Chan FK, Cryer B, Goldstein JL, Lanas A, Peura DA, Scheiman JM, Simon LS, Singh G, Stillman MJ, Wilcox CM, Berger MF, Breazna A, Dodge W
A Novel Composite Endpoint to Evaluate the Gastrointestinal (GI) Effects of Nonsteroidal Antiinflammatory Drugs Through the Entire GI Tract. [JOURNAL ARTICLE]
J Rheumatol 2009 Nov 2.
OBJECTIVE: To introduce a novel composite endpoint that measures damage to the entire gastrointestinal (GI) tract-clinically significant upper and lower GI events (CSULGIE)-in patients with nonsteroidal antiinflammatory drug (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.
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