Long-term cardiovascular safety and real-world use of eptinezumab - An observational, historical cohort study of patients initiating eptinezumab in routine clinical practice

28/01/2026
28/01/2026
EU PAS number:
EUPAS1000000882
Study
Planned
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Study identification

EU PAS number

EUPAS1000000882

Study ID

1000000882

Official title and acronym

Long-term cardiovascular safety and real-world use of eptinezumab - An observational, historical cohort study of patients initiating eptinezumab in routine clinical practice

DARWIN EU® study

No

Study countries

Denmark
Germany
Italy
United States

Study description

This post-authorisation safety study (PASS) will be conducted using longitudinal healthcare databases. It uses a historical comparative cohort study design and will include migraine patients treated with eptinezumab in routine clinical practice and followed-up for a maximum of six years from exposure start. In addition, control cohorts of migraine patients without exposure to eptinezumab will be identified. Major adverse cardiovascular events (MACE), defined as nonfatal stroke, nonfatal acute coronary syndrome, or cardiovascular death, will be the primary study outcome. The risk of MACE in patients treated with eptinezumab will be compared with the risk in control cohorts of patients with migraine who were not treated with eptinezumab. All analyses will be performed separately in each included healthcare databases. The risk estimates from the individual healthcare databases will then be pooled in meta-analyses to increase statistical power of the final combined analysis.

Study status

Planned
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
H. Lundbeck
First published:
01/02/2024
Institution

Contact details

Non-interventional Research Manager H. Lundbeck A/S - Observational Research Committee commres1742@lundbeck.com

Study contact
commres1742@lundbeck.com

H. Lundbeck A/S Non-interventional Research Manager

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

H. Lundbeck A/S
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)