Degarelix did not reduce the risk of major adverse cardiovascular events (MACE) when compared with leuprolide in patients with prostate cancer and cardiovascular disease, according to a real-world study published in JAMA Network Open.
Researchers used electronic health record and administrative claims data to emulate the ongoing PRONOUNCE trial (ClinicalTrials.gov Identifier: NCT02663908) and compare the cardiovascular safety of degarelix and leuprolide.
The study included 7800 patients with prostate cancer and cardiovascular disease who were receiving degarelix or leuprolide and met eligibility criteria for PRONOUNCE.
After propensity-scored matching, 1113 patients each received degarelix and leuprolide. For both groups together, the median age was 76 years (range, 70-81 years), 69.9% of patients were White, and the median Charlson comorbidity index score was 5 (range, 3-8).
The researchers found no significant difference in the risk of MACE between the 2 groups. The event rate for MACE, per 100 person-years, was 10.18 in the degarelix group and 8.6 in the leuprolide group (hazard ratio [HR], 1.18; 95% CI, 0.86-1.61; P =.30).
Similarly, there were no significant differences between the groups when it came to myocardial infarction (HR, 1.16; 95% CI, 0.60-2.25; P =.66), stroke (HR, 0.92; 95% CI, 0.45-1.85; P =.81), or angina (HR, 1.36; 95% CI, 0.43-4.27; P =.60).
However, there was a significantly higher risk of death from any cause with degarelix. The death rate, per 100 person-years, was 7.43 in the degarelix group and 4.99 in the leuprolide group (HR, 1.48; 95% CI, 1.01-2.18; P =.046).
“Comparison of these data with PRONOUNCE trial results, when published, will help enhance our understanding of the appropriate role of using real-world data to emulate clinical trials,” the researchers concluded.
Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Wallach JD, Deng Y, McCoy RG, et al. Real-world cardiovascular outcomes associated with degarelix vs leuprolide for prostate cancer treatment. JAMA Netw Open. 2021;4(10):e2130587. doi:10.1001/jamanetworkopen.2021.30587