DARWIN EU® CC - 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® CC - 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:
  Ongoing

Research institution and networks

Institutions

Clinical Practice Research Datalink (CPRD)

United Kingdom

IQVIA

United Kingdom

Bordeaux University Hospital (CHU de Bordeaux)

France

University of Tartu

Estonia

University of Oxford – CPRD data United Kingdom, IQVIA DA Germany Germany, CHUBX France France, University of Tartu - Estonian Biobank Estonia

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Hungary

Netherlands

Norway

Portugal

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 04/05/2023

Actual: 04/05/2023

Study start date

Planned: 01/01/2012

Actual: 01/01/2012

Date of final study report

Planned: 30/11/2023

Sources of funding

EMA

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