Testosterone and Cardiovascular Risk: The TRAVERSE Trial and Results from the New FDA Label Change скачать в хорошем качестве

Testosterone and Cardiovascular Risk: The TRAVERSE Trial and Results from the New FDA Label Change

Mohit Khera, MD, MBA, MPH, Professor of Urology and F. Brantley Scott Chair of Urology, Baylor College of Medicine, Houston, Texas, discusses evolving understanding of testosterone therapy and cardiovascular risk. In this 13-minute presentation, Dr. Khera focuses on the pivotal TRAVERSE trial and the recent announcement regarding class-wide labeling changes for testosterone products. History of CV Events and Testosterone Therapy Dr. Khera traces the history of concern of cardiovascular risks with testosterone therapy. He details that early studies—such as Molly Shores’ 2006 work—showed that low testosterone was associated with higher mortality, particularly due to cardiovascular events. However, between 2010 and 2014, several flawed studies suggested that testosterone therapy could increase cardiovascular risk. These studies prompted the FDA to issue a warning in 2015 restricting labeled indications to men with specific medical conditions, excluding age-related hypogonadism. The TRAVERSE Trial The TRAVERSE trial launched out of these concerns. This large, randomized, placebo-controlled trial enrolled over 5,200 men aged 45 to 80 with low testosterone levels and existing cardiovascular risk. Over a mean follow-up of 33 months, the trial found no increase in cardiovascular events among men treated with testosterone compared to placebo. Importantly, no increased risk of prostate cancer or worsening of lower urinary tract symptoms was observed. TRAVERSE Trial Update in 2025 As a result, in February 2025, the FDA updated the labeling for testosterone products. While maintaining existing restrictions around age-related use, the FDA removed language from the Black Box related to increased risk of cardiovascular outcomes. The FDA now requires inclusion of TRAVERSE results in labeling. Following Ambulatory Blood Pressure Monitoring (ABPM) studies, the FDA requires product-specific information on increased blood pressure for testosterone products with completed ABPM studies. This is in addition to warnings about increased blood pressure across all testosterone products that currently lack such warnings. Dr. Khera emphasizes the clinical impact of these changes. He notes that previous warnings led many high-risk men to avoid testosterone therapy despite potential benefits. He advocates for further research into the role of testosterone normalization in reducing cardiovascular risk. He also encourages a reevaluation of lingering concerns around prostate health.