Testosterone does not increase cardiac risk in a group of men – 06/19/2023 – Health

The largest study ever to assess the safety of hormone replacement in men brings reassuring news for a small group of patients whose bodies do not produce enough testosterone to find that the hormone does not increase heart attacks, strokes and deaths from cardiac causes.

The new results, which come from a large clinical trial of the type considered the gold standard in medicine, do not allay all concerns. But they seem to resolve decades of conflicting findings about the cardiac safety of testosterone treatment for men who have a medical condition called androgen deficiency, or hypogonadism.

The authors emphasized that the results do not apply to the many middle-aged and older men who take testosterone offered at anti-aging centers in the hope of building muscle or increasing their energy and sex drive, often without being properly evaluated.

Rather, it only refers to the small percentage of the country’s male population, believed to be less than 10%, with a true medical diagnosis of hypogonadism or consistently low testosterone levels and symptoms that may include osteoporosis and anemia, as well as low libido.

“We’ve never had a study of more than 5,000 men followed for four years, with their heart attacks and strokes carefully tracked,” said Bradley Anawalt, an endocrinologist and professor of medicine at the University of Washington School of Medicine, who was not involved in the trial.

“The important caveat is that this should not be interpreted as a claim that testosterone does not cause heart attacks and strokes in men without hypogonadism,” he said. “It’s not a sign that it’s safe to take large amounts of testosterone for normal men.”

While testosterone levels tend to decline with age, as well as with weight gain, true hypogonadism is thought to be much less common, according to the study authors, and experts say the prevalence and incidence do not have been well studied.

The study included 5,246 men in the United States aged between 45 and 80 with this diagnosis and randomly assigned them to receive either a patch with a standard dose of testosterone or a placebo with no active ingredient.

All had heart disease or were at high risk. After an average of two years of follow-up, the researchers found that testosterone did not increase the risk of heart attacks, strokes or other deaths from heart disease.

About 7% of the men in each group experienced some type of cardiac event during the follow-up period — whether they were taking testosterone or not.

But the study identified other potentially serious complications that occurred in a small percentage of patients who received the treatment, including an increased risk of acute kidney disease, blood clots in the vessels that send blood to the lungs and a heart arrhythmia called atrial fibrillation.

“We’ve resolved an important question: Can we give testosterone to androgen-deficient men to try to help them, not harm them?” asked Steven Nissen, lead author of the study and a cardiologist at the Cleveland Clinic. “And the answer is ‘yes’.”

True hypogonadism involves low testosterone levels as well as symptoms, and often has a clear cause, such as a genetic syndrome, chemotherapy, head trauma or a pituitary tumor, Anawalt said.

The study’s findings were presented on Friday (16) at the annual meeting of the Society of Endocrinology in Chicago and published in the New England Journal of Medicine. Although the study was conducted by the Cleveland Clinic’s Clinical Research Coordinating Center and a contracted research organization, it was funded by pharmaceutical companies that produce testosterone at the request of the Food and Drug Administration (FDA).

However, the study doesn’t resolve all the safety questions that have dogged testosterone for decades. The clinical trial did not include the type of older men who attend anti-aging centers.

Many of these centers prescribe testosterone, often without testing hormone levels, according to the FDA. Only patients with a clear diagnosis of testosterone deficiency based on repeated testing and with symptoms of deficiency were included.

Long-term data are still lacking, and the study retention rate was low, with 60% of patients in each group discontinuing use of the patch before the end of the study.

The researchers took steps to explain these limitations, but said deficiencies remained.

“This wasn’t a perfect test and it doesn’t definitively answer the question it’s always been asked — and certainly not for patients other than those in the study,” Nissen said, in direct reference to men taking testosterone without a diagnosis of hypogonadism.

But the study results provide important information for physicians and patients with hypogonadism, because many of them may have been reluctant to treat the condition because of concerns about heart disease.

“This allows clinicians treating patients with hypogonadism to have less concern about whether there is a cardiovascular risk that outweighs any benefit and to focus more on which patients are likely to benefit from testosterone replacement,” said Dr Michael Lincoff, lead author of the study. , which is also at the Cleveland Clinic.

Other researchers are analyzing the data to determine how effective testosterone treatment is in relieving symptoms of hypogonadism, which include depression, osteoporosis, anemia, muscle wasting, and a bothersome condition called benign prostatic hypertrophy, which blocks the flow of urine. of sexual symptoms.

The FDA has approved testosterone products only for men whose low levels of the hormone are caused by a medical condition such as hypogonadism, but doctors may use the drug for “off-label” purposes. [de maneira diferente daquela descrita em bula aprovada pela agência regulatória].