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Domperidone and Risk of Sudden Cardiac Death

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500108
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Network for Observational Drug Effect Studies, CNODES

Brief 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.


Condition or disease Intervention/treatment
Parkinson's Disease Drug: Domperidone

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Study Type : Observational
Actual Enrollment : 214962 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Group/Cohort Intervention/treatment
Treated with domperidone
Patients who received a new prescription for domperidone (ATC A03FA03) in the year prior to the index date.
Drug: 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).


Unexposed (reference) group
Patients with no prescription for domperidone in the year prior to the index date.



Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of all subjects with a diagnosis of Parkinson's disease or a prescription for an antiparkinsonian drug who were registered for provincial medical services coverage or registered in a clinical practice (CPRD) at any time between January 1, 1990 (or 1 year after site-specific data is available, whichever is later) and June 30, 2012.
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)

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Christel Renoux, MD, PhD Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
Additional Information:
Publications of Results:
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Responsible Party: Canadian Network for Observational Drug Effect Studies, CNODES
ClinicalTrials.gov Identifier: NCT02500108    
Other Study ID Numbers: Q13-02
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Canadian Network for Observational Drug Effect Studies, CNODES:
Domperidone
Ventricular Tachyarrhythmia
Sudden cardiac death
Pharmacotherapy
Adverse events
Additional relevant MeSH terms:
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Parkinson Disease
Death, Sudden, Cardiac
Death
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action