Cardiovascular outcomes among patients with castration-resistant prostate cancer: A comparative safety study within US real world databases

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ABIRATERONE ACETATE

  ENZALUTAMIDE
• Medical condition to be studied:
  Cardiovascular disorder

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  Among patients with castration-resistant prostate cancer (CRPC), compare new users of abiraterone acetate plus predniso(lo)ne to new users of enzalutamide with respect to hospitalization for the cardiovascular morbidity outcomes of ischemic stroke, hemorrhagic stroke, heart failure, and acute myocardial infarction
• Outcomes:
  Incidence of cardiovascular morbidity including ischemic stroke, hemorrhagic stroke, heart failure, and myocardial infarction
• Data analysis plan:
  Characteristics of patients within each treatment cohort will be described during the time preceding the index date. For calculation of incidence rates, the number of persons with each event, the incidence proportion, and the incidence rate adjusted for person-time according to each at-risk time window for each study population and each of the outcomes of interest will be reported. A new user cohort design will be used to conduct comparative analyses if the exposed (abiraterone) population can be appropriately matched to the selected comparator population (enzalutamide) based on a defined set of patient and clinical characteristics, using propensity score matching. Cox proportional hazards will be used to estimate the hazards of each outcome in the target cohort, relative to the comparator cohort. The number of persons, amount of time-at-risk, and number of outcomes in each cohort will also be reported. Additionally, Kaplan-Meier plot swill be generated.