2011
Evaluation of NT-proBNP and high sensitivity C-reactive protein for predicting cardiovascular risk in patients with arthritis taking longterm nonsteroidal antiinflammatory drugs.
Ruff CT, Morrow DA, Jarolim P, Ren F, Contant CF, Kaur A, Curtis SP, Laine L, Cannon CP, Brune K. Evaluation of NT-proBNP and high sensitivity C-reactive protein for predicting cardiovascular risk in patients with arthritis taking longterm nonsteroidal antiinflammatory drugs. The Journal Of Rheumatology 2011, 38: 1071-8. PMID: 21459935, DOI: 10.3899/jrheum.100880.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidBiomarkersC-Reactive ProteinCardiovascular DiseasesDiclofenacEtoricoxibFemaleHeart FailureHumansLongitudinal StudiesMaleMiddle AgedMyocardial InfarctionNatriuretic Peptide, BrainOsteoarthritisPeptide FragmentsProspective StudiesPyridinesRetrospective StudiesRisk FactorsSulfonesThrombosisTreatment OutcomeConceptsHigh-sensitivity C-reactive proteinNonsteroidal antiinflammatory drugsSensitivity C-reactive proteinNT-proBNPC-reactive proteinHeart failureCV eventsCV outcomesCV riskThrombotic eventsMyocardial infarctionAntiinflammatory drugsBiomarkers N-terminal pro-B-type natriuretic peptideCardiac biomarkers N-terminal pro-B-type natriuretic peptideN-terminal pro-B-type natriuretic peptidePro-B-type natriuretic peptideChronic nonsteroidal antiinflammatory drugsBaseline NT-proBNPChronic NSAID treatmentLow CV riskNT-proBNP levelsFuture cardiovascular eventsBody mass indexIdentification of patientsTypes of arthritis
2010
Risk factors for NSAID‐associated upper GI clinical events in a long‐term prospective study of 34 701 arthritis patients
Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP. Risk factors for NSAID‐associated upper GI clinical events in a long‐term prospective study of 34 701 arthritis patients. Alimentary Pharmacology & Therapeutics 2010, 32: 1240-1248. PMID: 20955443, DOI: 10.1111/j.1365-2036.2010.04465.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalArthritisCyclooxygenase 2 InhibitorsDiclofenacEtoricoxibFemaleGastrointestinal DiseasesHumansMaleMiddle AgedProportional Hazards ModelsProspective StudiesPyridinesRisk FactorsSulfonesTime FactorsUpper Gastrointestinal TractConceptsClinical eventsRisk factorsLow-dose aspirin useDouble-blind randomized trialsLong-term prospective studiesCox proportional hazards modelNonsteroidal anti-inflammatory drugsDiscontinuation of NSAIDsPredictors of discontinuationUpper GI eventsLow-dose aspirinPotential risk factorsProportional hazards modelAnti-inflammatory drugsAspirin useGI eventsPatient characteristicsArthritis patientsTreat analysisRandomized trialsRheumatoid arthritisProspective studyGI effectsDyspepsiaHazards model
2009
Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program
Krum H, Curtis SP, Kaur A, Wang H, Smugar SS, Weir MR, Laine L, Brater DC, Cannon CP. Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program. European Journal Of Heart Failure 2009, 11: 542-550. PMID: 19380329, DOI: 10.1093/eurjhf/hfp054.Peer-Reviewed Original ResearchConceptsCongestive heart failureHistory of CHFHazard ratioHeart failureRisk markersRisk factorsIncidence of CHFRisk of CHFMultivariate analysisCox proportional hazards modelNon-steroidal anti-inflammatory drugsBaseline risk factorsHistory of hypertensionEmergency room visitsSignificant risk factorsDose-related increaseSignificant risk markerProportional hazards modelAnti-inflammatory drugsImpact of treatmentEtoricoxib 60CHF hospitalizationBaseline factorsRoom visitsCHF eventsFactors associated with blood pressure changes in patients receiving diclofenac or etoricoxib: results from the MEDAL study
