Document Detail

Outcomes studies of the gastrointestinal safety of cyclooxygenase-2 inhibitors.
MedLine Citation:
PMID:  12086292     Owner:  NLM     Status:  MEDLINE    
Short-term endoscopic studies of the highly selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) rofecoxib and celecoxib have shown that these agents are well tolerated and have efficacy equivalent to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with fewer adverse effects on the upper gastrointestinal (GI) tract. These studies are limited, however, as the detection of endoscopic lesions is not well correlated with symptomatic ulcers and ulcer complications. Outcomes studies of the GI safety are, therefore, essential to understanding how coxibs are likely to perform in a clinical practice setting. Four large outcomes studies (Vioxx Gastrointestinal Outcomes Research, VIGOR; Assessment of Difference Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness trial, ADVANTAGE; Celecoxib Long-term Arthritis Safety Study, CLASS; and the Successive Celecoxib Efficacy and Safety Studies, SUCCESS) examined the GI safety of rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID (naproxen, ibuprofen, or diclofenac). Reduced risk of upper GI events was seen in patients with multiple risk factors and in patients using low-dose aspirin and corticosteroids concomitantly with a coxib. Results of large outcomes studies provide support for the COX-2 hypothesis and demonstrate the long-term safety and tolerability of coxibs.
James M Scheiman
Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Cleveland Clinic journal of medicine     Volume:  69 Suppl 1     ISSN:  0891-1150     ISO Abbreviation:  Cleve Clin J Med     Publication Date:  2002  
Date Detail:
Created Date:  2002-06-27     Completed Date:  2002-07-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8703441     Medline TA:  Cleve Clin J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  SI40-6     Citation Subset:  IM    
University of Michigan Medical School, Ann Arbor 48109-0362, USA.
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MeSH Terms
Arthritis / drug therapy
Clinical Trials as Topic
Controlled Clinical Trials as Topic
Cyclooxygenase 2
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors / adverse effects*,  therapeutic use
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Tolerance*
Evaluation Studies as Topic
Gastric Mucosa / drug effects*
Isoenzymes / antagonists & inhibitors*
Membrane Proteins
Prostaglandin-Endoperoxide Synthases
Reg. No./Substance:
0/Cyclooxygenase 2 Inhibitors; 0/Cyclooxygenase Inhibitors; 0/Isoenzymes; 0/Membrane Proteins; EC 2; EC protein, human; EC Synthases

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