2024
Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial
Laine L, Spechler S, Yadlapati R, Schnoll-Sussman F, Smith N, Leifke E, Harris T, Hunt B, Fass R, Katz P. Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial. Clinical Gastroenterology And Hepatology 2024, 22: 2211-2220.e10. PMID: 38750866, DOI: 10.1016/j.cgh.2024.05.004.Peer-Reviewed Original ResearchNon-erosive reflux diseaseHeartburn-free daysErosive esophagitisReflux diseaseRandomized trialsActive-treatment extensionRandomized to placeboPotassium-competitive acid blockerPlacebo-controlled periodDays of therapyPercentage of subjectsPrimary endpointPercentage of daysHeartburn symptomsPlaceboVonoprazanAcid blockerNighttime heartburnDay 1Randomized subjectsDocumented efficacyStudy armsDay 2Adult subjectsExtension periodMo1281 COMPARISON OF LOCAL INVESTIGATOR-REPORTED VS CENTRALLY ADJUDICATED LOS ANGELES GRADES OF EROSIVE ESOPHAGITIS IN PATIENTS SCREENED FOR PARTICIPATION IN A RANDOMIZED TRIAL
Spechler S, Laine L, Devault K, Smith N, Leifke E, Nabulsi A, Hunt B, Katz P. Mo1281 COMPARISON OF LOCAL INVESTIGATOR-REPORTED VS CENTRALLY ADJUDICATED LOS ANGELES GRADES OF EROSIVE ESOPHAGITIS IN PATIENTS SCREENED FOR PARTICIPATION IN A RANDOMIZED TRIAL. Gastroenterology 2024, 166: s-1011-s-1012. DOI: 10.1016/s0016-5085(24)02800-2.Peer-Reviewed Original Research
2022
Association of Antisecretory Drugs with Upper Gastrointestinal Bleeding in Patients Using Oral Anticoagulants: A Systematic Review and Meta-Analysis
Kurlander JE, Barnes GD, Fisher A, Gonzalez JJ, Helminski D, Saini SD, Sengupta N, Yang YX, Scheiman J, Laine L. Association of Antisecretory Drugs with Upper Gastrointestinal Bleeding in Patients Using Oral Anticoagulants: A Systematic Review and Meta-Analysis. The American Journal Of Medicine 2022, 135: 1231-1243.e8. PMID: 35679879, PMCID: PMC10031639, DOI: 10.1016/j.amjmed.2022.05.031.Peer-Reviewed Original ResearchConceptsUpper gastrointestinal bleedingProton pump inhibitorsGastrointestinal bleedingH2-receptor antagonistsObservational studyOral anticoagulantsAntisecretory drugsRelative riskLower riskNonsteroidal anti-inflammatory drug useSystematic reviewAnti-inflammatory drug useOvert upper gastrointestinal bleedingLow statistical heterogeneitySingle observational studyGreater treatment effectRandom-effects modelWeb of ScienceConcomitant aspirinRandomized trialsCochrane LibraryPump inhibitorsBias assessmentStatistical heterogeneityBleeding
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 ResearchConceptsAcute 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
2017
Early Aggressive Hydration Hastens Clinical Improvement in Mild Acute Pancreatitis
Buxbaum JL, Quezada M, Da B, Jani N, Lane C, Mwengela D, Kelly T, Jhun P, Dhanireddy K, Laine L. Early Aggressive Hydration Hastens Clinical Improvement in Mild Acute Pancreatitis. The American Journal Of Gastroenterology 2017, 112: 797. PMID: 28266591, DOI: 10.1038/ajg.2017.40.Peer-Reviewed Original ResearchConceptsSystemic inflammatory response syndromeMild acute pancreatitisBlood urea nitrogenAggressive intravenous hydrationClinical improvementStandard hydrationAcute pancreatitisIntravenous hydrationPersistent systemic inflammatory response syndromeClear liquid dietInflammatory response syndromeCox regression analysisAcute pancreatitis treatmentLactated Ringer's solutionAggressive hydrationEpigastric painImproved painOral dietPrimary endpointInitial managementOrgan failureResponse syndromeRandomized trialsVolume overloadMean age
2016
Randomized Trial of Endoscopist-Controlled vs. Assistant-Controlled Wire-Guided Cannulation of the Bile Duct
Buxbaum J, Leonor P, Tung J, Lane C, Sahakian A, Laine L. Randomized Trial of Endoscopist-Controlled vs. Assistant-Controlled Wire-Guided Cannulation of the Bile Duct. The American Journal Of Gastroenterology 2016, 111: 1841. PMID: 27377519, DOI: 10.1038/ajg.2016.268.Peer-Reviewed Original ResearchMeSH KeywordsAdultBile DuctsCatheterizationCholangiopancreatography, Endoscopic RetrogradeCholangitisEarly Termination of Clinical TrialsFemaleGastroenterologistsHemorrhageHumansIntraoperative ComplicationsLogistic ModelsMaleMiddle AgedMultivariate AnalysisNursesPancreatitisPatient SafetyPostoperative ComplicationsPostoperative HemorrhageConceptsBile duct cannulationEndoscopic retrograde cholangiopancreatographySafety end pointDuct cannulationBiliary cannulationInterim analysisWire guidanceComposite safety end pointComplications of ERCPEnd pointPrimary efficacy outcomePost-ERCP pancreatitisSuccessful biliary cannulationSignificant differencesEfficacy outcomesRandomized trialsBile ductRetrograde cholangiopancreatographyCannulation attemptsCannulationPatientsSphincterotomePancreatitisSignificant increaseLower rates
