Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia

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:
  All patients aged ≥18 years with a diagnosis of Non valvular Atrial Fibrillation (NVAF) and with at least 1 year of enrollment with their primary care physician (PCP) in the Audifarma S.A database and with 1 year since their first recorded health contact r were eligible for inclusion. Three mutually exclusive cohorts of first-time users of a Non-vitamin K antagonist Oral Anticoagulants (NOAC) (rivaroxaban, apixaban or dabigatran) with the date of first prescription the NOAC (index drug) being the index date, and followed all patients for at least 1 year. ; Inclusion Criteria; 1. First prescription of NOACs (rivaroxaban, dabigatran and apixaban) in the outpatient setting.; 2. NVAF Patients; 3. aged ≥18 years; 4. at least one year of enrollment in the Audifarma database; 5. one year since first encounter with healthcare provider will be included in the study. ; ; Exclusion criteria; 1. Patients with any record of index drug prescription prior to the enrolment period.; 2. Patients who qualify as members of more than one cohort study on the same day.
• 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:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  This population-based descriptive study will characterize first-time users of three non-vitamin k antagonists oral anticoagulants (rivaroxaban, dabigatran and apixaban) in non-valvular atrial fibrillation patients and will assess the patterns of drug utilization in routine general practice in Colombia.
• Outcomes:
  • Baseline patient characteristics of SPAF patients in Colombia prescribed any of the three NOACs (rivaroxaban, dabigatran and apixaban) for the first time for stroke prevention• Outpatient patterns (daily dose, dose posology, naïve status and treatment duration) of rivaroxaban, dabigatran and apixaban use in SPAF patients, • Time-trends in the characteristics of first-time use of NOACs in SPAF patients. The primary endpoints like patient characteristics, medical history, medication history, characteristics of index prescription, stratified per year (wherever possible).
• 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 intervals will be computed for descriptive variables.