When it comes to matters of health, determining fact from fiction online can quickly become a confusing wormhole. Take for example testosterone replacement therapy (TRT) and the misconception it causes heart attacks. TRT can improve quality of life for those suffering from low testosterone by alleviating symptoms like fatigue, muscle weakness, erectile dysfunction, low libido. However, there has been conflicting data about its safety muddying the online waters.
From 2010 to 2014, four studies were published that reported increased cardiovascular events in men who received testosterone prescriptions. This created fear, uncertainty, and doubt, ultimately leading to the FDA placing a warning label on all testosterone products regarding the risk of cardiovascular events. However, these studies were later found to be rife with critical flaws such as poor design, inclusion errors, statistical correction errors, and gross data mismanagement.
This research and others like it were not robust enough to determine true heart risks ultimately leading to the TRAVERSE trial, which was published June 2023 in the New England Journal of Medicine. For deeper insight into TRT’s potential impact on cardiovascular health, we turned to Wellcore Physician Assistant, Ryan Lester for a balanced analysis of the latest research.
The TRAVERSE trial is the most important clinical trial to date assessing the relationship between TRT and the risk of having a cardiovascular event like a heart attack and stroke. The study was a randomized, double-blind, placebo-controlled trial targeting men aged 45-80 with total testosterone levels less than 300ng/dL and pre-existing cardiovascular disease or who were at high risk for developing cardiovascular disease. Nearly 5,200 patients were randomized to receive testosterone gel or a placebo over the course of about two years. Participants were then followed for an additional three years.
Based on the results of the TRAVERSE trial, it is clear that TRT is a safe and effective treatment for men with low testosterone levels. The results showed that TRT did not increase or decrease the risk of cardiovascular events. In fact, the reporting of increased atrial fibrillation (nonfatal heart arrhythmia) and acute kidney injury events were so small they are clinically irrelevant. The increase in blood clots in the TRT was not statistically significant. There was also no increase in the risk of prostate cancer in the group receiving testosterone cream.
The authors of the study stressed that men should take supplemental testosterone only when it is medically necessary — when a patient has a testosterone deficiency confirmed by a blood test and symptoms such as reduced body and facial hair, loss of muscle mass, low libido, hot flashes, poor concentration, irritability, depression and thinning bones. Other findings on efficacy outcomes, including sexual function, depressive disorder, fractures, anemia, and diabetes, are expected to be published later this year.
While the study is well researched, to mitigate discourse surrounding TRT safety, Lester believes the ideal study would run longer than two years and include a randomized controlled testosterone injections trial. He also recommended that researchers avoid conflicts of interest, such as accepting sponsorship from treatment manufacturers, as the TRAVERSE trial was led by pharmaceutical companies.
The Bottom Line
The study supports the majority of clinical trials conducted throughout the past three decades that demonstrate TRT at physiologic doses does not increase the risk of a heart attack, stroke or prostate cancer. In fact, a majority of the studies demonstrate low testosterone increases risk of a cardiovascular event and developing prostate cancer.
Simply put, this study demonstrates that testosterone gel, used in these doses, in this specific group of men, does not increase OR decrease the risk of a cardiovascular event. Further research needs to be conducted to assess the use of TRT in healthier men and their risk of developing the most common chronic diseases that lead to disability and death - cancer, dementia and diabetes.
It is also important to note that TRT is not right for everyone. Men who are considering TRT should speak with a hormone specialist about the risks and benefits to determine if it is the right treatment for them.
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