Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,081
- 试验地点
- 1
- 主要终点
- Delirium occuring when using PPI
研究概览
简要总结
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.
Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delirium mentioned in the safety report
排除标准
- 未提供
研究组 & 干预措施
PPI users
干预措施: PPI (Drug)
结局指标
主要结局
Delirium occuring when using PPI
时间窗: 09/02/2022
次要结局
- Association between PPI use and occurrence of delirium and hyponatremia(09/02/2022)
- Association between PPI use and occurrence of delirium(09/02/2022)
