Document Detail

Gastrointestinal safety of coxibs and outcomes studies: what's the verdict?
MedLine Citation:
PMID:  11992743     Owner:  NLM     Status:  MEDLINE    
Although nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used, their main limitation is gastrointestinal (GI) injury. Two double-blind, randomized, outcomes trials were conducted to determine the incidence of clinical GI events with the coxibs, rofecoxib and celecoxib, compared with nonselective NSAIDs. The VIGOR study (VIOXX Gastrointestinal Outcomes Research) compared rofecoxib with naproxen, and the CLASS study (Celecoxib Long-term Arthritis Safety Study) compared celecoxib with ibuprofen and diclofenac. The VIGOR trial revealed a relative risk reduction for clinical upper GI events of 50% with rofecoxib, and a 60% reduction in complicated events. In the CLASS study, the 23% reduction in complicated ulcers with celecoxib did not reach statistical significance (P = 0.45), although when all clinical events were examined, the 34% reduction was significant (P = 0.04). However, low-dose aspirin use, which was allowed in the CLASS study, may have influenced the results. A subgroup analysis in the patients who did not take aspirin revealed a nonsignificant 45% reduction in complicated events with celecoxib (P = 0.19), and a 47% reduction in complicated and symptomatic ulcers (P = 0.02).
Loren Laine
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Journal of pain and symptom management     Volume:  23     ISSN:  0885-3924     ISO Abbreviation:  J Pain Symptom Manage     Publication Date:  2002 Apr 
Date Detail:
Created Date:  2002-05-06     Completed Date:  2002-05-29     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8605836     Medline TA:  J Pain Symptom Manage     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S5-10; discussion S11-4     Citation Subset:  IM    
GI Division, Department of Medicine, University of Southern California School of Medicine, Los Angeles, CA 90033, USA.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*,  therapeutic use
Clinical Trials as Topic
Cyclooxygenase 2
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors / adverse effects*,  therapeutic use
Gastrointestinal Diseases / chemically induced*,  pathology
Membrane Proteins
Prostaglandin-Endoperoxide Synthases
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Cyclooxygenase 2 Inhibitors; 0/Cyclooxygenase Inhibitors; 0/Isoenzymes; 0/Membrane Proteins; EC 2; EC protein, human; EC Synthases

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