Use of Public Health Surveillance Models in the French National Health System Database

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology

Intervention / Treatment
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* Drug: Dabigatran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-valvular atrial fibrillation Patients receiving an first prescription of anticoagulants Exclusion Criteria: Patients with valvular atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VKA<br>First Initiators of VKA for non-valvular atrial fibrilation | |
| Dabigatran<br>First Initiators of Dabigatran for non-valvular atrial fibrilation | Drug: Dabigatran<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| results of ongoing surveillance models to detect hemorrhages or AMI (in frequency and proportion) associated with dabigatran or VKA for AF in a health database cohort of patients with AF treated by dabigatran or VKA | Propensity-matching is required for adequate comparison and multivariate regression | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology