🔍 Objective: The safety of testosterone-replacement therapy has been a topic of concern, especially in older men with heart disease risks. Does this therapy add any cardiovascular burden? Let’s dive into the findings from the TRAVERSE study.
🏥 Design: Over 5,000 men aged between 45 and 80 with preexisting or a high risk of cardiovascular disease were part of this multicenter, randomized, double-blind, placebo-controlled trial. All participants reported symptoms of hypogonadism and showed low testosterone levels.
💊 Treatment Groups: Men either received daily testosterone gel (with dose adjustments to maintain specific testosterone levels) or a placebo gel.
❤️ Key Outcomes:
- Primary Endpoint: Focus was on first occurrence of major adverse cardiac events (death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Findings? 7.0% in the testosterone group and 7.3% in the placebo group experienced such events, suggesting no significant difference between the two.
- Secondary Endpoint: This considered major adverse cardiac events, plus coronary revascularization. Results mirrored primary endpoint findings, further solidifying the main conclusions.
- Additional Observations: The testosterone group saw a higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism.
💡 Takeaway: For middle-aged to older men with hypogonadism and a predisposition or existing cardiovascular disease, testosterone-replacement therapy appears to be as safe as a placebo in terms of major cardiac events. However, some caution is advised given the observed increase in certain other complications.
🔗 Reference: TRAVERSE ClinicalTrials.gov
Sponsor’s Note: The TRAVERSE study was funded by AbbVie and others. We express gratitude for their support in this crucial research!