A description of warfarin and new oral anticoagulant utilization patterns including initiation, switching, and discontinuation: Phase 3 of the BI/BWH Pradaxa study program (Anticoagulant utilization pattern)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01A) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients ≥18 years with a diagnosis of Non-valvular atrial fibrillation (NVAF) at risk for stroke (CHA2DS2-VASc score ≥ 1) who initiated treatment either with warfarin, dabigatran, rivaroxaban or apixaban between January 2009 and September 2015.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  Provide a description of patients with non-valvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for new oral anticoagulant medications as they become available.
• Outcomes:
  Proportion of patients dispensed specific anticoagulants and anticoagulant doses (for new oral anticoagulant medications)Description of the characteristics of patients with non-valvular atrial fibrillation initiating oral anticoagulants, Treatment persistence over time
• Data analysis plan:
  Analyses are descriptive. Utilization patterns will be examined overall and in subgroups defined by patient characteristics, incident/former use, and over time. The initial analyses will be based on January 2009- June 2012 data and will be updated at 6-month intervals as more data become available through 2015.