2021
Acute gastrointestinal bleeding: proposed study outcomes for new randomised controlled trials
Jensen DM, Barkun A, Cave D, Gralnek IM, Jutabha R, Laine L, Lau JYW, Saltzman JR, Soetikno R, Sung JJY. Acute gastrointestinal bleeding: proposed study outcomes for new randomised controlled trials. Alimentary Pharmacology & Therapeutics 2021, 54: 616-626. PMID: 34288017, PMCID: PMC9385213, DOI: 10.1111/apt.16483.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAcute DiseaseGastrointestinal HemorrhageHospitalizationHumansRandomized Controlled Trials as TopicConceptsAcute gastrointestinal bleedingGastrointestinal bleedingPrimary endpointRed blood cell transfusionRelevant outcomesHealth care resource utilisationLength of hospitalisationSerious adverse eventsTrial of patientsBlood cell transfusionPeer-reviewed fundingMeaningful primary endpointCell transfusionAcute bleedingAdverse eventsComposite outcomeSecondary outcomesFuture RCTsNew RCTsPrimary outcomeHemostatic outcomesClinical trialsCommon causeOutcome measuresGI source
2019
Early Colonoscopy Does Not Improve Outcomes of Patients With Lower Gastrointestinal Bleeding: Systematic Review of Randomized Trials
Tsay C, Shung D, Stemmer Frumento K, Laine L. Early Colonoscopy Does Not Improve Outcomes of Patients With Lower Gastrointestinal Bleeding: Systematic Review of Randomized Trials. Clinical Gastroenterology And Hepatology 2019, 18: 1696-1703.e2. PMID: 31843595, PMCID: PMC7292779, DOI: 10.1016/j.cgh.2019.11.061.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseColonoscopyGastrointestinal HemorrhageHospitalizationHumansRandomized Controlled Trials as TopicConceptsAcute lower gastrointestinal bleedingLower gastrointestinal bleedingRandomized trialsEarly colonoscopyElective colonoscopyGastrointestinal bleedingSecondary outcomesHemostatic interventionEndoscopic interventionDiagnostic yieldSevere acute lower gastrointestinal bleedingSystematic reviewDual independent reviewTiming of colonoscopyOutcomes of patientsHours of presentationRandom-effects modelRecurrent bleedingPrimary outcomeIndex examinationColonoscopy evaluationBias assessmentObservational studyBleedingColonoscopy
2009
Methodology for Randomized Trials of Patients With Nonvariceal Upper Gastrointestinal Bleeding: Recommendations From an International Consensus Conference
Laine L, Spiegel B, Rostom A, Moayyedi P, Kuipers EJ, Bardou M, Sung J, Barkun AN. Methodology for Randomized Trials of Patients With Nonvariceal Upper Gastrointestinal Bleeding: Recommendations From an International Consensus Conference. The American Journal Of Gastroenterology 2009, 105: ajg2009702. PMID: 20029415, DOI: 10.1038/ajg.2009.702.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsNonvariceal upper gastrointestinal bleedingUpper gastrointestinal bleedingPrimary end pointInternational Consensus ConferenceGastrointestinal bleedingRandomized trialsConsensus conferenceEnd pointPrimary assessmentManagement of patientsType of lesionPlacebo/Protocol populationRepeat endoscopyLarge trialsRandomization scheduleInclusion criteriaPatientsSmall studyCurrent standard practiceSubsequent interventionsBleedingLiterature searchSample size calculationConservative approachProton Pump Inhibitor and Clopidogrel Interaction: Fact or Fiction?
