Testosterone Replacement Update

Q: Contrary to the FDA warnings and class action lawsuits, didn’t we read a lot of positive news about prescribed testosterone last year?

A: Definitely. Two studies on physician-supervised testosterone replacement therapy (TRT) made the news in 2016 and both have beneficial implications for the relationship between TRT and your heart’s health.

The first study, reported on April 4th at The Endocrine Society’s annual meeting in Boston, looked at 100 obese Australian men with low testosterone levels (<346 ng/dL) who were initially placed on a very low calorie diet for 10 weeks, then put on a weight-maintenance diet. Forty-nine men were randomly assigned to receive injected TRT and the other 51 received a placebo (82 men finished the double-blind trial). While the men were fairly heathy, 20% were diabetic and 10% had heart disease.

At the end of the 10-week very low calorie diet phase, the groups weren’t far off in the amounts of weight they lost. However, at the end of the 56-week study there was an important difference between the two groups. Researcher Dr. Ng Tang Fui noted, “Significant loss of fat mass was seen when testosterone treatment was added to a strict diet program. Men receiving testosterone also maintained lean mass, which was lost in men who were dieting and receiving placebo.” That’s pretty awesome. “There is an epidemic of obesity and related functional hypogonadism, yet testosterone treatment remains controversial,” said researcher Dr. Mathis Grossmann. “This study shows for the first time that, among obese men with lowered testosterone, testosterone treatment augmented the diet-induced loss of total and visceral fat mass and prevented the diet-induced loss of lean mass.” In other words, TRT helped the men lose more fat and keep muscle that would otherwise have been lost. With obesity being a major cardiac risk factor, and 40% of obese men reportedly having low testosterone, could TRT become a routine part of many men’s weight-loss protocols?

The second study, conducted by researchers at Intermountain Medical Center and presented on April 3rd at the American College of Cardiology’s Annual Scientific Session, looked at the relationship between TRT and coronary artery disease. The researchers recruited 755 men aged 58 to 78, all with severe coronary artery disease, and randomly divided them into three groups. One group was given high-dose TRT, one got moderate-dose TRT, and one got a placebo. After one year, 64 placebo patients had adverse events, but only 12 participants with moderate testosterone doses and 9 with high doses had cardiovascular events. After three years, 125 placebo patients had major cardiovascular events, compared to 38 medium-dose and only 22 high-dose TRT patients. The startling outcome was that TRT patients were 80% LESS likely overall to suffer a major adverse cardiovascular event – a stroke, heart attack or death.

“The study shows that using testosterone replacement therapy to increase testosterone to normal levels in androgen-deficient men doesn’t increase their risk of a serious heart attack or stroke,” said cardiologist Dr. Brent Muhlestein, co-director of cardiovascular research at the heart institute, in a press release. “That was the case even in the highest-risk men — those with known pre-existing heart disease.” The new study corroborates and augments 2015 research at the same institute which found that TRT did not increase the risk of heart attack or stroke in men with low testosterone and no prior history of heart disease.

None of this should come as a surprise. The few studies claiming to link testosterone with heart problems run contrary to 40 years’ worth of research and accumulating evidence. Some men may not be good candidates for TRT, and the researchers involved in both studies expressed the need for further study as there’s no ironclad guarantee that future research will corroborate the findings. Still, the burgeoning body of solid evidence that TRT is quite GOOD for the hearts of most men with low testosterone is compelling. FDA’s 2015 black box warning on testosterone being a risk factor for heart attacks and stroke in most men seems clearly misplaced. If you’re a plaintiff’s class action lawyer deeply invested in the Multi-district Testosterone Litigation claiming that using testosterone products for low testosterone increases the risk of heart attack and stroke, you won’t particularly like what the research actually shows.


Adapted from Rick’s “Busted!” column in Muscular Development magazine.  © 2016, All Rights Reserved.