The largest study to date to assess the safety of hormone replacement therapy for men is heartening news for a small group of patients whose bodies don’t produce enough testosterone, and the hormone is responsible for heart attacks, strokes, and cancer. It was found not to increase cardiac death.
New results from a large clinical trial of the sort considered the gold standard of medicine do not dispel all concerns. But the studies appear to resolve decades of conflicting findings on the cardiac safety of testosterone treatment for men with a condition called androgen deficiency or hypogonadism.
The authors said the results do not hold true for many middle-aged and older men who take testosterone, which is offered at anti-aging centers in hopes of building muscle or boosting energy and libido. and often underappreciated. Rather, the problem concerns only a small portion of the country’s male population, believed to be in the low single digits. True medical diagnosis of hypogonadismor if you have consistently low testosterone levels and symptoms such as osteoporosis, anemia, or low libido.
“No study has followed more than 5,000 men for up to four years and closely tracked heart attacks and strokes,” says endocrinologist and professor of medicine at the University of Washington Bradley Anawalt, Ph.D. He was not involved in the trial.
“An important caveat is that testosterone should not be construed as not causing heart attack or stroke in men without hypogonadism,” he said. “It’s not that high doses of testosterone are safe for normal men.”
Testosterone levels tend to decline with age and weight gain, the study authors said, but true hypogonadism is thought to be less common, and experts are skeptical about its prevalence and incidence. He said that not enough research has been done on
The study enrolled 5,246 diagnosed men aged 45 to 80 nationwide and randomly assigned them to receive either a patch containing a standard dose of testosterone or a placebo without the active ingredient. . All men had heart disease or were at high risk for heart disease.But after an average of two years of follow-up, the researchers found that testosterone No increased risk of heart attackdeath from stroke or other heart disease.
About 7 percent of the men in each group experienced some kind of cardiac event during the follow-up period, whether they were taking testosterone or not.
However, the study identified other potentially serious complications that occur at low rates among treated patients, including increased risk of acute kidney disease, blood in the lungs, and These include blood clots in blood vessels that carry blood, and cardiac arrhythmias called atrial fibrillation.
“We have solved one important question: can men with androgen deficiency be given testosterone to help them without harming them?” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said. “And the answer is yes.”
True hypogonadism involves not only symptoms but also low testosterone levels, and often has clear causes such as genetic syndromes, chemotherapy, head trauma and pituitary tumors, says Annawoldt. Stated.
The findings were presented Friday at the Endocrinology Society’s annual meeting in Chicago and published in The New England Journal of Medicine. The trial was conducted by the Cleveland Clinic Coordinating Center for Clinical Research and a contract research organization, but was funded by the pharmaceutical company that manufactures testosterone at the request of the Food and Drug Administration.
But the study doesn’t address all the safety questions that have haunted testosterone for decades. The trial did not include older men who flock to anti-aging centers. Many of those centers prescribe testosterone, but often do not test for hormone levels.according to the FDA Only patients with a definite diagnosis of testosterone deficiency based on repeat testing and symptoms of deficiency were included.
Long-term data are still lacking, and trial retention is low, with 60% of patients in each group discontinuing patch use before the end of the trial.
The researchers said they took steps to consider these limitations, but shortcomings still exist.
“It’s not a perfect study, it’s not going to conclusively answer any questions at any given time, and it certainly isn’t for different patients than the ones who took part in this study,” Dr. Nissen said. He pointed to a man who was ingesting it. Diagnosis of hypogonadism.
However, many physicians and patients may be reluctant to treat hypogonadism due to concerns about heart disease, so the results of this study provide important information for physicians and patients with hypogonadism. do.
“This reduces concerns among physicians who have been treating patients with hypogonadism about whether the cardiovascular risks outweigh any benefits, and which patients are more likely to benefit from testosterone replacement. You will be able to focus more,” said Dr. Michael Rinkoff. He is the lead author of the study and also works at the Cleveland Clinic.
Other researchers have found that testosterone treatment may help alleviate symptoms of hypogonadism, including depression, osteoporosis, anemia, loss of muscle mass, and a nasty condition called benign prostatic hyperplasia that blocks the flow of urine. We are analyzing the data to determine how effective it is. for sexual symptoms.
The Food and Drug Administration only approves testosterone products for men with low testosterone levels due to medical conditions such as hypogonadism, but doctors can use the drug for other “off-label” purposes. It recognized.
The agency reviewed testosterone replacement therapy in 2010 after testosterone clinical trials were stopped after patients taking testosterone began having heart attacks, and in 2015 the FDA ordered testosterone manufacturers to Requires clinical trials to assess risk.
The agency also added a so-called black-box label to testosterone products, warning of a possible increased risk of heart attacks and strokes.
Dr. Shallender Bhasin, an endocrinologist at Brigham and Women’s Hospital in Boston and co-principal investigator of the study, said testosterone therapy really improved sexual function and resolved other symptoms of hypogonadism. We are analyzing the test results to see if
“There is folklore that testosterone improves sexual function, but even in that area there were only three to four randomized trials, and most trials were only three to six months in duration,” he said. , noted that “there was a substantial placebo effect.” sexual symptoms. “
Dr. Bhasin’s research, which has yet to be published, will look specifically at the effects of testosterone on the prostate, bone fractures, and diabetes progression.