Krum H, Swergold G, Curtis SP, Kaur A, Wang H, Smugar SS, Weir MR, Laine L, Brater DC, Cannon CP. Factors associated with blood pressure changes in patients receiving diclofenac or etoricoxib: results from the MEDAL study. Journal Of Hypertension 2009, 27: 886-893. PMID: 19516186, DOI: 10.1097/hjh.0b013e328325d831.Peer-Reviewed Original ResearchConceptsCalcium channel blockersHistory of hypertensionBlood pressureAntihypertensive classesDiastolic BPRisk factorsAntihypertensive drug classesHypertension risk factorsDiastolic blood pressureSystolic blood pressureBlood pressure changesAntihypertensive medicationsMultinational EtoricoxibNSAID therapyHypertensive effectAntihypertensive effectArthritis patientsDrug classesChannel blockersNonsignificant decreaseMultivariate analysisSBPLong-term studiesEtoricoxibHypertensionCardiovascular safety and gastrointestinal tolerability of etoricoxib vs diclofenac in a randomized controlled clinical trial (The MEDAL study)
Combe B, Swergold G, McLay J, McCarthy T, Zerbini C, Emery P, Connors L, Kaur A, Curtis S, Laine L, Cannon CP. Cardiovascular safety and gastrointestinal tolerability of etoricoxib vs diclofenac in a randomized controlled clinical trial (The MEDAL study). Rheumatology 2009, 48: 425-432. PMID: 19223284, DOI: 10.1093/rheumatology/kep005.Peer-Reviewed Original ResearchConceptsThrombotic CV eventsHazard ratioCV eventsBlood pressureEfficacy parametersMaximum average changeAdverse event discontinuation rateDouble-blind studyMean treatment durationCohort of patientsSystolic blood pressureEtoricoxib 60Cardiovascular safetyGastrointestinal tolerabilityPrimary endpointRA cohortRA patientsTolerability profileAverage changeDiscontinuation ratesOA patientsPatient cohortClinical trialsSimilar efficacyTreatment durationHow Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial
Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, Cannon CP. How Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial. The American Journal Of Gastroenterology 2009, 104: ajg2008149. PMID: 19174782, DOI: 10.1038/ajg.2008.149.Peer-Reviewed Original ResearchConceptsLiver-related hospitalizationsNon-steroidal anti-inflammatory drugsMonths of therapyAminotransferase elevationLiver eventsClinical trialsLong-term prospective clinical trialsLarge double-blind trialDeath/transplantHepatotoxicity of diclofenacTransplant/deathDouble-blind trialPrescribed non-steroidal anti-inflammatory drugsProspective clinical trialsAdverse hepatic effectsALT/ASTRates of laboratoryAnti-inflammatory drugsProspective trialArthritis patientsLiver injuryRheumatoid arthritisClinical eventsHepatic diseaseCausality assessment
2008
Lower Gastrointestinal Events in a Double-Blind Trial of the Cyclo-Oxygenase-2 Selective Inhibitor Etoricoxib and the Traditional Nonsteroidal Anti-Inflammatory Drug Diclofenac
Laine L, Curtis SP, Langman M, Jensen DM, Cryer B, Kaur A, Cannon CP. Lower Gastrointestinal Events in a Double-Blind Trial of the Cyclo-Oxygenase-2 Selective Inhibitor Etoricoxib and the Traditional Nonsteroidal Anti-Inflammatory Drug Diclofenac. Gastroenterology 2008, 135: 1517-1525. PMID: 18823986, DOI: 10.1053/j.gastro.2008.07.067.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalConfidence IntervalsCyclooxygenase InhibitorsDiclofenacDose-Response Relationship, DrugEtoricoxibFemaleFollow-Up StudiesGastrointestinal HemorrhageHumansIncidenceMaleMiddle AgedOdds RatioOsteoarthritisProspective StudiesPyridinesRisk FactorsSulfonesTreatment OutcomeConceptsLower GI eventsClinical eventsGI eventsRisk factorsCOX-2 selective inhibitorsBlinded adjudication committeeLower Gastrointestinal EventsTraditional NSAID diclofenacUpper GI eventsDouble-blind trialSignificant risk factorsMajor risk factorAnti-inflammatory drugsSelective inhibitorNonsteroidal anti-inflammatory drug diclofenacGastrointestinal eventsNSAID useProspective trialMultivariable analysisRheumatoid arthritisAdjudication committeeMean durationCyclo-oxygenaseNSAID diclofenacAbstractText