Laine L, Hennekens C. Proton Pump Inhibitor and Clopidogrel Interaction: Fact or Fiction? The American Journal Of Gastroenterology 2009, 105: ajg2009638. PMID: 19904241, DOI: 10.1038/ajg.2009.638.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsProton pump inhibitorsClopidogrel usersCV eventsClopidogrel efficacyPump inhibitorsObservational studyPresence of PPIsTrial of omeprazoleHealth care providersCytochrome P450Clopidogrel actionClopidogrel interactionCardiovascular eventsGastrointestinal bleedingRandomized trialsConcomitant useSurrogate markerRecommendations stateClopidogrelCurrent evidenceCYP2C19 functionUS FoodDrug AdministrationPlatelet aggregationActive metabolite
2008
A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures
McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointestinal Endoscopy 2008, 67: 910-923. PMID: 18440381, DOI: 10.1016/j.gie.2007.12.046.Peer-Reviewed Original ResearchMeSH KeywordsConscious SedationDigestive System DiseasesEndoscopy, Digestive SystemHumansRandomized Controlled Trials as TopicConceptsModerate sedationPatient satisfactionAdverse eventsPhysician assessmentSystematic reviewSedation-related complicationsSerious adverse eventsPoor methodologic qualitySuperior patient satisfactionRoutine endoscopic proceduresComputerized bibliographic databasesActive regimenActive regimensLonger sedationRandomized trialsPatient assessmentMethodologic qualityAvailable agentsProcedure timeEndoscopic proceduresLower riskSedationMidazolamRegimensPropofolCOX-2 Selective Inhibitors in the Treatment of Osteoarthritis
Laine L, White WB, Rostom A, Hochberg M. COX-2 Selective Inhibitors in the Treatment of Osteoarthritis. Seminars In Arthritis And Rheumatism 2008, 38: 165-187. PMID: 18177922, DOI: 10.1016/j.semarthrit.2007.10.004.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsTraditional nonsteroidal antiinflammatory drugsNonsteroidal antiinflammatory drugsTreatment of osteoarthritisBlood pressureNonselective nonsteroidal antiinflammatory drugsCyclooxygenase-2 selective inhibitorCOX-2 selective inhibitorsClinical liver injuryHepatic side effectsSignificant renal dysfunctionCongestive heart failureSelective inhibitorAminotransferase elevationClinical hepatotoxicityGastrointestinal complicationsHypertensive patientsRenal dysfunctionUlcer complicationsCardiovascular riskSevere painGastroduodenal ulcersHeart failureLiver injuryOA patientsRandomized trials
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 ratioClinical 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-2A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience
Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience. Pharmacoepidemiology And Drug Safety 2006, 15: 213-220. PMID: 16456879, DOI: 10.1002/pds.1207.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsAlanine TransaminaseAnti-Inflammatory Agents, Non-SteroidalArchivesBenzophenonesBiomarkersBromobenzenesChemical and Drug Induced Liver InjuryHumansLiverPhenylacetatesPropionatesRandomized Controlled Trials as TopicUnited StatesUnited States Food and Drug AdministrationConceptsAcute liver failureNonsteroidal anti-inflammatory drugsSerious hepatotoxicityLiver failureRisk of ALFSystematic reviewDifferent nonsteroidal anti-inflammatory drugsCommon adverse eventsHepatic enzyme elevationFlu-like symptomsDrug-induced hepatotoxicityAnti-inflammatory drugsClinical trial dataSymptomatic hepatitisALT elevationElevated transaminasesAdverse eventsEnzyme elevationDrug withdrawalHepatocellular jaundiceRare caseMedWatch systemDrug AdministrationHepatotoxicityTrial data
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 ResearchMeSH KeywordsAlanine TransaminaseAnti-Inflammatory Agents, Non-SteroidalArthritisAspartate AminotransferasesChemical and Drug Induced Liver InjuryHumansRandomized Controlled Trials as TopicConceptsLiver-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
2004
Treatment of Nonvariceal Upper GI Hemorrhage: What's Happening in the Real World
Laine L. Treatment of Nonvariceal Upper GI Hemorrhage: What's Happening in the Real World. The American Journal Of Gastroenterology 2004, 99: ajg2004246. PMID: 15233661, DOI: 10.1111/j.1572-0241.2004.40252.x.Peer-Reviewed Original ResearchGastrointestinal HemorrhageHemostasis, EndoscopicHumansProton Pump InhibitorsRandomized Controlled Trials as Topic
2001
Therapy for Helicobacter pylori in patients with nonulcer dyspepsia. A meta-analysis of randomized, controlled trials.
