United States Post-Marketing Observational Cardiovascular Safety Study in Patients taking Naloxegol (Naloxegol US Post-Market Requirement CV Safety)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Name of medicine, other:
  Moventik
• Medical condition to be studied:
  Constipation

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:
  4400

Study design details

• Main study objective:
  To assess the relative risk of MACE among naloxegol-treated patients compared with that among patients on prescription non-PAMORA OIC treatment.
• Outcomes:
  MACE defined as a composite of myocardial infarction, stroke and cardiovascular death, Individual components of MACE
• Data analysis plan:
  The primary effect estimate is the relative incidence of MACE during naloxegol exposure as compared to during comparison drug treatment. The analysis of MACE is based on the Cox proportional hazards model with an indicator for naloxegol versus comparison drug treatment as a predictor, a non-specified baseline hazard with stratification by calendar year of cohort entry, and decile of propensity score. In addition to treatment status, the predictors will include covariates that are not balanced by the propensity scores.