Use of Public Health Surveillance Models in the French National Health System Database
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
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.