FRIDAY, June 16, 2023 (HealthDay News) — Testosterone substitute therapy is secure for many men with heart problems who even have been diagnosed with a low testosterone disorder, a brand new clinical trial has concluded.

The trial found that testosterone substitute didn’t raise these patients’ incidence of heart attack, stroke or heart-related death in a gaggle of men with each heart problems and hypogonadism — a condition by which low testosterone levels have led to specific health problems.

“For men with heart disease or in danger for heart disease, taking testosterone — when given in appropriate doses and punctiliously monitored — didn’t increase the danger of heart-related events like heart attack, stroke or death from heart-related causes,” said senior researcher Dr. Steve Nissen, chair of cardiovascular medicine with the Cleveland Clinic.

Nonetheless, researchers warn the outcomes usually are not a green light for “Low-T Centers” to tout testosterone substitute for any healthy man, including those whose levels of the male hormone are declining naturally with age.

“My nightmare really is that we’ll see ads on television that say, ‘Cleveland Clinic says that testosterone is secure. Now, come on in and we’ll provide you with your testosterone.’ That’s not a superb consequence from this study,” Nissen said.

The trial also identified certain health risks with testosterone substitute therapy that ought to be taken under consideration before prescribing the treatment, Nissen added.

“There are some people I might not give it to,” Nissen said. “Men which have had a history of atrial arrhythmias [heart rhythm problems] or any type of clotting problems probably shouldn’t get it.”

The. trial was prompted by the U.S. Food and Drug Administration’s response to the proliferation of “Low-T Centers” throughout the nation. The outcomes were published June 16 within the Latest England Journal of Medicine.

Prescriptions for testosterone substitute therapy in the US increased between 1.8- and fourfold in the course of the previous twenty years, in keeping with a 2017 meta-analysis within the journal European Urology Focus.

Data presented to an FDA advisory committee in 2014 showed that the variety of patients taking testosterone leaped from nearly 1.3 million in 2010 to about 2.3 million in 2013, Nissen noted.

Testosterone can stimulate an excessive amount of red blood cell production, which may increase a person’s risk of developing a blood clot. Such clots could cause a heart attack, stroke or pulmonary embolism.

In March 2015, the FDA ordered manufacturers of approved testosterone products to conduct clinical trials to find out whether the therapy could increase the danger of heart attacks or strokes.

For this latest trial, Nissen and his colleagues recruited greater than 5,200 men 45 to 80 with clinically diagnosed hypogonadism and either an existing heart problem or high risk of heart disease.

The boys all had two fasting blood tests which showed low testosterone, in addition to a number of symptoms related to hypogonadism. These symptoms included decreased libido, decreased spontaneous erections, fatigue or decreased energy, depressed mood, decreased frequency of shaving or hot flashes.

“We’re coping with men who may benefit from testosterone,” said Dr. Robert Eckel, a past president of the American Heart Association who was not involved within the study. “Two-thirds of those patients had diabetes. It’s a gaggle of men who’re people you have got to be hesitant to do anything with that’s not evidence-based.”

The boys were randomly assigned to take day by day doses of either a testosterone gel or a placebo gel for nearly two years, to see whether testosterone treatment affected their heart health.

After about three years of follow-up, researchers concluded that the variety of major heart-related health events were in regards to the same between the testosterone and placebo groups.

Heart attack, stroke, or heart-related death occurred in 182 patients within the testosterone group versus 190 within the placebo group.

Nonetheless, researchers did notice some serious uncomfortable side effects within the testosterone group.

Men taking testosterone were more prone to develop a heart rhythm problem, kidney damage or a pulmonary embolism:

• Twice as many men taking testosterone suffered a pulmonary embolism (24 versus 12 for placebo).
• Arrhythmias developed in 134 testosterone patients versus 87 placebo patients (5.2% versus 3.3%).
• Acute kidney injury occurred in 60 testosterone patients versus 40 placebo patients (2.3% versus 1.5%).

Nissen and Eckel agreed that doctors prescribing testosterone therapy should screen for these risk aspects, and possibly not give it to men with arrhythmias, kidney problems or clotting issues.

“That’s a cautionary note, but I believe the study has really clarified this issue,” said Eckel, a professor of drugs emeritus with the University of Colorado School of Medicine. “Can we give testosterone safely to hypogonadal men who’re proven to be hypogonadal? I believe for probably the most part, the reply is yes.”

But Eckel reiterated Nissen’s point that this shouldn’t open the floodgates for low testosterone treatment.

“A number of men seek testosterone therapy due to all of the promoting, that testosterone gives them more muscle mass, more strength, higher sex drive and sex performance,” Eckel said. “This isn’t what we’re talking about.”

Nissen also warned that the longer-term health impacts from testosterone therapy remain unclear.

“We studied just for 21.7 months. We didn’t study these patients for five years,” Nissen said. “What happens should you take testosterone longer-term? That’s an unanswered query.”

Nissen is skeptical that any follow-up clinical trials will likely be done to see whether testosterone substitute therapy is secure for average aging men whose male hormone levels are naturally declining.

“I don’t think anybody’s going to do it. All these drugs are actually generic. There’s not likely any impetus from sponsors to pay for it,” Nissen said. “The NIH could do such a study but frankly, aging is a traditional process. I believe most men need to just accept the incontrovertible fact that a number of the things that they may do after they were younger, they’ll’t do after they’re older.

“Attempting to fix aging with a tonic called testosterone might be not smart,” Nissen noted.

Men concerned with low testosterone could be higher off addressing all the opposite health problems that may contribute to male hormone decline, said Dr. Romit Bhattacharya, associate director of Massachusetts General Hospital’s Cardiac Lifestyle Program in Boston.

“We all know that it’s related to quite a few other health indicators, including poor-quality food regimen, lack of physical activity, obesity and diabetes,” Bhattacharya said. “Low testosterone appears to be a chronic metabolic health condition that’s largely as a consequence of this trend of worsening cardio-metabolic health, worsening dietary trends, worsening exercise trends, increasing obesity and increasing insulin resistance and diabetes.

“We’ve got to be desirous about, are we putting a Band-Aid on a much larger problem?” Bhattacharya said. “I would really like to see men who’ve noticed that they’ve low testosterone, they’re feeling perhaps less energetic, less libido, have erectile dysfunction, to take into consideration what processes led them there.”

The trial was funded by drugmakers AbbVie, Acerus Pharmaceuticals, Endo Pharmaceuticals and Upsher-Smith Laboratories.

More information

The Mayo Clinic has more in regards to the potential advantages and risks of testosterone therapy.

SOURCES: Steven Nissen, MD, chair, cardiovascular medicine, Cleveland Clinic; Robert Eckel, MD, professor of drugs emeritus, University of Colorado School of Medicine, Aurora; Romit Bhattacharya, MD, associate director, Massachusetts General Hospital’s Cardiac Lifestyle Program, Boston; Latest England Journal of Medicine, June 16, 2023