A Look at the Latest Research on Cardiovascular Safety and TRT
Hey folks! Buckle up for an adventurous journey into the world of testosterone replacement therapy (TRT). We’re exploring the TRAVERSE study, a testosterone packed thrill ride of cardiovascular safety research.
Middle Aged Men, Cardiovascular Disease, and a Testosterone Gel
Imagine a world where middleaged men, aged 45 to 80, are on a quest to conquer the perils of hypogonadism (aka low testosterone). Our protagonists were 5246 brave souls, all facing cardiovascular disease or the lurking threat of it.
They were randomly assigned to either a magical 1.62% testosterone gel or a placebo (a.k.a. the Gel of Imagination). The mission? To keep their testosterone levels between 350 and 750 ng/dl and uncover the cardiovascular secrets of TRT.
The Big Question: Does Testosterone Cause Heart Risk in Men?
The burning question was whether TRT would save these middle aged heroes or leave them with broken hearts. Specifically, researchers were looking for the first occurrence of:
- Death from cardiovascular causes
- Nonfatal myocardial infarction (heart attack)
- Nonfatal stroke
To satisfy their curiosity, they followed these testosterone toting warriors for an average of 33 months.
The Results
Primary Cardiovascular End Point: Only 7.0% of the testosterone gel group suffered major cardiovascular events, versus 7.3% in the placebo group. Phew! TRT didn’t significantly increase the risk, proving its noninferiority (HR, 0.96; 95% CI, 0.78 to 1.17; P<0.001).
Secondary Cardiovascular End Point: Adding coronary revascularization into the mix didn’t shake things up much (HR, 1.02; 95% CI, 0.86 to 1.21).
But Wait, There’s More! Beware of the Unexpected Side Effects
The testosterone gel came with a few surprise plot twists:
Atrial Fibrillation: More common in the TRT group (3.5% vs. 2.4% with placebo; P = 0.02). Our heroes were skipping heartbeats like a romantic comedy.
Pulmonary Embolism: Watch out for this villain—24 cases in the testosterone group vs. 12 in the placebo.
Acute Kidney Injury: The TRT warriors weren’t immune to kidney troubles (2.3% vs. 1.5%; P = 0.04).
Should You Use Testosterone?
The TRAVERSE study brings some closure to the epic TRT tale. Despite a few plot twists, testosterone gel proved noninferior to placebo regarding major adverse cardiac events.
However, like any superhero story, TRT isn’t without its nemeses. Men with hypogonadism need to wield this therapy carefully, especially if they’ve got preexisting cardiovascular issues.
Sources:
2. UChicago Medicine Sleep Loss and Low Testosterone
Stay tuned for the next exciting chapter in TRT research.