Study identification

EU PAS number

EUPAS18129

Study ID

36375

Official title and acronym

Serious Liver Injury and Interstitial Lung Disease Occurrences in Patients Diagnosed with Atrial Fibrillation Treated with Selected Antiarrhythmics

DARWIN EU® study

No

Study countries

United States

Study description

Prospective population monitoring will be employed to conduct the surveillance portion of the program and an observational retrospective cohort study will be conducted to compare rates of serious Liver injury/disease and interstitial lung disease, separately, in patients exposed to other selected anti-arrhythmic comparator cohorts versus dronedarone-exposed patients. Two administrative claims databases (OptumInsight formerly i3 Drug Safety/United Health Care and HealthCore/WellPoint) and one electronic health record (EHR) system (Health ResearchTx/Department of Defense, or DoD) will be used to monitor the use of dronedarone in the general population and The HealthCore Integrated Research Database (or HIRD) and the DoD databases will be used for the retrospective study. Retrospective and prospective population monitoring of defined exposures and outcomes will commence in each database as of July 20, 2009 (dronedarone launch date). Monitoring will continue through 2015 or until a sufficient number of dronedarone users are identified for the initiation of a targeted pharmacoepidemiology study. The study population will be comprised of patients treated for atrial fibrillation or flutter (AF/AFL) who are treated with anti-arrhythmic drugs (dronedarone, amiodarone, sotalol, flecainide, dofetilide, and propafenone). In addition to prospectively capturing the number of new users of dronedarone and comparator drugs, the surveillance component of this study will capture the number of serious liver injury and interstitial lung disease occurrences after the index date in the study population.

Study status

Finalised
Research institutions and networks

Institutions

Sanofi
First published:
01/02/2024
Institution

Contact details

Trial Transparency Team

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

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

More details on funding

Sanofi U.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)