Testosterone gel linked to heart problems
Wed Jun 30, 2010 6:23pm EDT
BOSTON (Reuters) - Testosterone treatments may build muscle mass in older men, but they may carry a risk of heart problems in people with poor mobility, U.S. researchers said on Wednesday.
The Massachusetts study, reported online by the New England Journal of Medicine, was halted after six months because the men using a hormone gel were developing so many heart, breathing and skin problems compared to patients applying a placebo gel to their shoulders or upper arms every day.
"I think the study raises important questions about the safety of giving testosterone to older individuals," Dr. Shalender Bhasin of the Boston University School of Medicine said in a telephone interview.
Levels of testosterone, the so-called male hormone, decline with age in men. Supplementing it in healthy men can build muscle mass and strength and lower the risk of disability.
The new test was the first to assess its effectiveness in men over 65 who already had mobility problems such as difficulty walking two blocks or climbing 10 stairs.
The 209 volunteers, with an average age of 74, also tended to suffer from obesity, diabetes, high blood pressure and high cholesterol at the start of the test. "One would expect that from a frail, older population," said Bhasin.
Recipients of the testosterone gel, sold under the brand name Testim by Auxilium Pharmaceuticals, became better at walking up stairs and performing chest- and leg-press exercises.
But by the time the study was terminated, 23 patients in the testosterone group and five in the placebo group had experienced a bad side effect such as fainting, chest pain or heart attack. One man in the testosterone group died of a suspected heart attack.
The numbers were too small to be statistically significant and the side effects encompassed a lot of different diagnoses, which may mean that chance played a role in the results.
Yet men receiving testosterone had more serious side effects and more side effects considered to be life-threatening, the researchers said, lasting for three months after the trial ended.
"The study was designed to study mobility limitation, a common syndrome with the elderly that predicts disability, poor quality of life and mortality," Auxilium said in a statement.
"We believe these men are not representative of the typical testosterone replacement therapy population."
Bhasin was surprised by the finding.
"Testosterone is not currently approved for older men with age-related decline or mobility problems," he said. However it is approved by the U.S. Food and Drug Administration for other patients.
Doctors thinking of prescribing testosterone for their older patients should realize that the treatment may pose a serious risk, Bhasin said. "There may be safety issues that they should weigh in their decision," he said.
Testosterone causes salt and water retention and that could have been a factor, the researchers said. The National Institute on Aging, which paid for the trial, also noted that the men in the study may have been getting exceptionally high doses of testosterone. Auxilium said they were getting double to triple the recommended dose.
(Editing by Maggie Fox and Mohammed Zargham)
Published at www.nejm.org June 30, 2010 (10.1056/NEJMoa1000485)
Adverse Events Associated with Testosterone Administration
Shehzad Basaria, M.D., Andrea D.
Background Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.
Methods Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.
Results A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.
Conclusions In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981 [ClinicalTrials.gov] .)
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