Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.

Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.

Autor Bombardier, C. Google Scholar
Laine, L. Google Scholar
Reicin, A. Google Scholar
Shapiro, D. Google Scholar
Burgos-Vargas, R. Google Scholar
Davis, B. Google Scholar
Day, R. Google Scholar
Ferraz, M. B. Google Scholar
Hawkey, C. J. Google Scholar
Hochberg, M. C. Google Scholar
Kvien, T. K. Google Scholar
Schnitzer, T. J. Google Scholar
Weaver, A. Google Scholar
VIGOR Study Grp Google Scholar
Instituição Mt Sinai Hosp
Univ Hlth Network
Univ So Calif
Univ Nacl Autonoma Mexico
Merck & Co Inc
Hosp Gen Mexico
Univ Texas
Univ New S Wales
St Vincents Hosp
Universidade Federal de São Paulo (UNIFESP)
Univ Nottingham Hosp
Univ Maryland
Oslo City Dept Rheumatol
Diakonhjemmet Hosp
Northwestern Univ
Resumo 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. (N Engl J Med 2000;343:1520-8.) (C) 2000, Massachusetts Medical Society.
Idioma Inglês
Data 2000-11-23
Publicado em New England Journal of Medicine. Waltham: Massachusetts Medical Soc, v. 343, n. 21, p. 1520-1528, 2000.
ISSN 0028-4793 (Sherpa/Romeo, fator de impacto)
Editor Massachusetts Medical Soc
Extensão 1520-1528
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000165410900003

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