Risk of cardiovascular events with degarelix versus leuprolide after biochemical relapse of prostate cancer: Exploratory analysis of a randomized controlled trial.

Abstract

151 Background: Androgen deprivation therapy (ADT) has been associated with increased cardiovascular (CV) risk in men. A pooled analysis of phase 3 trials comparing LHRH agonists with degarelix in PCa patients indicated a lower risk of CV events or death in those treated with degarelix. We now report the incidence of non-fatal CV events in men with PCa and pre-existing CV disease (CVD) treated with degarelix or leuprolide in the CS37 trial. Methods: CS37 was a prospective, randomized trial comparing intermittent (n=175) and continuous (n=50) degarelix with continuous leuprolide (n=178) in patients with biochemical relapse of PCa in the United States. CV events were retrospectively analyzed up to Month 12 (intermittent arm events censored at Month 7). Cox regression models were used to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI). Results: 143 men (35%) had pre-existing CVD at baseline; 88 treated with degarelix and 55 treated with leuprolide. For degarelix and leuprolide treatment arms, median age (range) was 75 (51–88) and 73 (53–89) years and median BMI (range) 28.0 (17.7–40.7) and 30.1 (23.5–48.3) kg/m2, respectively. A slightly higher proportion of men treated with leuprolide than degarelix had a Gleason score of 7–10 (35 [64%] vs 46 [52%]) and slightly more men treated with degarelix vs leuprolide had hypertension (31 [35%] vs 15 [27%]), diabetes (70 [80%] vs 39 [71%]) and used statin medication (67 [76%] vs 36 [65%]) at baseline. The proportion of men who smoked or had hypercholesterolemia at baseline was similar between treatment arms. During the observation period, a subsequent CV event occurred in 3 (3.4%) men treated with degarelix and 8 (14.5%) treated with leuprolide (HR=0.22; 95% CI 0.05–1.03, p=0.054). Conclusions: Retrospective analysis of men with pre−existing CVD in CS37 identified a lower risk for subsequent CV events in men treated with degarelix vs leuprolide. The difference in CV event risk was seen within 12 months of treatment initiation. Our analysis adds to previous data on CV risk with ADT and supports consideration of CV risk factors when choosing a drug for androgen deprivation.