Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either UPTRAVI (selexipag) or any other PAH-specific therapy, in clinical practice (EXPOSURE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  UPTRAVI
• Medicinal product name, other:
  UPBRAVI
• Study drug International non-proprietary name (INN) or common name:
  SELEXIPAG
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC27) selexipag

  selexipag
• Medical condition to be studied:
  Pulmonary arterial hypertension

Population studied

• 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)
• Estimated number of subjects:
  3034

Study design details

• Main study objective:
  To describe demographics, disease characteristics and clinical course in PAH patients newly treated with either UPTRAVI, or any other PAH-specific therapy, who were never treated with UPTRAVI, further characterise the safety profile of UPTRAVI in clinical practice, compare rates of MACE and all-cause.
• Outcomes:
  - Outcomes related to PAH clinical course. Occurrence of all-cause death; - Outcomes related to the UPTRAVI safety profile. ; Occurrence of: ; 1. the identified or potential risks ; 2. any other AEs ; 3. Discontinuation of UPTRAVI and reason for stopping; - Outcomes to compare rates of MACE and all-cause death. ; Occurrence of: ; 1. MACE ; 2. all-cause death
• Data analysis plan:
  Exposure to UPTRAVI will be described in terms of duration, maximum dose received in the titration period, maintenance dose and maintenance dose changes in all exposed patients. ; UPTRAVI safety profile will be described with the frequency and incidence rates of important identified and potential risks as described in the Risk Management Plan and all-cause death during the exposure period will be calculated in the UPTRAVI exposed patients. ; MACE and all-cause death incidence rates observed in UPTRAVI exposed patients will be compared with the rates observed in UPTRAVI unexposed patients using a propensity score weighting analysis.