Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,608
- 主要终点
- The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)
研究概览
简要总结
The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are the Saskatchewan residents who used domperidone or another type of medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be collected from various sources including the Saskatchewan Health (SH) database and Cancer Registry.
详细描述
The purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (a medication used to treat certain gastrointestinal disorders) compared with users of proton pump inhibitors (another group of medications used to reduce gastric or stomach acid production. The study will be conducted using patient information from Saskatchewan Health (SH) who had recorded dispensings of domperidone or a PPI from 1990 through 2005. The first objective of the study is to estimate the combined relative risk of the occurrence of a particular type of irregular heart rhythm known as serious ventricular arrhythmia (SVA) and sudden cardiac death SCD (defined as a natural death from an unexpected circulatory arrest) during current use of domperidone or current use of proton pump inhibitors (PPIs) as compared with nonuse in a diabetic population. The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population. Study drug dosing information not required for Observational Study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005
排除标准
- •Cancer free >=1 year of history in the database before receiving the first dose of domperidone or a PPI
研究组 & 干预措施
001
Current Domperidone Current domperidone at any dose regardless of proton pump inhibitor status
干预措施: Current Domperidone (Drug)
002
Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine
干预措施: Current proton pump inhibitor (PPI) (Drug)
003
No Intervention Neither current domperidone nor current PPI
干预措施: No Intervention (Other)
结局指标
主要结局
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)
时间窗: Retrospective study
次要结局
- The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population.(Retrospective)