The Endocrine Society Releases Statement on Safety of Testosterone Therapy
In response to recent studies showing an increased risk of cardiovascular disease in men taking testosterone therapy, The Endocrine Society released a statement in February recommending that physicians discuss the potential risk of cardiovascular events in middle-aged and older men who are taking or considering using testosterone therapy for age-related decline in testosterone level and symptoms.
“Physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have pre-existing heart disease,” according to The Endocrine Society statement. The Society recommends that physicians prescribe testosterone in concordance with its clinical practice guidelines on testosterone therapy in men with hypogonadism. In addition, the Society recommends use of a standardized monitoring plan to help individualize therapy and reduce the risk of adverse events.
The Society called for large-scale, prospective, randomized controlled trials to assess the risk/benefits of testosterone therapy in men with age-related declines in testosterone levels. Specifically, the Society is awaiting safety data on testosterone therapy from the National Institutes of Health-funded T Trial. This ongoing randomized trial is designed to monitor for cardiovascular events among other outcomes in approximately 800 men age 65 and older with low testosterone levels and accompanying symptoms who are treated with testosterone therapy.
What Does the Current Evidence Show?
“Concern regarding potential cardiovascular adverse events associated with testosterone use was raised in 2010 when a signal was noted in a randomized clinical trial in progress, leading to the premature termination of the study,” commented Tamara L. Wexler, MD, PhD, an endocrinologist specializing in reproductive and neuroendocrinology, and an Attending in Medicine at Massachusetts General Hospital, Boston, MA. “Two recent large retrospective observational trials suggest there is a risk for some cardiovascular events in certain populations, prompting The Endocrine Society statement,” she said.
“These results—reviewed in the recent EndoScan—should be viewed in the context of existing data on the benefits and risks of testosterone use,” Dr. Wexler said. “Evidence to date—including randomized controlled trials demonstrating benefits of testosterone levels in the ‘normal’ range, and observational studies suggesting enhanced cardiovascular risk in some patients, and improved mortality in others—highlights the need for randomized trials on the effects of testosterone replacement, including the T trial noted by the Endocrine Society as well as the TEAM trial.”
FDA Is Evaluating the Safety of Testosterone Therapy
Likewise, the U.S. Food and Drug Administration (FDA) also announced plans to evaluate the risk of stroke, heart attack, and death in men taking FDA-approved testosterone therapy.
“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete,” according to the FDA.
“Awareness and further study of both the benefits and the potential risks of testosterone use are increasingly urgent with the rise in prescriptions for testosterone therapy in older men, including those who may not meet guidelines,” commented Dr. Wexler. “A testosterone value in the lower range may not be sufficient reason to initiate treatment, given the lack of information on the value of testosterone replacement in aging under different conditions, and particularly the lack of reliable safety data. Specific subject inclusion criteria and subject and patient characteristics are important in determining whether study results are relevant to a given individual,” she said.
“Before considering a trial of testosterone in any given patient, the signs and symptoms of hypogonadism in that patient should be measured and then monitored, and the potential benefits and risks of testosterone use discussed,” she said.
The Endocrine Society. The Risk of Cardiovascular Events in Men Receiving Testosterone Therapy. An Endocrine Society Statement. February 7, 2014. https://www.endocrine.org/~/media/endosociety/Files/Advocacy%20and%20Outreach/Position%20Statements/Other%20Statements/The%20Risk%20of%20Cardiovascular%20Events%20in%20Men%20Receiving%20Testosterone%20Therapy.pdf. Accessed March 17, 2014.
U.S. Food and Drug Administration. FDA evaluating risk of stroke, heart attack, and death with FDA-approved testosterone products. January 31, 2014. http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm. Accessed March 17, 2014.