Treatment patterns in patients with pulmonary arterial hypertension

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

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

  TADALAFIL
• Medical condition to be studied:
  Pulmonary arterial hypertension

Population studied

• Short description of the study population:
  The study included patients with a history of pulmonary arterial hypertension (both idiopathic, secondary) identified from the IMRD databases between January 2006 to June 2021.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Pulmonary arterial hypertension patients
• Estimated number of subjects:
  634

Study design details

• Main study objective:
  The main aim of the study was to describe the first line treatment for patients diagnosed with PAH focusing on ERA and PDE5i classes (monotherapy or combined), and describe after how long patients initiating single therapy receive a second drug (combination therapy).
• Data analysis plan:
  A cohort of patients with a history of PAH (both idiopathic, secondary) was created, with follow-up starting at date of diagnosis. Study period was between January 2006 and June 2021 in IQVIA™ Disease Analyser Germany and between 1998 and 2021 in IMRD. Patients with a history of PAH were followed since their first incident prescription of either ERA and PDE5i (incident use) and treatment patterns were reported. The following variables were calculated: • Number of PAH patients • Number of PAH patients that initiated incident treatment with ERA or PDE5i • Treatment initiation patterns over time in PAH patients (overall and specifically for macitentan, tadalafil) • Number of patients initially treated with monotherapy which progressed to combination therapy, (assuming that they stayed on the initial therapy), within 1 year and respectively 2 years since start of treatment.

Documents

Study results

Study Report_Treatment patterns in PAH patients -To be published_CLEAN_final