A Novel Composite Endpoint to Evaluate the Gastrointestinal (GI) Effects of Nonsteroidal Antiinflammatory Drugs Through the Entire GI Tract
A Novel Composite Endpoint to Evaluate the Gastrointestinal (GI) Effects of Nonsteroidal Antiinflammatory Drugs Through the Entire GI Tract
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DOI：
10.3899/jrheum.090168
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发表时间：
2010-01-01
影响因子：
3.9
通讯作者：
Dodge, William
中科院分区：
文献类型：
--
作者：
Chan, Francis K. L.;Cryer, Byron;Dodge, William
客观的。非甾体类抗炎药（NSAID）不仅会对上消化道（GI）造成损害，还会影响下消化道。迄今为止，还没有评估整个胃肠道严重胃肠道事件的终点。本报告的目的是介绍一种新的复合终点，用于测量非甾体抗炎药引起的胃肠道损伤患者的整个胃肠道损伤——临床上显着的上消化道和下消化道事件（CSULGIE）。方法。我们回顾了与 NSAID 使用相关的较低胃肠道毒性的大规模、多中心、随机临床试验的数据。还讨论了在两项正在进行的试验中使用 CSULGIE 作为主要终点的基本原理，即塞来考昔与奥美拉唑和双氯芬酸治疗高危骨关节炎 (OA) 和类风湿关节炎 (RA) 患者 (CONDOR) 试验以及胃肠道随机事件和安全性开放标签 NSAID 研究 (GI-REASONS)。结果。之前的随机试验主要关注上消化道的损伤，常常忽视下消化道的损伤。 CSULGIE 终点扩展了上消化道并发症的传统“穿孔、梗阻和出血”评估，包括下消化道（小/大肠）的事件，例如穿孔、出血和临床显着贫血。结论。通过为临床医生提供一种新的描述性语言来描述整个胃肠道的不良事件，CSULGIE 终点有可能成为评估一系列治疗的胃肠道效果的标准工具。 （首次发布，2009 年 11 月 1 日；J Rheumatol 2010；37:167-74；doi:10.3899/jrheum.090168）
Objective. Nonsteroidal antinflammatory drugs (NSAID) not only cause damage to the upper gastrointestinal (GI) tract but also affect the lower GI tract. To date, there is no endpoint that evaluates serious GI events in the entire GI tract. The objective of this report is to introduce a novel composite endpoint that measures damage to the entire GI tract - clinically significant upper and lower GI events (CSULGIE) - in patients with NSAID-induced GI damage.Methods. We reviewed the data from largescale, multicenter, randomized, clinical trials on lower GI toxicity associated with NSAID use. The rationale for using CSULGIE as a primary endpoint in 2 ongoing trials - the Celecoxib vs Omeprazole and Diclofenac for At-risk Osteoarthritis (OA) and Rheumatoid Arthritis (RA) Patients (CONDOR) trial and the Gastrointestinal Randomized Events and Safety Open-Label NSAID Study (GI-REASONS) - is also discussed.Results. Previous randomized trials focused primarily on damage to the upper GI tract and often neglected the lower GI tract. The CSULGIE endpoint extends the traditional "perforation, obstruction, and bleeding" assessment of upper GI complications by including events in the lower GI tract (small/large bowel) such as perforation, bleeding, and clinically significant anemia.Conclusion. By providing clinicians with a new, descriptive language for adverse events through the entire GI tract, the CSULGIE endpoint has the potential to become a standard tool for evaluating the GI effects of a range of therapies. (First Release Nov 1 2009; J Rheumatol 2010;37:167-74; doi:10.3899/jrheum.090168)