2007
Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison
Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP, Committee F. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. The Lancet 2007, 369: 465-473. PMID: 17292766, DOI: 10.1016/s0140-6736(07)60234-7.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalArthritisArthritis, RheumatoidAspirinCyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDiclofenacEtoricoxibFemaleGastrointestinal DiseasesGastrointestinal HemorrhageHumansMaleMiddle AgedOsteoarthritisPeptic UlcerPlatelet Aggregation InhibitorsProton Pump InhibitorsPyridinesSulfonesConceptsProton pump inhibitorsNon-steroidal anti-inflammatory drugsUpper gastrointestinal safetyLow-dose aspirinClinical eventsGastrointestinal safetyRheumatoid arthritisUncomplicated eventsTraditional non-steroidal anti-inflammatory drugsConcomitant proton pump inhibitorsLow-dose aspirin useCOX-2 selective inhibitorsTraditional NSAID diclofenacAnti-inflammatory drugsStandard clinical practiceSelective inhibitorGastrointestinal eventsMultinational EtoricoxibAspirin useGastrointestinal outcomesTreat analysisProtective therapyPump inhibitorsCyclo-oxygenaseNSAID diclofenac
2006
Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison
Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, Reicin AS, Bombardier C, Weinblatt ME, van der Heijde D, Erdmann E, Laine L, Committee F. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. The Lancet 2006, 368: 1771-1781. PMID: 17113426, DOI: 10.1016/s0140-6736(06)69666-9.Peer-Reviewed Original ResearchConceptsThrombotic cardiovascular eventsNon-steroidal anti-inflammatory drugsCardiovascular eventsHazard ratioRheumatoid arthritisCyclo-oxygenase-2 (COX-2) selective inhibitorsTraditional non-steroidal anti-inflammatory drugsCOX-2 selective inhibitorsPrespecified pooled analysisRelative cardiovascular riskTraditional NSAID diclofenacUpper gastrointestinal eventsPlacebo-controlled trialAverage treatment durationAnti-inflammatory drugsSelective inhibitorLong-term useDiclofenac groupEtoricoxib groupGastrointestinal eventsMultinational EtoricoxibCardiovascular outcomesCardiovascular riskTreat analysisClinical eventsClinical trial design and patient demographics of the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Study Program: Cardiovascular outcomes with etoricoxib versus diclofenac in patients with osteoarthritis and rheumatoid arthritis
Cannon CP, Curtis SP, Bolognese JA, Laine L, Committee F. Clinical trial design and patient demographics of the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Study Program: Cardiovascular outcomes with etoricoxib versus diclofenac in patients with osteoarthritis and rheumatoid arthritis. American Heart Journal 2006, 152: 237-245. PMID: 16875903, DOI: 10.1016/j.ahj.2006.05.024.Peer-Reviewed Original ResearchMeSH KeywordsAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidAspirinCyclooxygenase InhibitorsDiclofenacDouble-Blind MethodEtoricoxibFemaleHumansMaleMiddle AgedMulticenter Studies as TopicOsteoarthritisPatient SelectionPyridinesRandomized Controlled Trials as TopicResearch DesignRisk AssessmentSulfonesTreatment OutcomeConceptsNonsteroidal anti-inflammatory drugsAnnual event rateThrombotic cardiovascular eventsRheumatoid arthritisCardiovascular eventsEvent ratesHazard ratioTraditional nonsteroidal anti-inflammatory drugsCyclooxygenase-2 selective inhibitorCOX-2 selective inhibitorsTraditional NSAID diclofenacDouble-blind trialCardiovascular event ratesTreatment of patientsAnti-inflammatory drugsClinical trial designSelective inhibitorLong-term useMultinational EtoricoxibCardiovascular outcomesCardiovascular riskPatient demographicsNoninferiority criteriaControl armCOX-2
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