Laine L, Schoenfeld P, Fennerty M. Therapy for Helicobacter pylori in patients with nonulcer dyspepsia. A meta-analysis of randomized, controlled trials. Annals Of Internal Medicine 2001, 134: 361-9. PMID: 11242496, DOI: 10.7326/0003-4819-134-5-200103060-00008.Peer-Reviewed Original ResearchMeSH KeywordsAnti-Bacterial AgentsDyspepsiaHelicobacter InfectionsHelicobacter pyloriHumansOdds RatioOrganometallic CompoundsRandomized Controlled Trials as TopicSensitivity and SpecificityTreatment OutcomeConceptsH. pylori eradication therapyNonulcer dyspepsiaPylori eradication therapyEradication therapyControl therapyOdds ratioH. pyloriHelicobacter pyloriDefinition of dyspepsiaDuplicate data extractionEnd of therapyH. pylori infectionAnalysis of trialsPylori infectionCombination therapyMethodologic qualityTreatment successDyspepsiaPersistent infectionReference listsTherapyPatientsStudy designPrimary investigatorPylori
1999
Review article: nonsteroidal anti‐inflammatory drug‐associated gastrointestinal complications—guidelines for prevention and treatment
Schoenfeld, Kimmey, Scheiman, Bjorkman, Laine. Review article: nonsteroidal anti‐inflammatory drug‐associated gastrointestinal complications—guidelines for prevention and treatment. Alimentary Pharmacology & Therapeutics 1999, 13: 1273-1285. PMID: 10540041, DOI: 10.1046/j.1365-2036.1999.00617.x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAnti-Inflammatory Agents, Non-SteroidalGastrointestinal DiseasesHumansPractice Guidelines as TopicRandomized Controlled Trials as TopicConceptsGastrointestinal complicationsPylori infectionSerious gastrointestinal complicationsH. pylori infectionHelicobacter pylori infectionProton pump inhibitorsLowest possible dosagePotential of treatmentNSAID therapyNSAID useAnalgesic therapyCorticosteroid useGastrointestinal bleedingUlcer diseaseAntisecretory agentsPump inhibitorsChronic ingestionPain relieversNSAIDsComplicationsPatientsExact associationPossible dosageRoutine testingPast history
1998
Has the impact of helicobacter pylori therapy on ulcer recurrence in the united states been overstated?
Laine L, Hopkins R, Girardi L. Has the impact of helicobacter pylori therapy on ulcer recurrence in the united states been overstated? The American Journal Of Gastroenterology 1998, 93: 1409. PMID: 9732917, DOI: 10.1111/j.1572-0241.1998.452_a.x.Peer-Reviewed Original ResearchMeSH KeywordsDouble-Blind MethodDuodenal UlcerHelicobacter InfectionsHelicobacter pyloriHumansOdds RatioRandomized Controlled Trials as TopicRecurrenceConceptsH. pylori eradicationH. pylori therapyUlcer recurrencePylori eradicationPylori therapyH. pylori cureNon-NSAID ulcersCompletion of therapyHelicobacter pylori therapyUse of NSAIDsDuodenal ulcer patientsNorth American trialsUlcer recurrence rateHigh methodological qualityEndoscopic biopsy testsReview of abstractsEndoscopic followUlcer patientsDuodenal ulcerRelevant trialsRecurrence rateStudy inclusionOdds ratioCommon odds ratioMethodological quality
1995
Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding. A meta-analysis.
Laine L, Cook D. Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding. A meta-analysis. Annals Of Internal Medicine 1995, 123: 280-7. PMID: 7611595, DOI: 10.7326/0003-4819-123-4-199508150-00007.Peer-Reviewed Original ResearchMeSH KeywordsCause of DeathEndoscopyEsophageal and Gastric VaricesGastrointestinal HemorrhageHumansLigationOdds RatioRandomized Controlled Trials as TopicRecurrenceSclerotherapyConceptsEsophageal variceal bleedingTreatment of patientsEndoscopic ligationVariceal bleedingEsophageal varicesEndoscopic treatmentDuplicate data abstractionDuplicate independent reviewEndoscopic treatment sessionsRate of deathRelevant primary articlesReview of citationsVariceal obliterationBacterial peritonitisLigation therapyPulmonary infectionEsophageal strictureMethodologic qualitySclerotherapyMortality rateTreatment sessionsPatientsRelevant articlesPrimary investigatorUnpublished studiesLigation: Endoscopic treatment of choice for patients with bleeding esophageal varices?
Laine L. Ligation: Endoscopic treatment of choice for patients with bleeding esophageal varices? Hepatology 1995, 22: 663-665. PMID: 7635437, DOI: 10.1002/hep.1840220242.Commentaries, Editorials and LettersEsophageal and Gastric VaricesEsophagoscopyGastrointestinal HemorrhageHumansLigationRandomized Controlled Trials as Topic
1990
Acute variceal bleeding: Still searching for the right treatment
Silvain C, Fort E, Ingrand P, Beauchant M, Valenzuela J, Schubert T, Posillico J, Laine L. Acute variceal bleeding: Still searching for the right treatment. Hepatology 1990, 12: 625-626. PMID: 1976106, DOI: 10.1002/hep.1840120335.Commentaries, Editorials and LettersAcute DiseaseEsophageal and Gastric VaricesGastrointestinal HemorrhageHumansRandomized Controlled Trials as TopicSomatostatin