgentaler.

    “This was an error, however, as the correct absolute rate of events was lower by half in the T-treated group compared with untreated men (10.1% vs. 21.2%, respectively). Twenty-nine medical societies petitioned JAMA to retract the article when it was subsequently revealed that nearly 10% of the all-male study population was comprised of women,” Dr. Morgentaler said. “Since publication of those studies, there have been more than a dozen studies demonstrating either no negative CV consequences of T therapy, or reduced CV events.

    Have you read - ED, diabetes, and CV risk: Update on treatment, risk reduction

    “In the current study, there were exactly the same number of major cardiovascular events (seven) in the treatment and placebo arms. Interestingly, in the subsequent year of follow-up, there were only two events in the testosterone arm and nine in the placebo arm. Clearly, there is no hint of increased CV events with testosterone in this large prospective study,” Dr. Morgentaler added.

     

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