Adherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants (QD versus BID DOACs)

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:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AF) Direct factor Xa inhibitors

  Direct factor Xa inhibitors
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients using direct oral anticoagulants (DOACs) for the treatment of Atrial fibrillation (AF).
• 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:
  Atrial fibrillation patients
• Estimated number of subjects:
  130000

Study design details

• Main study objective:
  The primary objectives of this study are to:• determine the relationship between adherence and QD vs. BID• determine the relationship between persistence and QD vs. BID• determine the relationship between adherence and switchers vs. non-switchers• determine the relationship between persistence and switchers vs. non-switchers• compare switching patterns for QD and BID
• Outcomes:
  Adherence and persistence
• Data analysis plan:
  Adherence to treatment will be defined based on the proportion of days covered (PDC) during the exposure period. Persistence with treatment will be defined as the time from index date to treatment discontinuation and will be based on DOAC treatment episodes.Switching patterns will be assessed from the day after index date until the end of follow-up based on DOAC treatment episodes. This will be defined as either the occurrence of a dosage regimen switch or a BID/QD cluster switch (i.e. to another DOAC with the same dosage regimen).