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).