Evaluation of potential off-label use of dabigatran etexilate in Europe

Study type

• Study topic:
  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:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE

Population studied

• Short description of the study population:
  Patients who received a new prescription of dabigatran etexilate in the study period and have at least 1 year of enrolment in the electronic database and have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  Renal impaired
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  Estimate the proportion of off-label use in new users of dabigatran according to the recorded clinical indication or generated proxies as available in each DB.Describe the characteristics of new users of dabigatran including dose, demographics, clinical indication, morbidity and use of other medications prior to the first captured prescription, stratified by usage sub-group—on- or off-label use.
• Outcomes:
  The main outcome of this study is the proportion of off-label use estimated among new users of dabigatran etexilate, new users will be characterised.
• Data analysis plan:
  The analyses will be descriptive at baseline. The main analysis will be to estimate (with 95% confidence intervals) the prevalence proportion of off-label use among new users of dabigatran etexilate during the overall study period in each of the study populations. All the results will be presented for each country-specific database. A weighted, pooled prevalence of off-label use among new users of dabigatran etexilate for the entire study population (study populations of the CPRD, Cegedim, and Danish national databases combined) will be estimated (with 95% confidence intervals) when the individual results of all three databases are available.