Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  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:
  WARFARIN

  DABIGATRAN
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA03) warfarin

  warfarin

  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients with non-valvular atrial fibrillation at risk for stroke
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrial fibrillation
• Estimated number of subjects:
  9.000

Study design details

• Study design:
  The study uses a cohort design with propensity score matching to address potential confounding.
• Main study objective:
  Quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
• Setting:
  Data for the patients included in this cohort study arose from a de-identified research database of United Healthcare members who had both medical and prescription benefits. The individuals covered by this health insurance are geographically diverse across the United States.
• Outcomes:
  StrokeMajor bleeding, Stroke or systemic embolismSystemic embolismIschemic strokeHemorrhagic strokeStroke uncertain classificationMajor intracranial bleeding Major extracranial bleedingMajor GI bleedingMajor upper GI bleedingMajor lower GI bleedingMajor urogenital bleedingMajor other bleedingTransient ischemic attackMyocardial infarctionVenous thromboembolismDVTPulmonary embolism
• Data analysis plan:
  After identifying initiators of warfarin or dabigatran with an existing diagnosis of non-valvular atrial fibrillation and at risk for stroke in a large US commercial claims database we will use propensity score methods and time-to-event analyses to estimate the ratio in hazard rates for each of the outcomes of interest.