Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis
Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz M, Hawkey C, Hochberg M, Kvien T, Schnitzer T. Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis. New England Journal Of Medicine 2000, 343: 1520-1528. PMID: 11087881, DOI: 10.1056/nejm200011233432103.Peer-Reviewed Original ResearchMeSH KeywordsAdultArthritis, RheumatoidCardiovascular DiseasesCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDuodenal ObstructionFemaleGastric Outlet ObstructionGastrointestinal DiseasesGastrointestinal HemorrhageHumansIsoenzymesLactonesMaleMembrane ProteinsMiddle AgedNaproxenPeptic UlcerProportional Hazards ModelsProstaglandin-Endoperoxide SynthasesSulfonesConceptsUpper gastrointestinal eventsNonselective nonsteroidal antiinflammatory drugsGastrointestinal eventsRheumatoid arthritisCyclooxygenase-2Upper gastrointestinal toxicityPercent of patientsPrimary end pointOverall mortality rateNonsteroidal antiinflammatory drugsRate of deathYears of ageNonselective NSAID naproxenSelective inhibitorCardiovascular causesRofecoxib groupGastrointestinal toxicityNaproxen groupMyocardial infarctionSimilar efficacyAntiinflammatory drugsLower incidenceArthritisMortality ratePatientsComparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: A randomized, double‐blind, placebo‐controlled trial
Hawkey C, Laine L, Simon T, Beaulieu A, Maldonado‐Cocco J, Acevedo E, Shahane A, Quan H, Bolognese J, Mortensen E. Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: A randomized, double‐blind, placebo‐controlled trial. Arthritis & Rheumatism 2000, 43: 370-377. PMID: 10693877, DOI: 10.1002/1529-0131(200002)43:2<370::aid-anr17>3.0.co;2-d.Peer-Reviewed Original ResearchConceptsGastroduodenal ulcersPrespecified criteriaEffect of rofecoxibPlacebo-controlled trialSecondary end pointsDouble-blind studyGastroduodenal ulcerationGastroduodenal mucosaUlcer incidenceCyclooxygenase-2Side effectsUlcersEnd pointEffective doseRofecoxibWeeksPlaceboPatientsOsteoarthritisIncidenceDoseIbuprofenUlcerationMucosaEndoscopy