Study identification

PURI

https://redirect.ema.europa.eu/resource/49013

EU PAS number

EUPAS21574

Study ID

49013

Official title and acronym

Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists

DARWIN EU® study

No

Study countries

Denmark

Study description

Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist (LABA), for the indication of chronic obstructive pulmonary disease (COPD). In the Decentralised Procedure for Striverdi Respimat, the health authorities of the European Union/European Economic Area Member States requested the conduct of a post-authorisation safety study (PASS) to gather additional data on safety in long-term use of olodaterol. The PASS will include evaluation of users of olodaterol monotherapy as well as in fixed-dose combination with tiotropium. The results of this study will provide insight into the absolute and relative frequency of cardiac arrhythmias and myocardial ischaemia events of interest in comparison to alternative LABA therapies for COPD. Primary study objectives are to: (1) examine the risk of selected cardiac arrhythmias in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs, and (2) examine the risk of acute myocardial infarction (AMI) and other serious ischaemic heart disease events, including unstable angina, in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs. The secondary objective is to examine the risk of overall mortality in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs. The study population will consist of patients with COPD aged 40 years or older in Denmark, a country where olodaterol is available and where a large proportion of the population is included in health care databases used for pharmacoepidemiologic research. Patients will be new users of olodaterol or other LABA, with no dispensing of any LABA in the 6 months before the first prescription of olodaterol or LABA during the study period (index date) and at least 1 year of enrolment in the database.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Cristina Rebordosa

Primary lead investigator
ORCID number:
0000-0002-8064-5997
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH
Study protocol
Initial protocol

1222-0054--protocol_redacted

English (667.53 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 2 (specific obligation of marketing authorisation)