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Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use.
Gastroenterology. 2003 Feb; 124(2):288-92.G

Abstract

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+Show Affiliations

University of Southern California School of Medicine, Los Angeles 90033, USA. LLAINE@USC.EDUNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12557133

Citation

Laine, Loren, et al. "Serious Lower Gastrointestinal Clinical Events With Nonselective NSAID or Coxib Use." Gastroenterology, vol. 124, no. 2, 2003, pp. 288-92.
Laine L, Connors LG, Reicin A, et al. Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use. Gastroenterology. 2003;124(2):288-92.
Laine, L., Connors, L. G., Reicin, A., Hawkey, C. J., Burgos-Vargas, R., Schnitzer, T. J., Yu, Q., & Bombardier, C. (2003). Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use. Gastroenterology, 124(2), 288-92.
Laine L, et al. Serious Lower Gastrointestinal Clinical Events With Nonselective NSAID or Coxib Use. Gastroenterology. 2003;124(2):288-92. PubMed PMID: 12557133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use. AU - Laine,Loren, AU - Connors,Laurine G, AU - Reicin,Alise, AU - Hawkey,Christopher J, AU - Burgos-Vargas,Ruben, AU - Schnitzer,Thomas J, AU - Yu,Qinfen, AU - Bombardier,Claire, PY - 2003/1/31/pubmed PY - 2003/3/19/medline PY - 2003/1/31/entrez SP - 288 EP - 92 JF - Gastroenterology JO - Gastroenterology VL - 124 IS - 2 N2 - 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. SN - 0016-5085 UR - https://www.unboundmedicine.com/medline/citation/12557133/Serious_lower_gastrointestinal_clinical_events_with_nonselective_NSAID_or_coxib_use_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016508502159051 DB - PRIME DP - Unbound Medicine ER -