Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Descriptive analysis of the studied population
研究概览
简要总结
The incidence of fall in older adults aged 65 and over is estimated at 30%, and 50% of the people aged 80 and over with at least one fall a year. Falls are associated with significant morbidity and mortality.
The origin falls is often multifactorial, involving intrinsic and extrinsic factors. Few studies have investigated the association with all antidepressants. Potential adverse effects of antidepressants such as hyponatremia, sedation, orthostatic hypotension, extrapyramidal symptoms are known risk factors for falls. Due to multimorbidity, polypharmacy including interaction risks, and aging-related changes in pharmacokinetic and pharmacodynamic of drugs, antidepressants may further increase this risk in older patients.
Based on the World Health Organization global database, the main objective of this study is to investigate the association between antidepressants classes and the occurrence of falls reported in the database.
A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of falls.
A mediation analysis will also be performed. It will aim to examine some of the mediators involved in the association between antidepressants classes and falls.
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
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be over 65 years old
- •take antidepressants
- •have already presented falls
排除标准
- 未提供
结局指标
主要结局
Descriptive analysis of the studied population
时间窗: 01/07/2022
The investigators describe the profile of patients who are reported in the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, as having experienced a fall. In particular, the number of patients who use antidepressants (Non-selective monoamine reuptake inhibitors, Selective serotonin reuptake inhibitors, Selective serotonin-norepinephrine reuptake inhibitors, Alpha-2-adrenergic receptor antagonists, Monoamine oxidase inhibitors, other antidepressants), the number of patients who presented associated illnesses known to induce falls, the number of patients who presented associated drug prescriptions known to induce falls.
Analysis of the association between antidepressant classes and falls reporting, among subjects aged 65 or older
时间窗: 01/07/2022
A disproportionality analysis is carried out in multivariate analysis, taking into account some confounding factors (potentially associated illnesses and prescriptions known to induce falls)
次要结局
- Analysis of the most frequent antidepressants(01/07/2022)
- Mediation analysis(01/07/2022)
- Analysis by age group(01/07/2022)