Clinical and Economic Outcomes and Treatment Patterns for Non-Valvular Atrial Fibrillation Patients Who Newly Initiated Oral Anticoagulants in the US Medicare Population

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Longitudinal retrospective cohort analysis using the US FFS Medicare database

Study drug and medical condition

• Name of medicine:
  ELIQUIS
• Medical condition to be studied:
  Atrial fibrillation

  Venous thrombosis

Population studied

• Short description of the study population:
  Non-valvular atrial fibrillation (NVAF) patients prescribed an oral anticoagulants (OAC) between 01-Jan-2013 to 31-Dec-2015 (or most recent data available) with continuous health plan enrollment during their baseline period were included in the study. The first Several direct oral anticoagulants (DOAC) pharmacy claim date during the identification period was designated as the index date. The first warfarin prescription date was designated as the index date for patients without any DOAC claim. For the annual prevalence calculation, NVAF patients aged ≥65 years with continuous enrollment during each year from 2012 to 2015 were included as the numerator. The Medicare population aged ≥65 years with continuous enrollment during each year from 2012 to 2015 was included as the denominator.
• Age groups:
  • Adult and elderly population (≥18 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:
  1

Study design details

• Main study objective:
  1. Compare the risk of stroke/SE and major bleeding between NVAF patients who initiated OACs (warfarin, apixaban, rivaroxaban, dabigatran, or edoxaban).2. Compare all-cause and stroke/SE- and major-bleeding-related health care costs among NVAF patients who initiated OACs.3. Compare treatment patterns (discontinuation, switch, and dose) among the cohorts.
• Outcomes:
  Stroke/SE, Composite clinical outcomes, MB and related cost outcomes
• Data analysis plan:
  Descriptives, PSM, Cox Proportional