Domperidone and Risk of Sudden Cardiac Death
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|ClinicalTrials.gov Identifier: NCT02500108|
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : April 19, 2016
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.
|Condition or disease||Intervention/treatment|
|Parkinson's Disease||Drug: Domperidone|
|Study Type :||Observational|
|Actual Enrollment :||214962 participants|
|Official Title:||Domperidone Use in Parkinson's Disease and Risk of Sudden Cardiac Death|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Treated with domperidone
Patients who received a new prescription for domperidone (ATC A03FA03) in the year prior to the index date.
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).
Unexposed (reference) group
Patients with no prescription for domperidone in the year prior to the index date.
- Ventricular tachyarrhythmia (VT) or sudden cardiac death (SCD) [ Time Frame: 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. ]
VT/SCD will be defined as patients with one of the following diagnostic codes:
VT: ICD-9 codes 427.1, 427.4; ICD-10 codes I47.0, I47.2, I49.0. SCD/ cardiac arrest: ICD-9 codes: V12.53, 427.5, 798.1, 798.2, 798.9; ICD-10 codes: Z86.74, I46.0, I46.1, I46.9, R96.0, R96.1, R98.
All potential cases will be subjected to a computer algorithm to exclude non-relevant events (such as events due to non-arrhythmic cardiac causes or acute life-threatening non-cardiac causes); all potential cases that are not excluded by the algorithm will be reviewed in each centre to exclude cases that do not meet the inclusion and exclusion criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500108
|Lady Davis Institute for Medical Research, Jewish General Hospital|
|Montreal, Quebec, Canada, H3T1E2|
|Principal Investigator:||Christel Renoux, MD, PhD||Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University|