Atrial Fibrillation Clinical Trial
Official title:
Use of Public Health Surveillance Models in the French National Health System Database: A Tool for an Ongoing Monitoring of Adverse Drug Reaction? The Case of Dabigatran
Public health surveillance models, previously used for the ongoing detection of occurrence of
rare events, could be used to reinforce existing pharmacovigilance systems. These models have
not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative
databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran,
launched recently on the French market for atrial fibrillation (AF). This drug is at high
risk for severe ADR and requires thus careful pharmacovigilance monitoring.
Primary objective is to compare the results of ongoing surveillance models to detect
hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results
obtained from the analysis of a cohort of patients with AF under the same treatment.
DABISURV study consists in an analyze of a cohort of patients with AF who have received at
least one prescription Vitamin K Antagonists (VKA) - reference group - or of dabigatran in
the French National Health Insurance System.
The uptake of dabigatran is followed for detecting hemorrhagic events or AMI associated with
this molecule among first users.
The ability to detect quickly substantial ADR of new drugs is of critical importance to
public health in order to facilitate timely public health response. If the public health
surveillance models are found useful for this topic, then semi-automated procedures would be
needed to detect ADR associated with new generation anticoagulants in medico-administrative
databases. If the public health surveillance models are found not useful for the detection of
ADR, the cohort study itself will provide essential data on the safety profile of dabigatran.
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