Risk of Metabolic and Cardiovascular Adverse Events With Abiraterone or Enzalutamide Among Men With Advanced Prostate Cancer

J Natl Cancer Inst. 2022 Aug 8;114(8):1127-1134. doi: 10.1093/jnci/djac081.

Abstract

Background: Abiraterone and enzalutamide are the most common oral agents for the treatment of men with advanced prostate cancer. To understand their safety profiles in real-world settings, we examined the association between the use of abiraterone or enzalutamide and the risk of metabolic or cardiovascular adverse events while on treatment.

Methods: Men with advanced prostate cancer and their use of abiraterone or enzalutamide were identified in a 20% sample of the 2010-2017 national Medicare claims. The primary composite outcome was the occurrence of a major metabolic or cardiovascular adverse event, defined as an emergency room visit or hospitalization associated with a primary diagnosis of diabetes, hypertension, or cardiovascular disease. The secondary composite outcome was the occurrence of a minor metabolic or cardiovascular adverse event, defined as an outpatient visit associated with a primary diagnosis of the aforementioned conditions. Risks were assessed separately for abiraterone and enzalutamide using Cox regression. All statistical tests were 2-sided.

Results: Compared with men not receiving abiraterone, men receiving abiraterone were at increased risk of both a major composite adverse event (hazard ratio [HR] = 1.77, 95% confidence interval [CI] = 1.53 to 2.05; P < .001) and a minor composite adverse event (HR = 1.24, 95% CI = 1.05 to 1.47; P = .01). Compared with men not receiving enzalutamide, men receiving enzalutamide were at an increased risk of a major composite adverse event (HR = 1.22, 95% CI = 1.01 to 1.48; P = .04) but not a minor composite adverse event (HR = 1.04, 95% CI = 0.83 to 1.30; P = .75).

Conclusion: Careful monitoring and management of men on abiraterone or enzalutamide through team-based approaches are critical.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Androstenes
  • Benzamides
  • Humans
  • Male
  • Medicare
  • Nitriles
  • Phenylthiohydantoin / adverse effects
  • Prostatic Neoplasms, Castration-Resistant* / drug therapy
  • Treatment Outcome
  • United States / epidemiology

Substances

  • Androstenes
  • Benzamides
  • Nitriles
  • Phenylthiohydantoin
  • enzalutamide
  • abiraterone