2015
The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial
Vardi M, Cryer BL, Cohen M, Lanas A, Schnitzer TJ, Lapuerta P, Goldsmith MA, Laine L, Doros G, Liu Y, McIntosh AI, Cannon CP, Bhatt DL. The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial. Alimentary Pharmacology & Therapeutics 2015, 42: 365-374. PMID: 26032114, PMCID: PMC4494867, DOI: 10.1111/apt.13260.Peer-Reviewed Original ResearchConceptsDual anti-platelet therapyAnti-platelet therapyGastrointestinal Event TrialLow-dose aspirinNonpain symptomsEvents trialPatient-reported outcome dataPercent of patientsPatient-reported symptomsPatient-reported outcomesPatient-reported severityOmeprazole groupProphylactic omeprazoleCardiovascular safetyGastrointestinal bleedingPain intensityClinical eventsOmeprazole useClinical significanceOutcome dataAssessment QuestionnaireClopidogrelDyspepsiaTherapyPatients
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
How 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 eventsReview article: gastrointestinal bleeding with low‐dose aspirin – what's the risk?
LAINE L. Review article: gastrointestinal bleeding with low‐dose aspirin – what's the risk? Alimentary Pharmacology & Therapeutics 2006, 24: 897-908. PMID: 16948802, DOI: 10.1111/j.1365-2036.2006.03077.x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsLow-dose aspirinGastrointestinal bleedingPlacebo-controlled trialRelative riskNon-aspirin non-steroidal anti-inflammatory drugsLarge Danish cohort studyRandomized placebo-controlled trialNon-steroidal anti-inflammatory drugsAbsolute annual incidenceDanish cohort studyMajor gastrointestinal bleedingUpper gastrointestinal bleedingEnteric-coated aspirinAbsolute rate increaseAnti-inflammatory drugsEndoscopic trialsCorticosteroid useAnticoagulant therapyCardiovascular benefitsCohort studyAnnual incidenceVascular protectionClinical eventsUlcer incidenceOdds ratioSystematic review: the lower gastrointestinal adverse effects of non‐steroidal anti‐inflammatory drugs
LAINE L, SMITH R, MIN K, CHEN C, DUBOIS RW. Systematic review: the lower gastrointestinal adverse effects of non‐steroidal anti‐inflammatory drugs. Alimentary Pharmacology & Therapeutics 2006, 24: 751-767. PMID: 16918879, DOI: 10.1111/j.1365-2036.2006.03043.x.Peer-Reviewed Original ResearchConceptsNon-steroidal anti-inflammatory drugsLower gastrointestinal adverse effectsLower gastrointestinal injuryGastrointestinal adverse effectsAnti-inflammatory drugsGastrointestinal injuryGastrointestinal effectsClinical eventsAdverse effectsNon-selective non-steroidal anti-inflammatory drugsUpper gastrointestinal effectsHigh-quality trialsLower gastrointestinal tractEndoscopic studyGastrointestinal integrityGastrointestinal tractComputerized databaseCoxibsDisease StudyInjuryLower ratesTrialsDrugsCohortLess effectGI Risk and Risk Factors of NSAIDs
Laine L. GI Risk and Risk Factors of NSAIDs. Journal Of Cardiovascular Pharmacology 2006, 47: s60-s66. PMID: 16785831, DOI: 10.1097/00005344-200605001-00011.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsNonsteroidal anti-inflammatory drugsUpper GI eventsClinical eventsNSAID useGI eventsRisk factorsMultiple nonsteroidal anti-inflammatory drugsNon-NSAID analgesicsUpper GI symptomsUse of coxibsUpper gastrointestinal complicationsUse of corticosteroidsRegular NSAID useImportant risk factorLowest effective doseAnti-inflammatory drugsGastrointestinal complicationsGI symptomsAnnual incidenceRisk stratificationGI riskRelative riskPrior historyEffective doseOlder age
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