Pattern of use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation patients in UK general practices

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

  (B01AF01) rivaroxaban

  rivaroxaban

  (B01AF02) apixaban

  apixaban
• Medical condition to be studied:
  Thrombotic stroke

Population studied

• Short description of the study population:
  Among the source population resulting from the combination of THIN and CPRD databases, study will ascertain three separate cohorts of first-time users of rivaroxaban, apixaban and dabigatran using the date of first prescription (index date) of the respective drug (index drug).; This study will apply a new-users (initiators) design. New users are individuals starting a study medication for the first time ever recorded in the database. Yet, they may have used the other study medications before index date and therefore classified as non-naïve. Newusers without any history of any oral anticoagulant would be classified as naïve. All patients aged 18 and above and who have been enrolled in the databases for at least 1 year and had their first prescription recorded in the databases at least 1 year ago will be included in source population. A patient will be considered eligible to enter a study cohort as a first-time user of one the study drugs when he or she has a first prescription of the drug recorded during the enrolment period.; Patients who have any record of being prescribed their index drug prior to the enrolment period or who qualify as members of more than one cohort on the same day, will be excluded. If a patient qualifies as first-time user of more than one study drug during the enrolment period, with different index dates, she/he will be assigned to the cohort of study drug first prescribed during the enrolment period, with the date of this prescription being the index date. (eg mutually exclusive cohorts).; Patients with NVAF defined as:-; Patients with a record of Atrial fibrillation (AF) any time prior index date or within the 2 weeks after the index date, and free of valvular replacement or mitral stenosis prior to index date or 2 weeks after index-date.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 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:
  30000

Study design details

• Main study objective:
  The objective of the study is to characterize first-time users of three DOACs in NVAF patients for stroke prevention including those renal impaired and to assess patterns of drug utilization in routine general practice in the UK
• Outcomes:
  1.Demographic Characteristics2.Risk factor categories3.Previous medical history4.Previous medication history5.Previous use of VKA6.Concurrent co-medication7.Daily dose8.Dose posology9.Naive status and Non-naive status10.Treatment Duration, Time-trends
• Data analysis plan:
  The analysis will be based on descriptive statistics: frequencies and percentages will be calculated to the variables of interests, continuous and count variables will be described using mean (±standard deviation), proportions, median (quartiles) and minimum and maximum values. 95% confidence intercals will be computed for descriptive varaibles.

Documents

Study results

Study 19330_EU PAS Abstract_Redacted_2020-03-20

Study report

Study 19330_EU PASS_Redacted_2020-03-20