Studies: no Heart Risk From Testosterone Therapy

Testosterone therapy doesn't seem to increase a man's risk of heart attack or stroke, a pair of new studies suggests.

Dr. Pawan Ptel, who led the study and is an academic doctor at Regions Hospital St. Paul in Minnesota, said that "Testosterone therapy, in any form, whether pills, injections or gels," does not seem to have detrimental cardiovascular effects.

These studies will be presented at next week's American College of Cardiology annual meeting in San Diego. Research presented at medical conferences is usually considered preliminary and not published in peer-reviewed journals.

The two studies were released a day after the U.S. Food and Drug Administration issued a warning about the overuse of testosterone -boosting drugs by aging baby boomers trying to use hormone therapy to turn back the clock.

According to Tuesday's announcement by FDA, all prescription testosterone products will need to be accompanied with a warning label indicating a potential increased risk of stroke and heart attack.

Patel indicated that the FDA may prematurely warn against testosterone therapy based on his research. Before we place a warning about testosterone therapy, there will need to be a long-term clinical study.

The natural decline in testosterone as men age is due to the loss of testosterone. Low testosterone is often treated with testosterone therapy -- the so-called "low T" as cited by many ad campaigns. According to a news release from the ACC, low testosterone can affect mood, memory and bone density, as well as metabolism.

According to the FDA, testosterone replacement therapy use has grown significantly in the five years since 2009, when it was used by 1.3 million people. This compares with 2.3 millions patients who were treated in 2009. The ACC stated that testosterone therapy is used by nearly one-quarter of the men aged over 60.

FDA warned that the FDA had reported testosterone being widely used to treat symptoms of low testosterone in men. This was not for any other reason than ageing. This use is not safe or effective.

FDA said that certain studies in the past have shown an increase risk of death, stroke and heart attacks due to testosterone treatments, but others didn't.

As recently as 2013, a study of Veterans Administration patients revealed a 30 percent increased risk in heart attacks and strokes among men taking testosterone therapy, said Dr. Richard Becker, chief of cardiovascular health and disease at the University of Cincinnati College of Medicine.

Becker, the University of Cincinnati Heart, Lung and Vascular Institute director, said, "The risk of getting heart failure was greater if they were known to have them."

Patel and his coworkers based their findings on 29 studies that had previously been done on testosterone therapy. These included nearly 123,000 men.

While the analysis revealed a 17 percent increased risk of heart-related disease associated with testosterone therapy, the risk was not statistically significant, the study authors said.

The second report was based on a community-based study from a Wisconsin health care system, in which researchers tracked health data from 7,245 men with low testosterone levels between 2011 and 2014. These data were derived from 15 hospitals in Aurora Health Care and 150 clinics.

After adjusting for risk factors, researchers found that there was no difference between men with low testosterone and those who had received testosterone therapy.

"The reassurance we get from this analysis in the community setting is that testosterone replacement therapy in patients with low serum levels is not causing any harm, even if it is not providing much cardiovascular benefit [in this patient population]," study senior author Dr. Arshad Jahangir said in the ACC news release.

Jahangir, Director of Aurora Health Care’s Center for Integrative Research on Cardiac Aging (CIRCA), said the results "will ease anxieties about this treatment" and give physicians some information on which to base their prescribing choices.

The University of Cincinnati's Becker asserted that neither study should be taken as definitive proof that testosterone therapy is safe for heart health.

Patel's study, for example, found an increase in risk of heart disease. However, it was not statistically significant. Becker explained that if you have a 17 percent increase in your risk, this might be significant.

Becker stated that some men are concerned about the possibility of testosterone therapy speeding up prostate cancer progression. Becker said prostate cancers could feed on testosterone.

Becker suggested that only low-trigestol levels are a reason to consider testosterone therapy. Becker said that even in these cases, the potential benefits and risks must be carefully weighed by a physician.

Becker, Patel and others agreed that it is necessary to conduct a large clinical study to find out if testosterone therapy can cause damage to the heart.

Patel explained that "to get the best answers, we need long term clinical trials to compare testosterone and placebo."