Many years have passed since testosterone was discovered and prescribed, but like all drugs, there are indications and possible side effects. The FDA states that there may be cardiovascular-related side effects from testosterone use and requires manufacturers of testosterone therapies to conduct clinical trials to assess whether they are associated with an increased risk of cardiovascular events. That's how the five-year TRAVERSE study of 5,076 participants came to be.
What is TRAVERSE study?
5,246 patients were randomized, of which 5,204 were included in the full analysis population. Of the 5,204 patients, 2,601 were randomized to receive testosterone and 2,603 were randomized to receive placebo. The overall population included 2847 patients with cardiovascular disease and 2357 patients with higher cardiovascular risk. They all reported hypogonadism and fasting testosterone levels below 300ng/dL on two occasions.
The dose is adjusted to maintain testosterone levels between 350 and 750ng/dL.
Mean duration of treatment: 21, 7+/-14.1 months
The mean follow-up time was 33.0+/-12.1 months
TRAVERSE study results
A major cardiovascular end point event occurred in 182 patients (7%) in the testosterone group and 190 patients (7.3%) in the placebo group.
The incidence of secondary endpoint events or composite primary cardiovascular endpoint events appeared to be similar in both groups. Higher rates of atrial fibrillation, acute kidney injury, and pulmonary embolism were observed in the testosterone group.
Atrial fibrillation: 3.5% in the testosterone group and 2.4% in the placebo group
Acute kidney injury: 2.3% in the testosterone group and 1.5% in the placebo group
Pulmonary embolism: 3.5% in the testosterone and 2.4% in the placebo group
What does the TRAVERSE study say?
TRAVERSE is the largest and longest-running testosterone study ever conducted. With its large sample size and duration of treatment, in addition to verifying cardiovascular problems, it also has many aspects to evaluate the improvement of sexual function, depressive symptoms, anemia and other symptoms, and the impact of testosterone on the prostate.
The TRAVERSE study showed no greater effect on major cardiovascular events than the placebo group. For these men with low testosterone levels, testosterone is safe from a cardiovascular standpoint alone. However, this does not mean that testosterone is completely free of side effects. Before using testosterone, adjust the dosage in time according to the doctor's guidance, and pay attention to its impact on the body.