DARWIN EU® - Sex differences in treatment patterns for venous thromboembolic events in European countries

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Anticoagulants (ATC code B01)
• Anatomical Therapeutic Chemical (ATC) code:
  (B01) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS
• Medical condition to be studied:
  Venous thrombosis

Population studied

• Short description of the study population:
  Objective 1 (Characterisation of first-line anticoagulant treatment); Inclusion criterion: Diagnosis of VTE during the recruitment period; Exclusion criteria; • Age <18 years at first VTE event (index date); • Less than 365 days of available history before the index date; • Record of VTE event before study start (01/01/2015); • Record of prescription/dispensation of anticoagulants before the index date; Objectives 2 and 3 (Drug utilisation of first-line treatment and switching patterns); Inclusion criteria; • Diagnosis of VTE during the recruitment period; • Initiation of anticoagulant drug treatment within 90 days after diagnosis (index date); Exclusion criteria; • Age <18 years on the date of anticoagulants treatment initiation; • Less than 365 days of available history before date of anticoagulants treatment initiation ; • Record of VTE before study start 01/01/2015; • Record of anticoagulant drug prescription/dispensation before diagnosis of first VTE event;
• 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)

Study design details

• Study design:
  A (new user) cohort study will be conducted using routinely collected health data from 5 data sources from 5 countries across Europe and in 4 European Union (EU) member states
• Main study objective:
  1. To describe anticoagulant treatment initiation for venous thromboembolic events in males and females; 2. To describe drug utilisation of anticoagulant treatments, including initial treatment duration and initial dose, in males and females; 3. To describe and compare anticoagulant treatment switching and combination patterns for venous thromboembolic events in males and females