2015
Treatment of Refractory Gastrointestinal Strictures With Mitomycin C
Rustagi T, Aslanian HR, Laine L. Treatment of Refractory Gastrointestinal Strictures With Mitomycin C. Journal Of Clinical Gastroenterology 2015, 49: 837-847. PMID: 25626632, DOI: 10.1097/mcg.0000000000000295.Peer-Reviewed Original ResearchConceptsMitomycin C applicationMitomycin CGastrointestinal stricturesSystematic reviewLimited therapeutic interventionsAdditional randomized trialsLarge prospective studiesDifficult management problemSearch of MEDLINEBenign gastrointestinal stricturesTitles/abstractsCutaneous sclerosisAdverse eventsPartial responseComplete responseCaustic injuryRandomized trialsRefractory stricturesEsophageal strictureProspective studyEmbase databasesCommon siteEffective therapyInclusion criteriaOptimal dose
2012
4-Liter Split-Dose Polyethylene Glycol Is Superior to Other Bowel Preparations, Based on Systematic Review and Meta-analysis
Enestvedt BK, Tofani C, Laine LA, Tierney A, Fennerty MB. 4-Liter Split-Dose Polyethylene Glycol Is Superior to Other Bowel Preparations, Based on Systematic Review and Meta-analysis. Clinical Gastroenterology And Hepatology 2012, 10: 1225-1231. PMID: 22940741, DOI: 10.1016/j.cgh.2012.08.029.Peer-Reviewed Original ResearchConceptsSplit-dose PEGBowel preparation methodsBowel preparation qualityAdjunct therapyRandomized trialsBowel cleansingBowel preparationOdds ratioPooled estimatesSplit dosePublication biasPreparation qualityDose polyethylene glycolSplit-dose regimensCochrane Central RegisterMajor conference proceedingsSignificant heterogeneitySignificant publication biasLow-volume regimensRandom-effects modelSame preparationAbdominal crampingCentral RegisterPatient demographicsControlled TrialsCorrigendum: Double-Blind Randomized Trials of Single-Tablet Ibuprofen/High-Dose Famotidine vs. Ibuprofen Alone for Reduction of Gastric and Duodenal Ulcers
Laine L, Kivitz A, Bello A, Grahn A, Schiff M, Taha A. Corrigendum: Double-Blind Randomized Trials of Single-Tablet Ibuprofen/High-Dose Famotidine vs. Ibuprofen Alone for Reduction of Gastric and Duodenal Ulcers. The American Journal Of Gastroenterology 2012, 107: 1272. DOI: 10.1038/ajg.2012.244.Peer-Reviewed Original Research
2011
Double-Blind Randomized Trials of Single-Tablet Ibuprofen/High-Dose Famotidine vs. Ibuprofen Alone for Reduction of Gastric and Duodenal Ulcers
Laine L, Kivitz AJ, Bello AE, Grahn AY, Schiff MH, Taha AS. Double-Blind Randomized Trials of Single-Tablet Ibuprofen/High-Dose Famotidine vs. Ibuprofen Alone for Reduction of Gastric and Duodenal Ulcers. The American Journal Of Gastroenterology 2011, 107: ajg2011443. PMID: 22186979, PMCID: PMC3321505, DOI: 10.1038/ajg.2011.443.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsChi-Square DistributionDouble-Blind MethodDrug CombinationsDuodenal UlcerEndoscopy, GastrointestinalFamotidineFemaleHumansIbuprofenMaleMiddle AgedProportional Hazards ModelsRisk FactorsStomach UlcerTreatment OutcomeConceptsPrimary end point analysisNon-steroidal anti-inflammatory drugsUpper GI ulcersDuodenal ulcerGI ulcersGastric ulcerEnd-point analysisDaily non-steroidal anti-inflammatory drugsH. pylori stool testDouble-blind randomized trialsMultiple potential risk factorsReduction of gastricSingle-tablet combinationUpper gastrointestinal ulcersDouble-blind trialProportional hazards analysisPotential risk factorsAnti-inflammatory drugsBaseline endoscopyREDUCE studyStudy endoscopyTablets thriceUlcer complicationsStool testRandomized trials
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 modelRandomized Trial of Urgent vs. Elective Colonoscopy in Patients Hospitalized With Lower GI Bleeding
