Study Links Testosterone Treatments to Heart Attacks, Strokes, Death

A recent study of more than 8,000 veterans with low testosterone found that the low-T vets who received testosterone replacement therapies had a higher incidence of heart attacks, stroke and death than low-T vets who did not receive testosterone treatments.

The study involved 8,709 male veterans with low testosterone (<300 ng/dL) who also had undergone a coronary angiography within the previous seven years (2005-2011). Coronary angiography is a test to check for blockages, build-up and other problems in the coronary arteries, veins and heart chambers. The tests are typically performed on patients who are demonstrating symptoms of heart disease. The group had a high level of co-existing illnesses, including coronary artery disease, high blood pressure, high cholesterol and diabetes.

The study raises serious concerns about testosterone replacement therapies and treatments for patients with heart disease as well as for patients with signs or risk factors for heart disease.

The study was published in the Journal of the American Medical Association (November 2013). A simultaneous JAMA news release summarized the study this way: “Among a group of men who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of death, heart attack, or ischemic stroke.”

Although all of the men presumably were demonstrating signs or symptoms that called for a coronary angiography, many of them did not have coronary artery disease. Interestingly and importantly, the study did not find a statistical difference in adverse effects between the men with and without coronary artery disease.

Even before the study, the risks associated with testosterone therapies were in question. As the study states in its introduction, “The effects of testosterone therapy on cardiovascular outcomes and mortality are unknown. “

Findings

The study found that the low-T patients who were receiving testosterone replacement treatment had a 26% likelihood of heart attack, stroke or death within three years after the coronary angiography. Low-T patients who were not receiving testosterone treatment had a 20% chance of heart attack, stroke or death.

The difference calculates to a 30% higher risk for the patients taking the testosterone drugs. Patients in both groups had similar blood pressure, low-density lipoprotein (cholesterol) levels and use of secondary prevention medications, so those factors do not explain the 30% increase.

“These findings raise concerns about the potential safety of testosterone therapy,” the study found. “[It is] important to inform patients that long-term risks are unknown and there is a possibility that testosterone therapy might be harmful.”

Criticisms

Some scientists criticized aspects of the study. One scientist observed that there was not sufficient data to explain why some of the low-T men were receiving testosterone therapies and others were not. It was also observed that 36% of the hormone replacement patients were receiving testosterone via injections, which create peaks and troughs in hormone levels that could skew the statistics.

Some earlier studies had suggested an opposite conclusion: that testosterone therapies improve cardiac risk factors. However, the authors of the new study point out that many of those earlier studies involved a smaller number of patients, patients of different ages, and patients with varying durations of testosterone treatment, and that earlier studies did not control well for confounding factors.

In the JAMA issue which reported on the study, Anne R. Cappola, MD, editorialized:

“Perhaps the most important question is the generalizatibility of the results of this study to the broader population of men taking testosterone. There is only anecdotal evidence that testosterone is safe for these men. …

“The clinical question about which men should receive testosterone therapy is controversial … What is missing from the literature are data from randomized trials that include a sufficient number of men for an adequate amount of time to assess the long-term benefits and risks of testosterone therapy.”

Sounding a similar note, cardiologist Harlan Krumholz observed in the New England Journal of Medicine:

“Amid the onslaught of ads promoting testosterone, this study provides cautionary information, and reminds us that chasing surrogate outcomes, like testosterone levels, may actually cause harm. We need outcomes studies to understand better the safety of these products.”

For More Information

For more information, see “Testosterone Replacement Therapies, Testosterone Treatments” on this website.

If you or a loved one has received testosterone replacement treatment and have experienced harms or losses, including heart attack, stroke, infertility or death, you should learn about your legal rights.

  • Did you medical provider prescribe testosterone treatment without testing you for low T?
  • Did you have a history of heart disease at the time you were prescribed testosterone treatment?
  • Did you have plaque buildup, artery blockage, high cholesterol, diabetes and/or obesity at the time you were prescribed testosterone replacement therapy?

For a free consultation, contact Hasbrook & Hasbrook by telephone (866-416-4737), email (cth@hasbrooklaw.com) or use our website contact form: Contact Us.