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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

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
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AA03) warfarin

  warfarin
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Inclusion criteria; 1. >18 year-old with confirmed diagnosis of NVAF (International ; Classification of Diseases (ICD) 10 code I48) ; 2. New starters of either dabigatran or warfarin; 3. No prescription of other OACs for 12 months prior to the index date, ; defined as the first prescription of OACs (the period is defined as ; baseline period); 4. Having an index date between 14 March 2011 to 30 June 2016; Exclusion criteria; 1. Having less than 12 months of enrolment prior to the index date; 2. Dialysis or kidney transplant recipients in baseline period; 3. Having atrial flutter, valvular atrial fibrillation (AF), mechanical valve ; placement, rheumatic AF, mitral valve prolapse/regurge/stenosis in ; baseline period; 4. Having record of deep vein thrombosis or pulmonary embolism < 6 ; months before AF diagnosis in baseline period
• 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

• Study design:
  A non-interventional study based on existing health insurance claims data
• 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
• Setting:
  MDV clinical database between April 2010 and June 2016 was used.
• 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.