Clinical trial

Domperidone Use in Parkinson's Disease and Risk of Sudden Cardiac Death

Name

Q13-02

Description

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.

Trial arms

Trial start

2013-05-01

Estimated PCD

2015-06-01

Trial end

2015-06-01

Status

Completed

Treatment

Domperidone

Current exposure to domperidone will be defined as a prescription dispensed within 30 days before the index date. Recent exposure to domperidone will be defined as a prescription dispensed between 31 and 90 days before the index date (without a dispensing during the 30 days period preceding index date). Past exposure to domperidone will be defined as a prescription dispensed between 91 and 365 days before the index date (without prescription in the 90 days period prior index date).

Arms:

Treated with domperidone

Size

214962

Primary endpoint

Ventricular tachyarrhythmia (VT) or sudden cardiac death (SCD)

Patients will be followed from the date of study cohort entry until the occurrence of VT or SCD, censoring, or for up to 16 years.

Eligibility criteria

Inclusion Criteria: Patients with a diagnosis of Parkinson's disease or a prescription for an antiparkinsonian drug, with at least 365 days of information in the database prior to cohort entry. Exclusion Criteria: * Age \< 50 on the cohort entry date; or age \< 66 in databases with seniors only * Missing gender * Less than 1 year of provincial Medicare enrollment and equivalent enrollment in the CPRD preceding cohort entry * Patients in a long term care facility * Diagnosis of PD or dispensing (prescription in CPRD) of an antiparkinsonian drug in the year preceding cohort entry * Patients with a prescription for an antiparkinsonian drug without a diagnosis of Parkinson's disease but with another indication such as atypical Parkinsonism or secondary Parkinsonism, restless legs syndrome, hyperprolactinemia, or acromegaly in the year before cohort entry * All patients with a prescription for domperidone in the year before cohort entry * All patients with a history of ventricular tachyarrhythmia, aborted cardiac arrest, implantation of a cardiac defibrillator, cancer other than non-melanoma skin cancer * Cohort entry date same as cohort exit date (no follow-up)

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 214962, 'type': 'ACTUAL'}}

Updated at

2024-02-09

1 organization

1 product

1 indication

Organization

Canadian Network for Observational Drug Effect Studies

Product

Domperidone

Indication

Parkinson's Disease