The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation Patient Population-A Retrospective Database Analysis (Safety of Dabigatran vs. Warfarin in NVAF Patients)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE

  WARFARIN SODIUM
• Medical condition to be studied:
  Atrial fibrillation

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:
  28000

Study design details

• Main study objective:
  To assess the safety and effectiveness of dabigatran and warfarin in patients diagnosed with non-valvular atrial fibrillation in the Humana population.
• Outcomes:
  Stroke (hemorrhagic, ischemic, uncertain classification) measured as a dichotomous outcome. Major hemorrhage, the occurrence of any one or more of the hemorrhagic events listed below in the follow up period measured as a dichotomous outcome, Hemorrhagic stroke, Major intracranial bleeding, Major extracranial bleeding, Major GI bleeding, Major upper GI bleeding, Major lower GI bleeding, Major urogenital bleeding, Major other bleeding, TIA, MI, VTE (DVT or PE), DVT, PE, Death (all-cause)emic stroke
• Data analysis plan:
  To account for potential selection bias, the study cohorts (dabigatran and warfarin) will be matched on their baseline characteristics using the propensity score matching (PSM) method, and to account for the length of diagnosis, an additional characteristic named, “Duration of AF” will be used. o compare the occurrence of primary outcomes and secondary outcomes between dabigatran and warfarin cohorts, time to event will be investigated using non-parametric Kaplan-Meier (KM) survival analyses. Cox proportional hazards models will be implemented to evaluate the association between time to event and OAC treatment while adjusting for appropriate covariates if the propensity score matching leaves imbalance between the groups.