2000
Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial
Silverstein F, Faich G, Goldstein J, Simon L, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal N, Stenson W, Burr A, Zhao W, Kent J, Lefkowith J, Verburg K, Geis G. Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial. JAMA 2000, 284: 1247-1255. PMID: 10979111, DOI: 10.1001/jama.284.10.1247.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidAspirinCelecoxibCyclooxygenase 1Cyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDiclofenacDouble-Blind MethodFemaleGastrointestinal DiseasesHumansIbuprofenIsoenzymesMaleMembrane ProteinsMiddle AgedOsteoarthritisPeptic UlcerProportional Hazards ModelsProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesSulfonamidesConceptsNonsteroidal anti-inflammatory drugsConventional nonsteroidal anti-inflammatory drugsCelecoxib Long-term Arthritis Safety StudyCOX-2-specific inhibitorsUlcer complicationsSymptomatic ulcersAnti-inflammatory drugsRheumatoid arthritisIncidence rateAspirin useLower incidenceChronic GI blood lossToxic effectsAdverse effectsCelecoxib-treated patientsUpper GI toxicityUpper GI ulcersGI blood lossInhibition of cyclooxygenaseGI intoleranceCardiovascular eventsGastrointestinal toxicityGI toxicityImportant toxic effectsStudy drug
1989
Issues in planning and interpreting active control equivalence studies
Makuch R, Johnson M. Issues in planning and interpreting active control equivalence studies. Journal Of Clinical Epidemiology 1989, 42: 503-511. PMID: 2661729, DOI: 10.1016/0895-4356(89)90146-7.Peer-Reviewed Original ResearchConceptsActive control equivalence studiesEquivalence studyActive-control equivalence trialsPrevention of strokeNew drugsActive control drugActive control treatmentAlternative study designsCurrent therapiesPlaceboControl drugTherapeutic equivalenceEquivalence trialNew treatmentsMethodologic issuesDrug efficacyStudy designTreatment controlDrugsEfficacyEquivalence designTrialsTreatmentStudy validation