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

IQVIA
France
United Kingdom
First published:
22/03/2024
Institution
Non-Pharmaceutical company
ENCePP partner
University of Tartu
Estonia
First published:
01/02/2024
Institution
Educational Institution
University of Oxford – CPRD data United Kingdom, IQVIA DA Germany Germany, CHUBX France France, University of Tartu - Estonian Biobank Estonia

Networks

Contact details

Johnmary Arinze

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol
English (1.5 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable