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Testosterone therapy risks need more evaluations

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The Endocrine Society calls for large-scale studies to evaluate testosterone therapy risks, says a new study. Aging men weighing treatment should be warned about cardiovascular events. According to a statement issued today by the Endocrine Society, the risks and benefits of testosterone therapy for older men with declining levels of the hormone need to be fully evaluated, says a February 7, 2014 news release, "Endocrine Society calls for large-scale studies to evaluate testosterone therapy risks." The Society calls for the development of more large-scale randomized controlled trials to determine the true risks and benefits of testosterone therapy in older men.

One of the problems is the low immunity in men with high testosterone levels. You can check out the research, "Study: flu vaccine less effective for men with high testosterone levels." Testosterone supplementation needs more evaluations.

The Society's full statement, a PDF file article can be accessed at the Endocrine.org Advocacy site. https://www.endocrine.org/~/media/endosociety/Files/Advocacy and Outreach/Position Statements/Other Statements/The Risk of Cardiovascular Events in Men Receiving Testosterone Therapy.pdf. Also see the NBC article, "Testosterone may make men likely to get the flu, study finds."

The statement comes in response to recent studies that have raised concerns about the safety of testosterone therapy in older men with a history of heart disease. Two retrospective analyses and one randomized trial supported by the Veterans Health Care System, and the National Institutes of Health found a higher rate of cardiovascular events in men who received testosterone and had preexisting heart problems.

The U.S. Food and Drug Administration has announced it plans to evaluate the safety of testosterone therapy. Testosterone is approved for the treatment of hypogonadism due to known diseases of the testes, pituitary and hypothalamus.

Although the use of testosterone therapy is increasing, the treatment has not been approved for the treatment of age-related symptoms or the age-related decline of testosterone levels

Important safety data are expected from the NIA's ongoing randomized trial examining testosterone in about 800 older men with unequivocally low testosterone levels and accompanying symptoms, including sexual and physical dysfunction. The trial's structure and careful monitoring of cardiovascular events will help provide important safety information.

In the statement, the Society recommends that middle-aged and older men who are considering testosterone supplementation for age-related declines should be informed of the potential cardiovascular risks

The Society also believes that it may be prudent not to administer testosterone therapy to men who have had a cardiovascular event (such as myocardial infarction, stroke or acute coronary syndrome) in the preceding six months. In cases where men are being treated for hypogonadism as a result of known diseases of the testes, pituitary and hypothalamus. However, patients should consult their health care providers before making any changes to their medication regimen.

The Society believes testosterone is generally safe and beneficial when used to treat young, hypogonadal men with these conditions. The Society's article, "Clinical Practice Guideline on testosterone therapy" in this population is available at the Endocrine.org site.

Founded in 1916, the Endocrine Society is the world's oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, the Endocrine Society's membership consists of over 17,000 scientists, physicians, educators, nurses and students in more than 100 countries.

Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit the Endocrine.org site. Or follow the organization on Twitter.

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