2004
Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial
Laine L, Maller ES, Yu C, Quan H, Simon T. Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial. Gastroenterology 2004, 127: 395-402. PMID: 15300570, DOI: 10.1053/j.gastro.2004.05.001.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalAspirinCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDouble-Blind MethodDrug Therapy, CombinationFemaleGastric MucosaHumansIbuprofenIncidenceIsoenzymesLactonesMaleMembrane ProteinsMiddle AgedOsteoarthritisProstaglandin-Endoperoxide SynthasesRisk FactorsStomach UlcerSulfonesTablets, Enteric-CoatedConceptsNonselective nonsteroidal anti-inflammatory drugsLow-dose aspirinCOX-2 selective inhibitorsDouble-blind trialUlcer incidenceNonselective NSAIDsLow-dose enteric-coated aspirinLow-dose aspirin usersCyclooxygenase-2 selective inhibitorSelective inhibitorNonsteroidal anti-inflammatory drugsEnteric-coated aspirinGastrointestinal mucosal injuryNumber of erosionsRisk of ulcerAnti-inflammatory drugsCOX-2 selective inhibitionYears of ageBaseline endoscopyAspirin usersDose aspirinErosive esophagitisCumulative incidenceMucosal injuryRepeat endoscopy
2003
Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study
Hawkey CJ, Laine L, Simon T, Quan H, Shingo S, Evans J. Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study. Gut 2003, 52: 820. PMID: 12740337, PMCID: PMC1773685, DOI: 10.1136/gut.52.6.820.Peer-Reviewed Original ResearchConceptsNon-selective non-steroidal antiinflammatory drugsGastroduodenal ulcersAdverse eventsRheumatoid arthritisLess gastrointestinal damageSecondary end pointsClinical adverse eventsDouble-blind studyRheumatoid arthritis patientsLog-rank testNon-steroidal antiinflammatory drugsGastroduodenal erosionsCumulative incidenceGastrointestinal damageArthritis patientsDuodenal ulcerLifetable analysisOverall incidenceSelective cyclooxygenaseAntiinflammatory drugsLower incidenceBlind studyMean changeTreatment groupsPlacebo
2002
Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis
Laine L, Bombardier C, Hawkey CJ, Davis B, Shapiro D, Brett C, Reicin A. Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology 2002, 123: 1006-1012. PMID: 12360461, DOI: 10.1053/gast.2002.36013.Peer-Reviewed Original ResearchConceptsUpper GI eventsClinical upper GI eventsSelective cyclooxygenase-2 inhibitorHigh-risk patientsGI eventsRisk factorsCyclooxygenase-2 inhibitorClinical characteristicsRheumatoid arthritisClinical eventsNonsteroidal anti-inflammatory drugsClinical GI eventsRisk of NSAIDUpper GI complicationsLow-risk patientsSevere rheumatoid arthritisPatients' clinical characteristicsRheumatoid arthritis patientsAbsolute risk reductionLow-risk subgroupsAnti-inflammatory drugsIndividual risk factorsRisk of eventsGI complicationsNonselective NSAIDs
2000
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
1999
A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2–specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis
Laine L, Harper S, Simon T, Bath R, Johanson J, Schwartz H, Stern S, Quan H, Bolognese J, Group F. A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2–specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Gastroenterology 1999, 117: 776-783. PMID: 10500058, DOI: 10.1016/s0016-5085(99)70334-3.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDouble-Blind MethodDuodenal UlcerFemaleGastric MucosaGastroscopyHumansIbuprofenIntestinal MucosaIsoenzymesLactonesMaleMembrane ProteinsMiddle AgedOsteoarthritisProstaglandin-Endoperoxide SynthasesStomach UlcerSulfonesConceptsUlcer ratesGastroduodenal ulcersCOX-2 specific inhibitionSymptoms of osteoarthritisNonspecific COX inhibitorNormal gastrointestinal tractTreatment of patientsBaseline endoscopyGastroduodenal ulcerationPlacebo groupCumulative incidenceOsteoarthritis patientsGastroduodenal mucosaWeek 12COX inhibitorsMucosal integrityCOX-2Gastrointestinal tractInflammatory sitesProstaglandin productionDoses 2AbstractTextEffective doseUlcersPatients