Laine L, Shah A. Randomized Trial of Urgent vs. Elective Colonoscopy in Patients Hospitalized With Lower GI Bleeding. The American Journal Of Gastroenterology 2010, 105: 2636. PMID: 20648004, DOI: 10.1038/ajg.2010.277.Peer-Reviewed Original ResearchConceptsLower GI bleedingElective colonoscopyUpper endoscopyUrgent colonoscopyGI bleedingBlood pressureHeart rateUpper gastrointestinal sourceUpper GI sourceUrgent upper endoscopyPrimary end pointDuration of hospitalizationSystolic blood pressureUnits of bloodEligible patientsUrgent groupElective groupHospital daysOrthostatic changesBlood transfusionClinical outcomesRandomized trialsHospital chargesVs. 5Gastrointestinal sourceDoes Capsule Endoscopy Improve Outcomes in Obscure Gastrointestinal Bleeding? Randomized Trial Versus Dedicated Small Bowel Radiography
Laine L, Sahota A, Shah A. Does Capsule Endoscopy Improve Outcomes in Obscure Gastrointestinal Bleeding? Randomized Trial Versus Dedicated Small Bowel Radiography. Gastroenterology 2010, 138: 1673-1680.e1. PMID: 20138043, DOI: 10.1053/j.gastro.2010.01.047.Peer-Reviewed Original ResearchConceptsObscure GI bleedingObscure gastrointestinal bleedingDiagnostic yieldGI bleedingGastrointestinal bleedingTherapeutic interventionsCapsule endoscopyNegative upper endoscopySubsequent blood transfusionSmall bowel radiographyOccult bleedingPrimary endpointSubsequent hospitalizationMost patientsUpper endoscopyBlood transfusionHemoglobin levelsRandomized trialsVs 5Improved outcomesBleedingContrast radiographyPatientsEndoscopyAbstractText
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
Endoscopic Therapy for Bleeding Ulcers: An Evidence-Based Approach Based on Meta-Analyses of Randomized Controlled Trials
Laine L, McQuaid KR. Endoscopic Therapy for Bleeding Ulcers: An Evidence-Based Approach Based on Meta-Analyses of Randomized Controlled Trials. Clinical Gastroenterology And Hepatology 2008, 7: 33-47. PMID: 18986845, DOI: 10.1016/j.cgh.2008.08.016.Peer-Reviewed Original ResearchConceptsEndoscopic therapyProton pump inhibitorsActive bleedingVisible vesselPump inhibitorsIntravenous proton pump inhibitorsAppropriate endoscopic treatmentNonbleeding visible vesselPrimary end pointSecond-look endoscopyEndoscopic hemostatic therapyRandomized Controlled TrialsEvidence-based approachPlacebo/Further bleedingHemostatic therapyInjection therapyControlled TrialsEndoscopic treatmentRandomized trialsBleeding ulcersSclerosant therapyReceptor antagonistBibliographic database searchBleedingA 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 ResearchConceptsModerate 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
THE MEDAL PROGRAM DESIGN: THREE RANDOMIZED TRIALS IN 34,701 PATIENTS WITH OA OR RA TO EVALUATE CARDIOVASCULAR SAFETY OF ETORICOXIB VERSUS DICLOFENAC
Bolognese J, Cannon C, Curtis S, Laine L. THE MEDAL PROGRAM DESIGN: THREE RANDOMIZED TRIALS IN 34,701 PATIENTS WITH OA OR RA TO EVALUATE CARDIOVASCULAR SAFETY OF ETORICOXIB VERSUS DICLOFENAC. JCR Journal Of Clinical Rheumatology 2006, 12: s85-s86. DOI: 10.1097/01.rhu.0000233330.39079.13.Peer-Reviewed Original Research
2000
Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials
Laine L, Fennerty M, Osato M, Sugg J, Suchower L, Probst P, Levine J. Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. The American Journal Of Gastroenterology 2000, 95: ajg20001583. PMID: 11151867, DOI: 10.1111/j.1572-0241.2000.03349.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAmoxicillinClarithromycinDouble-Blind MethodDrug Administration ScheduleDrug Resistance, MicrobialDrug Therapy, CombinationDuodenal UlcerEsomeprazoleFemaleHelicobacter InfectionsHelicobacter pyloriHumansMaleMiddle AgedPenicillin ResistancePenicillinsProspective StudiesProtein Synthesis InhibitorsProton Pump InhibitorsConceptsEradication rateClarithromycin resistanceDaily esomeprazoleTriple therapyDuodenal ulcerProton pump inhibitor-based triple therapyTen-day triple therapyHelicobacter pylori eradication therapyEmergent resistanceH. pylori-positive patientsInhibitor-based triple therapyDouble-blind trialTreat eradication ratesCompletion of therapyPylori eradication therapyPylori-positive patientsSeparate randomized trialsAntibiotic resistanceDaily amoxicillinUS multicenterEradication therapyRandomized trialsHelicobacter pyloriTherapyEsomeprazole