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“Many in the general public are using testosterone supplements for various medical problems, including low sex drive and mood disorders, which are not life-threatening. These men may unknowingly be placing themselves at a higher risk for cardiovascular disease.” Kristen Sueoka, MD, resident physician, University of California, San Francisco (EurekAlert, July 1, 2010)
“The numbers of older men receiving testosterone are large and increasing. We owe it to our patients and their families as well as our physician colleagues to have much better data and guidelines for the administration of this critical hormone.” William J. Bremner, MD, PhD, Department of Medicine, University of Washington, Seattle (New England Journal of Medicine, July 8, 2010)
Testosterone Linked to Heart Problems
Treatment Improved Strength, Muscle Mass, and Mobility
Study Halted Due to Bad Effects
We have two new studies of older men, one involving natural levels of testosterone and the other supplemental. Both studies found a correlation between testosterone and heart disease. Higher levels of testosterone are associated with higher rates of heart and other problems.
A large multi-location study found that community-dwelling older men with higher natural levels of testosterone are more likely to have heart attacks and other cardio problems. The study was presented by Kristen Sueoka, MD, at The Endocrine Society’s 92nd Annual Meeting in San Diego.
Testosterone Tracks Risk
Study participants were 65 or older and included 697 healthy men who were not receiving testosterone therapy. All of them had blood tests to determine their testosterone levels. They were then divided into four equal groups based on their testosterone range and followed for nearly four years to observe rates of heart attack, chest pain, and other heart disease warning signs.
During the follow-up period 100 men, or about 14 percent, had coronary disease events. After adjusting for other risk factors, such as elevated cholesterol, they found that men whose total testosterone was in the highest quarter (over 495 nanograms per deciliter) had more that twice the risk of heart disease, compared to men in the lowest quartile (below 308 ng/dl).
Other important measures of testosterone also showed a close relationship between testosterone and coronary heart disease.
“Many in the general public are using testosterone supplements for various medical problems, including low sex drive and mood disorders, which are not life-threatening. These men may unknowingly be placing themselves at a higher risk for cardiovascular disease,” Dr. Sueoka told The Endocrine Society meeting.
“One day testosterone measurement may be used to help predict which men are more likely to develop cardiovascular disease,” she opined.
We need more studies to confirm this finding, which brings us to the second study involving testosterone supplementation. This study was published online June 30, 2010, in The New England Journal of Medicine. It’s more focused and complex than the first study.
Testosterone Gel Problematic
Lead author Shehzad Basaria, MD, and his team from Boston and Harvard Universities reported that testosterone supplementation may build strength and muscle mass in older men, but may also carry risks of heart problems.
A total of 209 community-dwelling men, 65 or older, with limited mobility and testosterone between 100 and 350 ng/dl were randomly assigned to receive placebo gel or testosterone gel daily. The testosterone group was given a dosage designed to achieve testosterone levels of 500-1000 ng/dl.
Limited mobility, common in geriatric men, is a predictor of disability and poor quality of life, even death. Some studies have also shown low testosterone to be a risk factor for death from all causes.
Participants also had a high incidence of hypertension, diabetes, high cholesterol, and obesity.
In short, the subjects had low testosterone and multiple risk factors. They had difficulty walking two blocks on a flat surface or climbing 10 stairs.
They sound like likely or typical candidates for testosterone supplementation. The gel manufacturer, however, said otherwise: “We believe these men are not representative of the typical testosterone replacement therapy population.”
“Testosterone is not currently approved for older men with age-related decline or mobility problems,” senior researcher Shalender Bhasin, MD, explained.
Approved or not, the testosterone gel worked. “As compared with the placebo group, the testosterone group had significantly greater improvement in leg-press and chest-press strength and in stair climbing while carrying a load,” the researchers reported. Unfortunately, the testosterone gel group also developed more problems.
“A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events,” the study reported. One man in the testosterone group died of a suspected heart attack.
The testosterone group also had higher rates of breathing and skin problems.
The adverse effects were significant enough to call a halt to the study. “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,” the researchers related.
“I think the study raises important questions about the safety of giving testosterone to older individuals,” Dr. Bhasin told Reuters in a telephone interview. Doctors thinking about prescribing testosterone for their older patients should realize that the treatment may pose a serious risk, Bhasin said.
Editorial Review of Basaria Study
An editorial in the July 8, 2010 New England Journal of Medicine by William J. Bremner, MD, PhD, (Department of Medicine, University of Washington, Seattle) commented on the Basaria study and testosterone replacement for older men.
Bremner begins with some background.
Men generally have a gradual decline in average testosterone level as they age. Some men, however, maintain testosterone levels similar to those of healthy young men—even as they age.
Changes that come with decline in testosterone level include decreases in muscle mass, strength, bone mass, and sexual function, and increases in body fat, fatigue, and depression.
Limited mobility is a predictor of disability, poor quality of life, and death.
Unfortunately, testosterone therapy is a mixed bag; it can both help and hurt, which complicates treatment.
Dr. Bremner calls the Basaria study “surprising,” explaining that “many studies with cumulative numbers of subjects greater than those reported here have not detected substantial increases in cardiovascular risk during testosterone administration, including many studies in which subjects achieved the same or higher serum testosterone levels, some for longer periods of time.”
As Basaria and his colleagues acknowledged, “there is a clear possibility that their results are due to chance,” Bremner added. The sample, although larger than in most previous trails, was small. The number of adverse effects was also small. The heart related events were not anticipated and were not documented as well as they could’ve been; they were, however, verified from medical records or by direct examination.
Dr. Bremner also observed that the baseline characteristics of the subjects in the testosterone group—limited mobility with hypertension, diabetes, high cholesterol, and obesity—may have exacerbated the adverse effects. Frail men with limited mobility are more likely to have undiagnosed heart disease and other problems.
All of the limitations noted by Dr. Bremner were acknowledged in the Basaria report.
While the study may sound a note of caution, “it certainly should not deter investigators from proceeding with additional, larger studies of testosterone administration in well-characterized groups of older men to more clearly outline benefits and risks,” he wrote. “Similarly, it should not prevent clinicians from prescribing testosterone replacement for [men with low levels]…, although it should provide some new caution about the administration of testosterone in older men who have an extensive history of cardiovascular disease and immobility.”
“The numbers of older men receiving testosterone are large and increasing. We owe it to our patients and their families as well as our physician colleagues to have much better data and guidelines for the administration of this critical hormone,” Bremner concluded.
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I am asked from time to time whether I use steroids or testosterone replacement therapy. The answer is “No.” If there comes a time when I might need testosterone supplementation, I would discuss all aspects, good and bad, with my doctor or doctors before deciding on the best course of action. I hope never to confront that situation. My default choice will always be healthy eating and regular exercise, the only option with no downside.
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