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Previous Volume 343:1520-1528 November 23, 2000 Number 21 Next

	Full Text PDF Supplementary Disclosure Editorial by Curfman, G. D. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis.

Methods We randomly assigned 8076 patients who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis to receive either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily. The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers).

Results Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis. During a median follow-up of 9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6; P<0.001). The respective rates of complicated confirmed events (perforation, obstruction, and severe upper gastrointestinal bleeding) were 0.6 per 100 patient-years and 1.4 per 100 patient-years (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.005). The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7); the overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups.

Conclusions In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor.

Source Information

From the Institute for Work and Health, Mount Sinai Hospital, and the University Health Network, Toronto (C.B.); the Gastrointestinal Division, Department of Medicine, University of Southern California School of Medicine, Los Angeles (L.L.); Merck, Rahway, N.J. (A.R., D.S.); the Faculty of Medicine and Research Division, Universidad Nacional Autonoma de Mexico, and Hospital General de Mexico, Mexico City, Mexico (R.B.-V.); University of Texas–Houston School of Public Health, Houston (B.D.); the Department of Clinical Pharmacology, University of New South Wales and St. Vincent's Hospital, Sydney, Australia (R.D.); the Division of Rheumatology, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil (M.B.F.); the Division of Gastroenterology, School of Medical and Surgical Sciences, University Hospital, Nottingham, United Kingdom (C.J.H.); the Division of Rheumatology and Clinical Immunology, University of Maryland, Baltimore (M.C.H.); Oslo City Department of Rheumatology, and Diakonhjemmet Hospital, Oslo, Norway (T.K.K.); and the Office of Clinical Research and Training, Northwestern University School of Medicine, Chicago (T.J.S.). Arthur Weaver, M.D., Arthritis Center of Nebraska, Lincoln, was another author.

Address reprint requests to Dr. Bombardier at the Institute for Work and Health, 250 Bloor St. E., Suite 702, Toronto, ON M4W 1E6, Canada, or at claire.bombardier{at}utoronto.ca.

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