Testosterone Replacement Therapy Doesn’t Increase Heart Risk: Study
Testosterone Replacement Therapy Doesn’t Increase Heart Risk: Study

By George Citroner

Men’s testosterone levels have been declining for decades, and nobody knows why exactly.

study from 2021 found that total testosterone levels have been declining in young adult men in recent decades. Testosterone deficiency currently affects about 20 percent of adolescent and young adult males.

Another study published in 2020 further supports these findings, indicating a “highly significant” age-independent decline in total testosterone during the first and second decades of the 21st century that cannot be solely attributed to rising obesity rates.

Consequently, testosterone replacement therapy (TRT) has garnered increased interest as a potential solution, despite earlier concerns about its impact on heart health.

Now, a new study published in June investigating the potential heart risks associated with TRT among men at high risk of or living with cardiovascular disease found only a slight increase in heart risk for these individuals, suggesting that the previous concerns about TRT and heart health may not be as significant as previously believed.

No Clinically Meaningful Difference in Heart Risk

The recent phase 4 randomized controlled trial included 5,246 men aged 45 to 80 with preexisting or high risk of cardiovascular disease and symptoms of low testosterone. Participants exhibited two instances of fasting testosterone levels below 300 nanograms per deciliter.

On average, testosterone is about 466 nanograms per deciliter for men aged 20 to 44 (pdf).

During the trial, participants were randomly assigned to receive either a daily transdermal 1.62 percent testosterone gel, with dosages adjusted to maintain levels between 350 and 750 ng/dl, or a placebo for up to 33 months.

Adverse events included 12 cases of prostate cancer (0.5 percent) in the testosterone group and 11 cases (0.4 percent) in the placebo group. Patients in the testosterone group also experienced a more significant increase in prostate-specific antigen (PSA) levels than those in the placebo group.

Researchers found no “clinically meaningful” differences in the incidence of cardiovascular events between the trial groups. They did note a slightly higher occurrence (0.9 versus 0.5 percent) of pulmonary embolism, atrial fibrillation, and acute kidney injury in the testosterone group.

This brings into question the U.S. Food and Drug Administration’s (FDA) “black box warning” on TRT, cautioning that it’s associated with increased cardiovascular risk.

“Many of us have been eagerly awaiting these study results for years,” Dr. William Berg, assistant professor of urology at Stony Brook Medicine, told The Epoch Times. “We’re very excited to see these results come out.”

Health Risks Associated With Low Testosterone Levels

“We’ve known for a long time that having low testosterone itself is a significant health risk,” Dr. Berg said. “Particularly cardiac disease and bone health.”

Low testosterone levels have been associated with early-onset osteoporosis, increasing the risk of fractures. People with low testosterone also tend to have higher rates of heart disease. Additionally, having low testosterone levels may put you at risk for diabetes and becoming obese.

“So for a particular subset and group of people, having low testosterone can be dangerous,” Dr. Berg added. “Which is why, for many years, many people who are interested in men’s health have felt that if you have low testosterone, treating you should actually improve these risks, not harm you.”

Dr. Berg said that studying a group of men already at high risk for heart-related illnesses was the most appropriate approach to determining the safety of TRT. “Because, let’s say they only did the study with people who were healthy,” he added. “Then the argument would be that they didn’t really examine people who are at risk of having heart attack.”

The findings indicate that even in individuals at risk of a heart attack, administering testosterone does not increase that risk, according to Dr. Berg.

TRT and Prostate Cancer: Debunking Misconceptions

This study didn’t seek to address how TRT affects the prostate or prostate cancer risk, but the FDA warns that testosterone replacement increases the risk of benign prostatic hyperplasia (BPH), causing the prostate to grow in size.

“That’s not all men, it’s only some men,” Dr. Berg said. “And as the name states, it’s benign.”

Dr. Berg added that while it’s usually not a problem, some men may notice they’re urinating more frequently if they’ve been on testosterone replacement for several years.

“As far as prostate cancer, that’s been up for debate and discussion for many years,” he said. “People used to believe that giving testosterone put you at risk for getting prostate cancer. The current belief has changed significantly in that we don’t believe testosterone replacement puts you at increased risk for prostate cancer.”

He added that there are several health care providers—him included—who actually give testosterone replacement to people who have had a diagnosis of prostate cancer.

“The low-risk and the very low-risk patients, even with active cancer, are still candidates for testosterone replacement,” Dr. Berg said. “If you have high-risk prostate cancer, that might be a different scenario, but it likely doesn’t cause it to progress either.” He added that patients can safely be on testosterone replacement if they are closely monitored.

Why did doctors’ perceptions of TRT and prostate cancer risk change? “There’s something called the saturation hypothesis,” Dr. Berg said, “which means that even low levels of testosterone in your blood, as far as the cancer is concerned, it’s the same as high levels of testosterone.”

According to Dr. Berg, this means that the cancer is no more affected by a testosterone level of 800 as it would be one of 200.

“It’s going to do what it’s going to do,” he said. “But what men notice is that when their testosterone is higher, they feel better. So we don’t need men to be feeling unwell, even if they have a diagnosis of prostate cancer.”

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