Assessment of the Dose Reduction and Discontinuation Associated With Anti-Fibrotic Medications in Patients With Idiopathic Pulmonary Fibrosis

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:
  Cohort

Study drug and medical condition

• Medicinal product name:
  OFEV

  ESBRIET
• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB

  PIRFENIDONE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX05) pirfenidone

  pirfenidone

Population studied

• Short description of the study population:
  Patients with Idiopathic Pulmonary Fibrosis

Study design details

• Study design:
  Non-interventional, retrospective cohort study
• Main study objective:
  1. Primary aim -To assess average daily dose, and corresponding dose reduction/interruption patterns in nintedanib and pirfenidone initiators separately at 6-and 12-months post initiation. ; 2. Secondary aim -To assess drug discontinuation patterns in nintedanib and pirfenidone initiators separately at 6-and 12 months post-initiation.
• Outcomes:
  The main outcomes for the study were incidence of sub-optimal dosing and discontinuation, calculated separately for pirfenidone and nintedanib. For each patient, average daily dose was calculated separately in each month in; the post-index period.