Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 主要终点
- Acute kidney injury
研究概览
简要总结
Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.
详细描述
Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent.
Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of a gout diagnosis
- •Initially receiving at least one anti-gout drug
排除标准
- •<1 year of continuous health insurance enrollment
- •Colchicine and NSAID use before the cohort entry date
- •Patients with hemodialysis or peritoneal dialysis before the cohort entry date
- •Patients with acute kidney injury before the cohort entry date
研究组 & 干预措施
Case
Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury.
干预措施: Colchicine and NSAID (Drug)
Control
Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury.
干预措施: Colchicine and NSAID (Drug)
结局指标
主要结局
Acute kidney injury
时间窗: Through study completion, an average of 1 year
Number of participants with a diagnosis of acute kidney injury
次要结局
- Hemodialysis or peritoneal dialysis(Through study completion, an average of 1 year)
- All cause mortality(Through study completion, an average of 1 year)
研究者
Ya-Ling Huang
Principal Investigator
En Chu Kong Hospital