16 UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE The largest trial to date on testosterone replacement therapy and cardiovascular safety provides some answers and reassurance for clinicians and patients about an issue that lacked data to guide decision making. Background Prior to the publication of this study, the cardiovascular effects of testosterone replacement therapy in middle-aged and older men with hypogonadism was unclear, as previous studies provided conicting results or were too small or of an insufcient duration to provide high level evidence. This led to the FDA issuing a guidance statement which required manufacturers of approved testosterone products to conduct clinical trials to determine whether testosterone replacement therapy is associated with an increased risk of cardiovascular events. Study Design TRAVERSE is a phase 4, multicentre, double-blind, randomized, placebo-controlled, noninferiority trial that assessed the effects of testosterone replacement therapy on the incidence of cardiovascular events among men with hypogonadism and established cardiovascular disease or an elevated cardiovascular risk. The 5246 men, aged 45 to 80 years of age were given either transdermal 1.62% testosterone gel or matching placebo gel. The dose of the testosterone gel was adjusted to maintain testosterone levels between 12.14 and 26 nmol/L. Men had to have: • a preexisting cardiovascular disease or a high risk of cardiovascular disease • at least one symptom of hypogonadism • two fasting testosterone levels of less than 10.40 nmol/L - so these men had mild to moderate hypogonadism • Men with congenital or severe hypogonadism (testosterone < 3.45 nmol/L were excluded Results The mean duration of treatment was 22 months, and the duration of follow-up was 33 months. A primary cardiovascular end-point event occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; 95% condence interval, 0.78 to 1.17; P <0.001 for noninferiority). Interestingly, the incidence of prostate cancer was similar in the two groups, however the increase in prostate-specic antigen levels from baseline was greater in patients in the testosterone group than in those in the placebo group. Conclusion In middle-aged and older men with hypogonadism and preexisting cardiovascular disease or an increased cardiovascular risk, treatment with transdermal testosterone on a daily basis for approximately 2 years was noninferior to placebo with respect to the incidence of major adverse cardiac events. A quick take on the TRAVERSE trial findings: Cardiovascular Safety of Testosterone-Replacement-Therapy Published in The New England Journal of Medicine June 16 2023, VOL 389 NO.2 107-117 By Lincoff AM, Bhasin S, Flevaris P, et al.
RkJQdWJsaXNoZXIy NTIyOTQ=