TRAVERSE Trial Update

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TRAVERSE Trial Update

Mohit Khera, MD, MBA, MPH, presents the latest updates from the TRAVERSE Trial, examining the cardiovascular effects of testosterone therapy.

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Mohit Khera, MD, MBA, MPH, presents the latest updates from the TRAVERSE Trial, examining the cardiovascular effects of testosterone therapy. This presentation is an update to Dr. Khera’s Results from the TRAVERSE Trial lecture, which was presented to the Grand Rounds in Urology audience in August 2023.

Dr. Khera begins by reviewing the history of the TRAVERSE Trial and its initial results regarding the impact of testosterone therapy on cardiovascular health. He outlines the design of the TRAVERSE Trial, which concluded in January 2024 with a final enrollment count of 5,246 men.

In addition to the original secondary and tertiary endpoints regarding cardiovascular safety and prostate safety, Dr. Khera discusses other secondary endpoints in the trial. These endpoints were sexual function, depression, bone fractures, diabetes, and anemia.
Dr. Khera concludes by delving into the final results of testosterone therapy on all endpoints in the trial. He notes that the results indicate that testosterone therapy does not significantly worsen BPH symptoms and may protect against the development of anemia. However, he notes that testosterone therapy may raise the risk of bone fractures and pulmonary embolisms.

 

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Testosterone Therapy and the Risk of Cardiovascular Disease

Abstract The debate over the cardiovascular (CV) implications of testosterone therapy (TT) have resulted in diverging safety recommendations and clinical guidelines worldwide. This narrative review synthesizes and critically evaluates long-term studies examining the effects of TT within the...

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*The TRAVERSE trial, a landmark study unique in its capacity to evaluate CVD events, contributes valuable insights into the short-term safety of TT at lower physiological levels. However, the long-term effects and implications of mid to high physiological testosterone levels are not yet fully understood




4. Conclusion

The therapeutic approach for TT for symptomatic hypogonadism and low testosterone levels associated with aging, obesity, and systemic illness presents challenges. These conditions are intricately linked with CVD outcomes and may confound the relationship between low testosterone and CVD. Although observational studies suggest an association between low testosterone and increased risk of CVD, results from testosterone supplementation are inconsistent. RCTs indicate that short-term TT at standard replacement is not associated with increased CVD risk. Nevertheless, the cardiovascular sub-study of T Trials observed increases in NCP and CAC, signaling the need for further investigation into potential long-term implications of TT.

The TRAVERSE trial, a landmark study unique in its capacity to evaluate CVD events, contributes valuable insights into the short-term safety of TT at lower physiological levels. However, the long-term effects and implications of mid to high physiological testosterone levels are not yet fully understood. The trials’ limitations — achievement of only low-normal testosterone levels, high discontinuation rates, brief follow-up period, and high loss to follow-up rate — suggest that the findings should be interpreted with caution. It is important to avoid generalizing the safety of TT based on these results alone and to approach the extrapolation of TRAVERSE’s conclusions to higher dosages or longer-term therapy with caution.

The decision to initiate TT requires a nuanced approach, which must account for current gaps in evidence regarding CV safety. A personalized assessment and management of CVD risk factors is essential for older men with known CVD. The CV effects of exogenous testosterone, when given to maintain physiological levels, remain to be fully explored. In this regard, an important question remains the identification of male patients with symptomatic hypogonadism who may benefit from TT. This topic continues to be the subject of ongoing debate. Hopefully, future trials will provide clarity on whether TT confers beneficial, neutral, or adverse cardiovascular effects in middle-aged and older men. Until definitive evidence surfaces, clinical practice should exercise caution and prioritize individualized care with informed discussions regarding the potential CV implications of TT.