The FDA warns that testosterone prescriptions are only approved for men with low testosterone due to certain medical conditions.
Vladimir Burger/Getty Images/Science Photo Libra
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Vladimir Burger/Getty Images/Science Photo Libra
The FDA warns that testosterone prescriptions are only approved for men with low testosterone due to certain medical conditions.
Vladimir Burger/Getty Images/Science Photo Libra
in 2014 time magazine made the cover a story titled Menopause?!, It marked the rise of the $2 billion testosterone industry, which marketed testosterone as a way to prevent age-related declines in sexual function, energy and strength.
As interest grew, so did questions about safety. small study Researchers have shown that testosterone can improve muscle strength in older men, but they also unexpectedly found a higher rate of adverse cardiovascular events such as heart attacks. In 2015, the FDA required manufacturers to add: warning label To inform consumers about potential risks. Prescription testosterone use began to decline.
A new study out Friday may ease the minds of those interested in the treatment. It found that some men had low testosterone levels and received the prescription. testosterone gel There was no higher heart attack or stroke rate compared to men who took a placebo to increase their sex hormone levels.
“The results of this study provide encouraging substantial evidence that appropriately prescribed testosterone replacement therapy does not appreciably increase the risk of death from cardiovascular disease,” said the study authors. Dr. Michael Rinkoff of the Cleveland Clinic. Result is, New England Journal of Medicine.
(This study did not evaluate an over-the-counter dietary supplement containing testosterone, which is not regulated like a drug.)
New study aims to better understand testosterone’s effects on cardiovascular risk, senior study author explains Dr. Stephen Nissen, a cardiologist at the Cleveland Clinic. Still, he interprets the results cautiously.
“While this trial does provide some evidence that testosterone treatment may be safe for men with low testosterone levels, these results should not be used to justify widespread prescribing. No,” says Nissen.
of FDA Announces Treatment It should be reserved for men with laboratory confirmed low testosterone. Nissen said he was “concerned” that the results could be interpreted by bodybuilders and athletes looking to improve performance as a green light for testosterone use. “I really think it’s a potential risk,” says Nissen.
Nissen emphasizes that all participants had a history of cardiovascular disease or were at high risk for cardiovascular disease. Symptoms of hypogonadism, a medical term for not producing enough testosterone. The study involved approximately 5,200 men between the ages of 45 and 80 who were assigned to use either a placebo gel or testosterone gel applied to the skin daily for 22 months.
Seven percent of men who used testosterone gel experienced a serious cardiac event, such as a heart attack or stroke. Among placebo users, 7.3% had a major cardiac event. And given that all participants were at increased risk of heart disease, the results suggested that testosterone did not increase risk. While this may be encouraging, Nissen points to other safety concerns found during the study, including an increased risk of cardiac arrhythmias in men taking testosterone.
“I didn’t expect that,” says Nissen. In addition, the risk of renal injury and pulmonary embolism was slightly increased. The study authors conclude that the findings “support current guidelines that testosterone should be used with caution” in men who have had previous thrombotic events.
This study was funded by a group of testosterone manufacturers including: AbbVie, the makers of Androgel, Product used in research. Marketing materials include common side effects and risks associated with our products, including possible increased risk of prostate cancer. In the new study, 12 patients (0.5%) in the testosterone group developed prostate cancer, compared with 11 patients (0.4%) in the placebo group. This trial was independently conducted by the Cleveland Clinic Clinical Research Coordinating Center.
The new findings are “very encouraging,” he says. Kambiz Tajikarimiis a board-certified urologist in the Washington, DC area who treats people with sexual dysfunction. I will prescribe testosterone. including pellets It has been marketed to many patients as a biologically identical hormone replacement therapy, and he says he uses it himself.
“I was very tired,” said Tajkarimi, who is in her early 50s. He says he has more energy now, and he attributes that to the testosterone pellets. “I think it’s a really beneficial treatment.”
However, testosterone clinical trials have shown mild or discreet symptom relief and benefits of testosterone replacement therapy. Dr. Steven Woloshin One of the key findings of the new study, the Dartmouth Institute for Health Policy and Clinical Practice said, was that about 60% of the men who took part in clinical trials stopped taking testosterone during the trial. Says. Many said their symptoms continued.
“That’s another way of saying it didn’t work, or didn’t work enough. [men] To see the benefits,” Wolothin says.
Prior research including Research published in 2016 Testosterone has been shown to cause Improving sexual function But a closer look at previous research shows a very modest effect, says Wolothin. For example, a 0.6-point improvement on a 13-point scale for sexual function and a 0.5-point improvement on a 45-point mood scale, “many men will not notice this effect,” Woloshin said. Also, the feeling of fatigue did not improve.
Overall, Wolothin said he fears the study’s findings could revitalize interest in testosterone replacement therapy among those who may not benefit from it. “This is not the Fountain of Youth,” Wolothin says. “You will start to feel the effects of aging.”
Nissen agrees. “Men want to feel like they were young,” he says. But of course you can’t turn back the hands of the clock.
