A new study shows that short-term testosterone may be safe

June 10, 2022 – A new study shows that men with low testosterone levels who received testosterone replacement therapy for three months to a year had no more heart-related problems than similar men who received a placebo.

The researchers say the findings — which come from an analysis of data collection from many smaller studies — offer some reassurance that testosterone replacement therapies are safe for the heart when eligible men take them for a short time.

Testosterone levels decline as men age, and some individuals diagnosed as having low testosterone levels (hypogonadism) may qualify for testosterone replacement therapy.

But some experts warn that this new ‘meta-analysis’ didn’t follow men long enough, and doctors and patients should wait for the results of a very large study currently underway — which compares five years of treatment with testosterone gel versus a sham gel in more than 5,000 men — before extracting any Conclusive conclusions about whether testosterone is actually safe for the heart.

This is because some previous studies have found that testosterone replacement therapy is associated with an increased risk of heart attack or stroke. But other studies have not come to this same conclusion.

However, since 2014, the US Food and Drug Administration has required companies to place a warning label on testosterone products about potential heart-related risks.

The agency stresses that testosterone products are approved for use only by men who lack or have low testosterone levels in conjunction with an associated medical condition.

For some older men only?

“If your doctor thinks you need testosterone, rest assured that the chance of serious side effects including heart problems is very low,” says researcher Shana Anne Jayasina, MD, of Imperial College, London, in the UK.

“However, all medications including testosterone are dangerous if taken when not needed,” he says, adding that “older men may continue to benefit from testosterone, but only if they have…low testosterone levels.” .”

Cardiologist Irene de Michos says, “Testosterone levels typically decline with age in men and [guidelines say] We don’t need to put someone on testosterone replacement just to address age-related low testosterone.”

“If you’re a guy with low testosterone…and you have symptoms — low libido, low energy, low muscle mass, low facial body hair, you might discuss with your doctor whether you might be a candidate for testosterone replacement therapy,” Michos said. , who is of Johns Hopkins University School of Medicine in Baltimore, MD.

But if men have “a strong family history of heart disease in their family or if they have high blood pressure or high cholesterol, I would still be cautious about using testosterone therapy in them,” she says.

However, “if men are less likely to have cardiovascular disease and they are already symptomatic – we don’t just treat a number – what we know now is that it appears to be reasonably safe in the short term, but we really lack the data on long-term safety” .

Best study so far

In their new analysis — which will be presented at the Endocrine Society meeting in Atlanta on Monday, June 13 and recently published in Healthy Longevity Lancet – The researchers combined data from 35 studies conducted from 1992 to 2018 with a total of 5,601 men with clinically low testosterone levels and an average age of 65.

The men received either acetosterone or a placebo for 3 months to a year (except for one 3-year study), with an average treatment lasting 9.5 months.

Using these data, the rate of any heart-related event during the study was not significantly different between men who received testosterone therapy (7.5%) versus men who received placebo (7.2%).

There was also no significant increase in the risk of death, stroke, arrhythmia, coronary heart disease, heart failure, or heart attack among the men who took testosterone versus placebo.

This is the “most comprehensive study to date investigating the safety of testosterone therapy for hypogonadism,” the researchers wrote in their study.

Men with hypogonadism should be advised that there is no current evidence that testosterone therapy increases cardiovascular risk in the short to medium term. They concluded that the long-term safety of testosterone has yet to be established.

Michus agrees. We must wait for results [the long-term study] to be published before the widespread use of testosterone replacement therapy is considered.” Lancet.

The longer study “was specifically designed to determine the risk of heart attack, stroke, or death from cardiovascular disease, during five years of testosterone therapy, versus placebo, and results are expected to be announced later this year.”

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