2020
Long-term Outcomes Following Multiply Recurrent Clostridioides difficile Infection and Fecal Microbiota Transplantation
Dawwas GK, Brensinger CM, Vajravelu RK, Wu Q, Kelly CR, Laine L, Wu GD, Lewis JD. Long-term Outcomes Following Multiply Recurrent Clostridioides difficile Infection and Fecal Microbiota Transplantation. Clinical Gastroenterology And Hepatology 2020, 20: 806-816.e6. PMID: 33307184, PMCID: PMC8184854, DOI: 10.1016/j.cgh.2020.12.004.Peer-Reviewed Original ResearchConceptsFecal microbiota transplantationIrritable bowel syndromeImmune-mediated diseasesBowel syndromeMyocardial infarctionMicrobiota transplantationRecurrent Clostridioides difficile infectionRecurrent Clostridioides difficileRetrospective cohort studyImmune-mediated conditionsInflammatory bowel diseaseInflammatory bowel syndromeCommercial claims databaseLong-term outcomesClostridioides difficile infectionCohort studyBowel diseaseMicrobiota disturbanceRheumatoid arthritisClaims databaseDifficile infectionHigh riskHigh incidenceGut microbiotaSignificant association
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 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
2005
Nonsteroidal Anti-Inflammatory Drugs and Hepatic Toxicity: A Systematic Review of Randomized Controlled Trials in Arthritis Patients
Rostom A, Goldkind L, Laine L. Nonsteroidal Anti-Inflammatory Drugs and Hepatic Toxicity: A Systematic Review of Randomized Controlled Trials in Arthritis Patients. Clinical Gastroenterology And Hepatology 2005, 3: 489-498. PMID: 15880319, DOI: 10.1016/s1542-3565(04)00777-3.Peer-Reviewed Original ResearchConceptsLiver-related deathLiver-related hospitalizationsSerious adverse eventsAnti-inflammatory drugsAminotransferase elevationAdverse eventsSide effectsNonsteroidal anti-inflammatory drugsTrials of diclofenacHepatic side effectsProportion of patientsClinical side effectsRandomized Controlled TrialsBibliographic databases MEDLINEHigh rateArthritis patientsControlled TrialsRheumatoid arthritisHepatic toxicityInclusion criteriaDatabases MEDLINENSAIDsDrug AdministrationSystematic reviewToxicity outcomes
2003
Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo
Hawkey C, 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. European Journal Of Gastroenterology & Hepatology 2003, 15: 835. DOI: 10.1097/00042737-200307000-00021.Peer-Reviewed Original ResearchIncidence 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 ratePatientsGastrointestinal (GI) co-therapy, procedures, and hospitalizations in a GI outcomes study of rofecoxib vs. naproxen in rheumatoid arthritis
Laine L, Bombardier C, Reicin A, Hawkey C, Watson D, Ramey D, Brett C. Gastrointestinal (GI) co-therapy, procedures, and hospitalizations in a GI outcomes study of rofecoxib vs. naproxen in rheumatoid arthritis. The American Journal Of Gastroenterology 2000, 95: 2633. DOI: 10.1111/j.1572-0241.2000.03124.x.Peer-Reviewed Original Research