OBJECTIVES: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) receptor agonists is used to induce castration and prostate cancer (PC) cell death. Studies have shown an association between GnRH agonists and increased cardiovascular disease (CVD) risk; ~30% of men with PC have known CVD; cardiovascular mortality is the leading cause of death. In 2010, the Federal Drug Administration required new safety information to the labels of GnRH agonists warning of increased risk of CVD events in men receiving these medications for PC. We assessed the occurrence of major adverse cardiovascular events (MACE) and associated healthcare resource utilization (HCRU) in men with PC receiving agonist ADT.

METHODS: Men receiving ADT with ≥2 claims for a diagnosis of PC were identified in the Marketscan Commercial and Medicare Supplemental Database (1/1/2009-12/31/2018). Index date was the first ADT claim; patients had to be continuously enrolled for 12 months pre- and >2 months post-index. The occurrence of MACE (myocardial infarction, cerebrovascular accident, unstable angina, thromboembolism, percutaneous coronary intervention, and/or coronary bypass graft) was assessed over the study period. Post-period all-cause HCRU was evaluated for patients with and without MACE.

RESULTS: The study included 41,986 men; mean age was 70.1 (SD:10.3) years, and median duration of follow-up was 22.8 months. A total of 10,402 patients (24.8%) had a MACE during the study period (8.7% pre-index and 20.6% post-index). Patients with a MACE had three times the number of post-index inpatient admissions per-patient-per-month compared to patients without MACE (0.06[SD:0.10] vs. 0.02[0.06], p<0.001).

CONCLUSIONS: CVD is a known and important risk for patients with PC treated with GnRH agonists; 20% of patients in this analysis had a MACE following ADT. These patients were more likely to be hospitalized than patients without a MACE. Evaluating CVD history and risk in advanced PC patients when selecting treatment could help to reduce MACE and HCRU.