2014
NSAID-Associated Gastrointestinal Bleeding: Assessing the Role of Concomitant Medications
Laine L. NSAID-Associated Gastrointestinal Bleeding: Assessing the Role of Concomitant Medications. Gastroenterology 2014, 147: 730-733. PMID: 25167988, DOI: 10.1053/j.gastro.2014.08.021.Commentaries, Editorials and LettersAnti-Inflammatory Agents, Non-SteroidalAspirinCyclooxygenase InhibitorsGastrointestinal HemorrhageHumans
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 eventsCardiovascular 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 diclofenacAbstractTextGastric Mucosal Defense and Cytoprotection: Bench to Bedside
Laine L, Takeuchi K, Tarnawski A. Gastric Mucosal Defense and Cytoprotection: Bench to Bedside. Gastroenterology 2008, 135: 41-60. PMID: 18549814, DOI: 10.1053/j.gastro.2008.05.030.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsCyclooxygenase InhibitorsGastric MucosaGastritisHumansStomach UlcerConceptsStress-related mucosal diseaseProton pump inhibitorsMucosal defenseGastric mucosal defenseMucosal injuryNoxious factorsNonsteroidal anti-inflammatory drugsCOX-2 selective inhibitorsGeneration of PGsImportant clinical sequelaeUpper gastrointestinal complicationsHigh-risk patientsModern intensive careAbsolute risk reductionInhibition of cyclooxygenaseAnti-inflammatory drugsContinuous blood flowGastrointestinal complicationsClinical sequelaePharmacologic therapyAntisecretory drugsSignificant bleedingAnnual incidenceIntensive careSensory innervation
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
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
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 endoscopyUtilization of nonsteroidal anti-inflammatory drugs and antisecretory agents: a managed care claims analysis
Ofman JJ, Badamgarav E, Henning JM, Knight K, Laine L. Utilization of nonsteroidal anti-inflammatory drugs and antisecretory agents: a managed care claims analysis. The American Journal Of Medicine 2004, 116: 835-842. PMID: 15178499, DOI: 10.1016/j.amjmed.2004.02.028.Peer-Reviewed Original ResearchConceptsCOX-2 inhibitorsCardiac eventsHealth care costsGastrointestinal bleedingTraditional NSAIDsHigh riskGreater total health care costsNonsteroidal anti-inflammatory drug therapyCare costsAnti-inflammatory drug therapyCOX-2 inhibitor therapyTotal health care costsCyclooxygenase-2 selective inhibitorNonsteroidal anti-inflammatory drugsCardiac risk profileProton pump inhibitorsAnti-inflammatory drugsLogistic regression analysisNSAID therapyNSAID usersGastrointestinal riskInhibitor useNonselective NSAIDsInhibitor therapyCardiac riskGuidelines for the appropriate use of non‐steroidal anti‐inflammatory drugs, cyclo‐oxygenase‐2‐specific inhibitors and proton pump inhibitors in patients requiring chronic anti‐inflammatory therapy
Dubois RW, Melmed GY, Henning JM, Laine L. Guidelines for the appropriate use of non‐steroidal anti‐inflammatory drugs, cyclo‐oxygenase‐2‐specific inhibitors and proton pump inhibitors in patients requiring chronic anti‐inflammatory therapy. Alimentary Pharmacology & Therapeutics 2004, 19: 197-208. PMID: 14723611, DOI: 10.1111/j.0269-2813.2004.01834.x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsProton pump inhibitorsCost of NSAIDsPump inhibitorsGastrointestinal eventsChronic anti-inflammatory therapyRAND/UCLA Appropriateness MethodNon-steroidal anti-inflammatory drugsAnti-inflammatory therapyAnti-inflammatory drugsDrug treatment strategiesCommunity-based settingsCardiovascular riskProphylactic useAppropriateness MethodTreatment strategiesLower riskNSAIDsPatientsClinical scenariosAspirinAppropriate useInhibitorsRiskCare entitiesLiterature reviewProton pump inhibitor co-therapy with nonsteroidal anti-inflammatory drugs--nice or necessary?
