DARWIN EU® - Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106394
• EU PAS number:
  EUPAS106052
• Study ID:
  106394
• Official title and acronym:
  DARWIN EU® - Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH)
• DARWIN EU® study:
  Yes
• Study countries:
  Estonia

  France

  Germany

  United Kingdom
• Study description:
  Research question: What is the utilization pattern of endothelin receptor antagonists (ERAs) and phosphodiesterase-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH)? ; ; Study objectives:; Objective 1: To estimate proportions of patients with newly diagnosed pulmonary arterial hypertension (PAH) who initiate treatment with endothelin receptor antagonists (ERAs) or phosphodiesterase-5 inhibitors (PDE-5is), either as monotherapy or in combination, during the period from January 1, 2012, to December 31, 2022. ; Objective 2: To estimate the duration of prescription for ERAs and PDE-5is in patients with newly diagnosed PAH between January 1, 2012, and December 31, 2022.; Objective 3: To describe the prescription patterns and sequences of ERAs and PDE-5is in patients with newly diagnosed PAH between January 1, 2012, and December 31, 2022. ; Objective 4: To estimate the proportion of patients with newly diagnosed PAH who experience specific events of interest, namely: cardiovascular hospitalization, all-cause hospitalization, and death, after initiating treatment with ERAs and PDE-5isPAH between January 1, 2012, and December 31, 2022.
• Study status:
  Finalised

Research institution and networks

Institutions

Clinical Practice Research Datalink (CPRD)

United Kingdom

Real-World-Evidence, IQVIA NL

Netherlands

Bordeaux University Hospital (CHU de Bordeaux)

France

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

United Kingdom

University of Tartu

Estonia

Study timelines

Date when funding contract was signed

Planned: 05/04/2023

Actual: 05/04/2023

Study start date

Planned: 01/01/2012

Actual: 01/01/2012

Date of final study report

Planned: 17/11/2023

Actual: 20/11/2023

Study protocol

Initial protocol

Study Protocol P2 C1-003 Version 2.1 final

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable