在随机对照试验中中止提尔泽帕提德的原因:系统性审查和元分析
Abul Bashar Mohammad Kamrul-Hasan1, Joseph M Pappachan2,3, Deep Dutta4
1Department of Endocrinology, Mymensingh Medical College, Mymensingh 2200, Dhaka, Bangladesh.
World journal of diabetes
|April 16, 2025
概括
蒂尔泽帕提德的中止风险不高于安慰剂,由于某些原因,其风险低于胰岛素和GLP-1RA. 除了不良事件之外,其他因素也会导致终止提泽帕提德治疗.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 临床试验分析
- 药物安全和有效性 药物安全和有效性
背景情况:
- 在临床试验中切断提尔泽帕提德是常见的,通常是由于不良事件 (AE).
- 之前的系统性审查还没有在随机对照试验 (RCT) 中全面分析了蒂尔泽帕提德中止的原因.
研究的目的:
- 在RCT中,系统地分析和比较终止提泽帕提德治疗的原因与对照组 (安慰剂,胰岛素,GLP-1RA) 的原因.
- 为了确定导致提泽帕蒂德治疗停止的具体因素.
主要方法:
- 在主要数据库 (MEDLINE,Scopus,Cochrane,ClinicalTrials.gov) 中,系统地搜索RCT的文献,使用与止皮胺相关的术语,直到2024年6月20日.
- 使用RevMan网络与随机效应模型进行元分析,以计算风险比率 (RR) 和95%置信区间 (CI).
主要成果:
- 分析了17个具有偏差风险较低的RCT (n=14645).
- 与安慰剂相比,提尔泽帕提德10毫克的中止风险明显较低 (RR:0.69).
- 与胰岛素和GLP-1RA相比,停止治疗的风险有所不同,而15毫克蒂尔泽帕提德与胰岛素和10/15毫克蒂尔泽帕提德与GLP-1RA相比风险更高.
- 与AE相关的停药率高于tirzepatide比胰岛素,但低于安慰剂或GLP-1RA对某些剂量.
- 与安慰剂和胰岛素相比,研究对象退出和其他原因显示,提尔泽帕提德的停药风险较低.
结论:
- 蒂尔泽帕提德的中止风险与安慰剂相比较.
- 除了不良事件之外的其他因素在RCT中显著影响提尔泽帕提德治疗的中止.
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