The Comparative Safety and Effectiveness of dabigatran, versus rivaroxaban, and apixaban Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation Patient Population-A Retrospective Database Analysis

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness 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

  RIVAROXABAN

  APIXABAN
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients diagnosed with non valvular atrial fibrillation (NVAF) with newly initiated dabigatran or rivaroxaban or apixaban.
• 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:
  Patients with atrial fibrillation
• Estimated number of subjects:
  47000

Study design details

• Main study objective:
  To assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with NVAF in comparison to newly initiated rivaroxaban users and newly initiated apixaban users in two (2) separate study cohorts:• dabigatran vs. rivaroxaban • dabigatran vs. apixaban
• Outcomes:
  • Stroke overall (hemorrhagic, ischemic, uncertain)• Major bleeding, overall, Secondary outcomes• Ischemic stroke• Hemorrhagic stroke• Major intracranial bleeding• Major extracranial bleedingo Major GI bleedingo Major other bleeding• TIA• All-cause mortality
• Data analysis plan:
  The target population will include OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban or apixaban. For each patient treated with a NOAC, the date of the first NOAC prescription (index exposure) will serve as the index date. Only those patients whose index date occurs between the respective study periods will be included. The 12-month period prior to the index date will be defined as the pre-index period. The patients will be required to have a NVAF diagnosis in the pre-index period (including index date).