DARWIN EU® - Sex-specific incidence of selected adverse events for major cardio-metabolic drug classes

11/08/2026
25/08/2026
EU PAS number:
EUPAS1000001081
Study
Ongoing
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Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000001081

Study ID

1000001081

Official title and acronym

DARWIN EU® - Sex-specific incidence of selected adverse events for major cardio-metabolic drug classes

DARWIN EU® study

No

Study countries

Belgium
Finland
Germany
Netherlands
Spain
United Kingdom

Study description

Although cardiovascular disease (CVD) is a leading cause of death in females, it is still often regarded as mainly affecting males. Females remain underdiagnosed, undertreated, and underrepresented in clinical trials, leading to treatment guidelines being based mainly on evidence from male populations. However, sex differences in drug responses can affect both treatment efficacy and the risk of adverse effects, highlighting the need for more sex-specific evidence

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Xinting Li

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable