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

Completed

• Conditions: Atrial Fibrillation; Anticoagulants; Pharmacoepidemiology
• Interventions: Drug: Dabigatran

• Registration Number: NCT02904499
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2016-09
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 814446

Inclusion Criteria

• Patients with non-valvular atrial fibrillation
• Patients receiving an first prescription of anticoagulants

Exclusion Criteria

• Patients with valvular atrial fibrillation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dabigatran	Dabigatran	First Initiators of Dabigatran for non-valvular atrial fibrilation

Primary Outcome Measures

Name	Time	Method
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	36 months	Propensity-matching is required for adequate comparison and multivariate regression

Trial Locations

Locations (1)

University Hospital of Reunion Island; 🇫🇷 Saint Denis, Reunion Island, France