RT Journal Article
SR Electronic
T1 A Novel Composite Endpoint to Evaluate the Gastrointestinal (GI) Effects of Nonsteroidal Antiinflammatory Drugs Through the Entire GI Tract
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 167
OP 174
DO 10.3899/jrheum.090168
VO 37
IS 1
A1 FRANCIS K. L. CHAN
A1 BYRON CRYER
A1 JAY L. GOLDSTEIN
A1 ANGEL LANAS
A1 DAVID A. PEURA
A1 JAMES M. SCHEIMAN
A1 LEE S. SIMON
A1 GURKIRPAL SINGH
A1 MARTIN J. STILLMAN
A1 CHARLES M. WILCOX
A1 MANUELA F. BERGER
A1 AURORA BREAZNA
A1 WILLIAM DODGE
YR 2010
UL http://www.jrheum.org/content/37/1/167.abstract
AB Objective. Nonsteroidal antiinflammatory 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.