Laine L. Proton pump inhibitor co-therapy with nonsteroidal anti-inflammatory drugs--nice or necessary? Gastroenterological Disorders 2004, 4 Suppl 4: s33-41. PMID: 15580145.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAnimalsAnti-Inflammatory Agents, Non-SteroidalAspirinCyclooxygenase InhibitorsDrug Therapy, CombinationHumansMisoprostolProton Pump InhibitorsRisk FactorsStomach UlcerConceptsNonsteroidal anti-inflammatory drugsUpper GI symptomsNonselective nonsteroidal anti-inflammatory drugsLow-dose aspirinAnti-inflammatory drugsGI symptomsGI complicationsGI riskSide effectsDevelopment of NSAIDDaily proton pump inhibitor therapyHistamine-2 receptor antagonistsNSAID-induced gastric ulcersProton pump inhibitor therapyNSAID-induced ulcersGI side effectsUpper GI bleedingAnti-pyretic effectsGastrointestinal toxicityGI bleedingNSAID usersUlcer complicationsCardiovascular prophylaxisInhibitor therapyStandard doses
2003
Gastrointestinal health care resource utilization with chronic use of COX-2-specific inhibitors versus traditional NSAIDs1 1The Institute for Effectiveness Research, LLC, is a subsidiary of Medco Health Solutions, Inc., a Merck Company.
Laine L, Wogen J, Yu H. Gastrointestinal health care resource utilization with chronic use of COX-2-specific inhibitors versus traditional NSAIDs1 1The Institute for Effectiveness Research, LLC, is a subsidiary of Medco Health Solutions, Inc., a Merck Company. Gastroenterology 2003, 125: 389-395. PMID: 12891540, DOI: 10.1016/s0016-5085(03)00900-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnti-Inflammatory Agents, Non-SteroidalCohort StudiesCost-Benefit AnalysisCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsFemaleGastrointestinal DiseasesHealth ResourcesHumansIsoenzymesLongitudinal StudiesMaleMembrane ProteinsMiddle AgedProstaglandin-Endoperoxide SynthasesRetrospective StudiesConceptsChronic NSAID therapyCoxib therapyNSAID therapyChronic nonsteroidal anti-inflammatory drug (NSAID) therapyNonsteroidal anti-inflammatory drug therapyAnti-inflammatory drug therapyHealth care resource utilizationCOX-2-specific inhibitorsU.S. administrative claims databaseMedco Health SolutionsProportion of patientsAdministrative claims databaseGastrointestinal eventsNewer coxibsInitial prescriptionChronic useClaims databaseDrug therapyClinical trialsDrug costsNew NSAIDClinical practicePatientsTherapyAbstractTextIncidence 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
2001
Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient
Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001, 120: 594-606. PMID: 11179238, DOI: 10.1053/gast.2001.21907.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAnti-Inflammatory Agents, Non-SteroidalCyclooxygenase InhibitorsDigestive SystemEndoscopy, GastrointestinalHumansMiddle AgedRisk FactorsConceptsNonsteroidal anti-inflammatory drugsGI eventsGI diseasePrevention of NSAIDAnti-inflammatory drug useClinical upper GI eventsHistory of ulcerUpper GI eventsHalf of patientsHigh-risk patientsAnti-inflammatory drugsGastrointestinal eventsNSAID doseGastroduodenal injuryNSAID usersClinical featuresGastric erosionsSteroid useCommon causeDrug usePatientsUlcersDiseaseRiskUnited States today
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 ResearchMeSH KeywordsCyclooxygenase InhibitorsDouble-Blind MethodDuodenal UlcerDuodenumEnzyme InhibitorsGastric MucosaHumansIbuprofenIncidenceIntestinal MucosaLactonesPlacebosSulfonesConceptsGastroduodenal 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