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

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

H. Lundbeck

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Networks

The SIGMA Consortium (SIGMA)

Denmark

European Union

France

Germany

Italy

Netherlands

Norway

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:30/11/2025

Actual:30/01/2026

Study start date

Planned:01/05/2026

Data analysis start date

Planned:10/01/2030

Date of interim report, if expected

Planned:30/06/2028

Date of final study report

Planned:31/12/2030

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)