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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36375
• 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

Study timelines

Date when funding contract was signed

Planned: 08/01/2011

Actual: 08/01/2011

Study start date

Planned: 15/08/2011

Actual: 15/08/2011

Data analysis start date

Actual: 15/08/2011

Date of final study report

Planned: 30/06/2017

Actual: 09/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi U.S.

Study protocol

Initial protocol

DRONEC05917 protocol

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)

Other study registration identification numbers and links

DRONE_C_05917