Comparative Effectiveness and Safety between Warfarin and Dabigatran Using Real World Claims data of Japanese Non-valvular Atrial Fibrillation 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
• 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:
  9000

Study design details

• Main study objective:
  To compare the effectiveness (stroke/SE) and safety (major bleeding) in patients with atrial fibrillation and newly treated with dabigatran and warfarin in the real world Japanese setting using a claims database
• Outcomes:
  stroke, systemic embolism, Bleeding related events, myocardial infarction
• Data analysis plan:
  This study plans no formal hypothesis testing. The planned analyses are descriptive in nature and results are to be interpreted in an exploratory manner. 1:1 Propensity score matching (PSM) was conducted to to address potential channelling bias. Outcomes will be assessed in the PSM sample.Patient characteristics prior to and after propensity score matching will be described stratified by treatment groupNumber of observed events, number of patient years, the corresponding incidence rates and their 95% confidence intervals (CIs) will be reported.Dabigatran and warfarin outcomes will be compared by estimating the hazard ratios (HRs) for the outcomes and their CIs using Cox regression.Kaplan-Meier curves for event-free survival will be estimated.