Association between use of direct oral anticoagulants (DOACs) and increased risk of interstitial lung disease

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  No individual level data collected for the purpose of the study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  DOACs and vitamin-k antagonists
• Study drug International non-proprietary name (INN) or common name:
  APIXABAN

  DABIGATRAN

  EDOXABAN

  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  (B01) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS

  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AF01) rivaroxaban

  rivaroxaban

  (B01AF02) apixaban

  apixaban
• Medical condition to be studied:
  Interstitial lung disease

Population studied

• Short description of the study population:
  People with atrial fibrillation; People with venous thromboembolism
• 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:
  New user active comparator cohort study
• Main study objective:
  Assess whether use of factor Xa (FXa) inhibitors (edoxaban, apixaban and rivaroxaban) or direct thrombin inhibitor (dabigatran) associated with an increased risk of interstitial lung disease (ILD) when compared with patients treated with vitamin K antagonists (VKA), among patients with Atrial Fibrillation (AF), Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
• Setting:
  Primary care data sources
• Comparators:
  Vitamin-K antagonists
• Outcomes:
  Interstitial lung disease (ILD)
• Data analysis plan:
  Propensity score matched cohort study with use of propensity score diagnostics to assess adequate confounding control. ; Use of Cox regression to estimate hazard ratios for incident ILD among the target cohort (DOAC users) and control cohort (VKA users).