A novel composite endpoint to evaluate the gastrointestinal (GI) effects of nonsteroidal antiinflammatory drugs through the entire GI tract

Francis K L Chan, Byron Cryer, Jay L. Goldstein, Angel Lanas, David A. Peura, James M. Scheiman, Lee S. Simon, Gurkirpal Singh, Martin J. Stillman, Charles M. Wilcox, Manuela F. Berger, Aurora Breazna, William Dodge

Research output: Contribution to journalArticle

59 Citations (Scopus)

Abstract

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. The Journal of Rheumatology

Original languageEnglish (US)
Pages (from-to)167-174
Number of pages8
JournalJournal of Rheumatology
Volume37
Issue number1
DOIs
StatePublished - Jan 2010

Fingerprint

Lower Gastrointestinal Tract
Gastrointestinal Tract
Anti-Inflammatory Agents
Upper Gastrointestinal Tract
Celecoxib
Pharmaceutical Preparations
Hemorrhage
Gastrointestinal Agents
Omeprazole
Diclofenac
Rheumatology
Osteoarthritis
Anemia
Rheumatoid Arthritis
Language
Randomized Controlled Trials
Safety
Therapeutics

Keywords

  • Cyclooxygenase inhibitors
  • Nonsteroidal antiinflammatory agents
  • Osteoarthritis
  • Rheumatoid arthritis
  • Upper/lower gastrointestinal tract

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

A novel composite endpoint to evaluate the gastrointestinal (GI) effects of nonsteroidal antiinflammatory drugs through the entire GI tract. / Chan, Francis K L; Cryer, Byron; Goldstein, Jay L.; Lanas, Angel; Peura, David A.; Scheiman, James M.; Simon, Lee S.; Singh, Gurkirpal; Stillman, Martin J.; Wilcox, Charles M.; Berger, Manuela F.; Breazna, Aurora; Dodge, William.

In: Journal of Rheumatology, Vol. 37, No. 1, 01.2010, p. 167-174.

Research output: Contribution to journalArticle

Chan, FKL, Cryer, B, Goldstein, JL, Lanas, A, Peura, DA, Scheiman, JM, Simon, LS, Singh, G, Stillman, MJ, Wilcox, CM, Berger, MF, Breazna, A & Dodge, W 2010, 'A novel composite endpoint to evaluate the gastrointestinal (GI) effects of nonsteroidal antiinflammatory drugs through the entire GI tract', Journal of Rheumatology, vol. 37, no. 1, pp. 167-174. https://doi.org/10.3899/jrheum.090168
Chan, Francis K L ; Cryer, Byron ; Goldstein, Jay L. ; Lanas, Angel ; Peura, David A. ; Scheiman, James M. ; Simon, Lee S. ; Singh, Gurkirpal ; Stillman, Martin J. ; Wilcox, Charles M. ; Berger, Manuela F. ; Breazna, Aurora ; Dodge, William. / A novel composite endpoint to evaluate the gastrointestinal (GI) effects of nonsteroidal antiinflammatory drugs through the entire GI tract. In: Journal of Rheumatology. 2010 ; Vol. 37, No. 1. pp. 167-174.
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abstract = "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. The Journal of Rheumatology",
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