Testosterone Cardiovascular Risk Among Some Men Not Seen in Study

The findings of a new study raise more questions about the potential link between cardiovascular risks and testosterone replacement drugs, such as Androgel, Testim, Axiron and other popular gels, patches and injections. 

Following several studies published over the past year that suggested side effects of testosterone drugs may increase the risk of heart attacks among some men, researchers from the Intermountain Medical Center Heart Institute now report that they were unable to find a link between testosterone replacement therapy and cardiovascular risks among men between 53 and 71 with low testosterone levels.

The findings were announced in a press release on November 18 and presented in Chicago at the annual 2014 meeting of the American Heart Association this week. The study has not yet been published or peer-reviewed.

Researchers looked at data on 5,695 men who were treated at intermountain Healthcare hospitals. Over a period of three years, the study was unable to find evidence that this group of men experienced more heart attacks, strokes or other cardiovascular events while taking Low-T drugs.

The study comes about a year after concerns about potential testosterone cardiovascular risks emerged following the publication of research in the Journal of the American Medical Association (JAMA), which found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events.

The JAMA study was followed by another study published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

Amid increasing concerns about the cardiovascular risks within the medical community, other research has found that the drugs are currently widely over-prescribed, with many individuals receiving “Low T” drug prescriptions when they have normal testosterone levels or without ever having their blood tested.

In September, an FDA advisory committee recommended that testosterone drug manufacturers conduct extensive clinical trials to determine the actual cardiovascular risks of testosterone medications.

The FDA panel, whose vote is not binding on the agency, also recommended that the labels for the drugs be updated to clearly state that the use of testosterone should be limited to men who actually suffer hypogonadism that can be medically confirmed, as opposed to age-related drops in testosterone that are common among all men as they get older.

The latest study’s author acknowledge that their findings may raise more questions that still need to be answered by more extensive research.

“With this study we are getting closer to defining the true associations between testosterone treatment and cardiovascular risks or benefits,” lead researcher Dr. Jeffrey Anderson, a cardiologist at Intermountain, said in a press release. “While this study provides reassurance about the safety of using supplementation to move from low to normal levels of testosterone, more studies, particularly large randomized studies, are needed.”

Over the past year, hundreds of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug lawsuits have been filed in courts throughout the U.S., alleging that the drug makers failed to adequately research their medications or warn about the potential cardiovascular risks.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases in June 2014, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

The first Androgel lawsuits are expected to go to trial in late 2016, which may help gauge how juries will respond to certain evidence and testimony that could be repeated throughout thousands of cases nationwide if testosterone settlements or another resolution for the litigation is not reached before then.