Lithium Versus Anticonvulsants and the Risk of Physical Disorders - Results From a Comprehensive Long-term Nation-wide Population-based Study Emulating a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169,285
- 试验地点
- 1
- 主要终点
- Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
研究概览
简要总结
Nationwide population-based register linkage study covering the entire 5.9 million inhabitants in Denmark systematically investigating the associations between sustained long-term use of lithium versus lamotrigine and valproate, and the risk of a range of physical disorders emulating a randomized trial.
详细描述
The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium, lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of prior diagnosis of bipolar disorder (N= 156.678).
Main analyses considered a patient exposed to a drug 92 days after a prescription and a 10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60 and 180 days after a prescription, respectively, and with 5- and 15-years follow-up, respectively.
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
- 5 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate
排除标准
- 未提供
结局指标
主要结局
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Angina pectoris
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Arteriosclerosis
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Myocardial infarction
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Myxoedema
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Osteoporosis
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Dementia (separately for Alzheimer's disease and other dementia)
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Parkinson's disease
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
时间窗: 1997 to 2021
Diagnosis in the Danish National Hospital Register
次要结局
未报告次要终点