TRT Not Associated with Higher Heart Attack Risk
A position paper published by the Androgen Society in Mayo Clinic Proceedings suggests that testosterone therapy is not linked to an increased risk of major adverse cardiovascular events in individuals with testosterone deficiency, despite the Food and Drug Administration’s (FDA) warning label requirements.
Following a 2013 study that received significant media attention for reporting increased cardiovascular event rates in testosterone therapy patients compared to placebo, the FDA mandated warning labels for all testosterone products in 2015. This led manufacturers to perform large-scale, multi-center studies to explore the potential cardiovascular risks associated with these therapies.
The Androgen Society’s position references five studies reporting increased cardiovascular risks. However, each study had limitations. For instance:
- Basaria et al (2010) prematurely ended the study, which focused on muscle strength in older men, due to higher cardiovascular event rates in the testosterone group. Definitions of “cardiovascular events” were unclear.
- Vigen et al (2013) had calculation errors that inflated cardiovascular event rates among testosterone therapy patients.
- Finkle et al (2014) and Budoff et al (2017) both involved participant groups with mismatched baseline cardiovascular disease burdens, reducing the applicability of their findings.
- The only meta-analysis, Xu et al (2013), included incorrect data on cardiac events, affecting its conclusions.
Conversely, randomized controlled trials cited in the paper indicate no increased risk of adverse cardiovascular events with testosterone therapy. For example, the TRAVERSE study, mandated by the FDA, included 5,246 men with testosterone deficiencies and high cardiovascular risk. Over the study period, the rate of major adverse cardiovascular events was nearly identical between the testosterone (7.0%) and placebo (7.3%) groups, with no noted differences in stroke, heart attack, or cardiovascular death rates.
Other research highlighted benefits of testosterone therapy, such as increased physical activity in heart failure patients, reduced atherosclerosis, and improved glycemic control in men with diabetes. For example, Sharma et al (2016) found associations between testosterone therapy and reduced stroke, heart attack, and overall mortality.
The Androgen Society concludes that evidence does not indicate that testosterone therapy increases the risk of cardiovascular complications, including heart attacks, strokes, or related deaths.
