Document Detail


Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use.
MedLine Citation:
PMID:  12557133     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND & AIMS: Epidemiologic studies suggest nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk for lower gastrointestinal (GI) clinical events, but data from prospective trials are lacking. Cyclooxygenase (COX)-2-selective inhibitors decrease upper GI clinical events but the effect on lower GI events has not been determined. We performed a post hoc analysis of serious lower GI clinical events with a nonselective NSAID and a COX-2-selective agent in a prospective, double-blind, randomized GI outcomes trial. METHODS: A total of 8076 rheumatoid arthritis patients 50 years or older (or 40 years or older on corticosteroid therapy) expected to require NSAIDs for 1 year or greater were randomly assigned to naproxen 500 mg twice daily or rofecoxib 50 mg daily. The rate of serious lower GI clinical events, defined as bleeding with a 2 g/dL drop in hemoglobin or hospitalization, or hospitalization for perforation, obstruction, ulceration, or diverticulitis, was determined. RESULTS: The rate of serious lower GI events per 100 patient-years was 0.41 for rofecoxib and 0.89 for naproxen (relative risk, 0.46; 95% confidence interval [CI], 0.22-0.93; P = 0.032). Serious lower GI events accounted for 39.4% of all serious GI events (complicated upper GI event or lower GI event) among patients taking naproxen and 42.7% among those taking rofecoxib. CONCLUSIONS: Serious lower GI events occurred at a rate of 0.9% per year in rheumatoid arthritis patients taking the nonselective NSAID naproxen, accounting for nearly 40% of the serious GI events that developed in these patients. Serious lower GI events were 54% lower with the use of the selective COX-2 inhibitor rofecoxib.
Authors:
Loren Laine; Laurine G Connors; Alise Reicin; Christopher J Hawkey; Ruben Burgos-Vargas; Thomas J Schnitzer; Qinfen Yu; Claire Bombardier
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Gastroenterology     Volume:  124     ISSN:  0016-5085     ISO Abbreviation:  Gastroenterology     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-01-30     Completed Date:  2003-03-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  288-92     Citation Subset:  AIM; IM    
Affiliation:
University of Southern California School of Medicine, Los Angeles 90033, USA. LLAINE@USC.EDU
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Arthritis, Rheumatoid / drug therapy*
Cyclooxygenase 2
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors / adverse effects*
Double-Blind Method
Female
Gastrointestinal Diseases / chemically induced*,  epidemiology
Humans
Incidence
Isoenzymes / antagonists & inhibitors
Lactones / adverse effects*
Male
Membrane Proteins
Middle Aged
Naproxen / adverse effects*
Prospective Studies
Prostaglandin-Endoperoxide Synthases
Sulfones
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Cyclooxygenase 2 Inhibitors; 0/Cyclooxygenase Inhibitors; 0/Isoenzymes; 0/Lactones; 0/Membrane Proteins; 0/Sulfones; 0/rofecoxib; 22204-53-1/Naproxen; EC 1.14.99.1/Cyclooxygenase 2; EC 1.14.99.1/PTGS2 protein, human; EC 1.14.99.1/Prostaglandin-Endoperoxide Synthases

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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