Study identification

PURI

https://redirect.ema.europa.eu/resource/15148

EU PAS number

EUPAS1591

Study ID

15148

Official title and acronym

Cardiac profile of patients using rosiglitazone-containing anti-diabetes medicines: a study using the THIN database

DARWIN EU® study

No

Study countries

United Kingdom

Study description

The study is a retrospective analysis of a cohort of patients prescribed rosiglitazone based on the UK GP database, THIN. It suggests that about 8% of patients take rosiglitazone despite having cardiac contraindications as defined by the current SPC – congestive heart failure or acute coronary syndrome.

Study status

Finalised
Research institution and networks

Institutions

European Medicines Agency

Contact details

Jim Slattery

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Date of final study report

Actual:
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