Overview

Domperidone and Risk of Sudden Cardiac Death

Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the risk of serious cardiac events, specifically ventricular tachyarrhythmia and sudden cardiac death (VT/SCD), associated with the use of domperidone in a population of patients with Parkinson's disease. The hypothesis for this study is that the risk of VT/SCD will be higher among domperidone users, especially at a higher dose. The investigators will conduct a retrospective population-based cohort study using health care databases in eight jurisdictions in Canada and the UK. The study cohort will be defined by the initiation of a new antiparkinsonian drug or a new diagnosis of Parkinson's disease. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of VT/SCD in users of domperidone.
Details
Lead Sponsor:
Canadian Network for Observational Drug Effect Studies, CNODES
Collaborators:
Canadian Institutes of Health Research (CIHR)
Drug Safety and Effectiveness Network, Canada
Treatments:
Domperidone