Domperidone Use in Parkinson's Disease and Risk of Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214,962
- 试验地点
- 1
- 主要终点
- Ventricular tachyarrhythmia (VT) or sudden cardiac death (SCD)
研究概览
简要总结
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.
详细描述
The purpose of this study is to assess the risk of serious cardiac events associated with the use of domperidone in a cohort of patients with Parkinson's disease. More specifically, the study objective is to assess the risk of ventricular tachyarrhythmia and sudden cardiac death associated with the use of domperidone compared to no use in patients with Parkinson's disease. In addition, the investigators would also like to determine whether the risk of ventricular arrhythmia and sudden cardiac death increases with the dose of domperidone in patients with Parkinson's disease.
The investigators will use a common-protocol approach to conduct retrospective cohort studies using health care data from eight jurisdictions (the Canadian provinces of Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan, as well as the United Kingdom (UK) Clinical Practice Research Datalink [CPRD]). The Canadian databases contain population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, vital statistics, and dispensations for prescription drugs. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK; these data will be linked to the Hospital Episode Statistics (HES) database, which contains in-hospital diagnosis and procedure data.
Study Population
In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new diagnosis of Parkinson's disease or a first-ever prescription of an antiparkinsonian drug between January 1, 1990 (or 1 year after site-specific data is available, whichever is later) and June 30, 2012. Patients will be followed from the date of study cohort entry until the occurrence of either study endpoint (defined below) or censoring due to death, departure from the database, loss of continuous health plan or drug plan enrolment, entry into a long-term care facility, or the end of the study period (or the last date of data availability at that site), whichever occurs first. Data from Alberta, Ontario, and Nova Scotia will be restricted to patients aged 66 years and older as prescription data are not available for younger patients.
Case-control selection
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Treated with domperidone
Patients who received a new prescription for domperidone (ATC A03FA03) in the year prior to the index date.
干预措施: Domperidone (Drug)
结局指标
主要结局
Ventricular tachyarrhythmia (VT) or sudden cardiac death (SCD)
时间窗: 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.
次要结局
未报告次要终点