2022
Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial
Laine L, DeVault K, Katz P, Mitev S, Lowe J, Hunt B, Spechler S. Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial. Gastroenterology 2022, 164: 61-71. PMID: 36228734, DOI: 10.1053/j.gastro.2022.09.041.Peer-Reviewed Original ResearchConceptsMaintenance of healingProton pump inhibitorsErosive esophagitisSecondary analysisD esophagitisPrimary analysisEnd pointPotassium-competitive acid blocker vonoprazanHeartburn-free daysSevere erosive esophagitisMainstay of treatmentPrimary end pointSecondary end pointsPotent acid inhibitionPPI lansoprazolePump inhibitorsEsophagitisNoninferiority comparisonVonoprazanWeek 2Healing phaseAbstractTextPatientsLansoprazoleSuperiority analysis
2021
Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis
Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal Of Medicine 2021, 385: 1280-1291. PMID: 34587385, DOI: 10.1056/nejmoa2033617.Peer-Reviewed Original ResearchConceptsActive ulcerative colitisMaintenance therapyUlcerative colitisClinical remissionEnd pointClinical responseCohort 2Cohort 1Selective sphingosine-1-phosphate receptor modulatorSphingosine-1-phosphate receptor modulatorsElevated liver aminotransferase levelsKey secondary end pointLiver aminotransferase levelsPlacebo-controlled trialPrimary end pointSecondary end pointsPercentage of patientsDouble-blind mannerInflammatory bowel diseaseSame daily doseIncidence of infectionHistologic end pointsMayo scoreUnderwent randomizationAminotransferase levels
2018
Severity and Outcomes of Upper Gastrointestinal Bleeding With Bloody Vs. Coffee-Grounds Hematemesis
Laine L, Laursen SB, Zakko L, Dalton HR, Ngu JH, Schultz M, Stanley AJ. Severity and Outcomes of Upper Gastrointestinal Bleeding With Bloody Vs. Coffee-Grounds Hematemesis. The American Journal Of Gastroenterology 2018, 113: 358. PMID: 29380820, DOI: 10.1038/ajg.2018.5.Peer-Reviewed Original ResearchMeSH KeywordsAgedBlood PreservationBlood TransfusionEsophageal and Gastric VaricesFemaleGastrointestinal HemorrhageHeart RateHematemesisHemoglobinsHemostasis, EndoscopicHumansMaleMelenaMiddle AgedMortalityProspective StudiesRecurrenceRisk AssessmentSeverity of Illness IndexUpper Gastrointestinal TractConceptsCoffee ground emesisBloody emesisHemostatic interventionUpper gastrointestinal bleedingComposite end pointRisk stratification scoresSystolic blood pressureTiming of endoscopyPredictors of outcomeBeats/minGastrointestinal bleedingConsecutive patientsPrimary outcomeSevere bleedingStratification scoresBlood pressureProspective studyHematemesisMelenaEmesisHigh mortalityEnd pointMortalityOutcomesSeverity
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
2013
Aggressive Hydration With Lactated Ringer's Solution Reduces Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive Hydration With Lactated Ringer's Solution Reduces Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. Clinical Gastroenterology And Hepatology 2013, 12: 303-307.e1. PMID: 23920031, PMCID: PMC3879172, DOI: 10.1016/j.cgh.2013.07.026.Peer-Reviewed Original ResearchConceptsEndoscopic retrograde cholangiopancreatographyPost-ERCP pancreatitisAggressive hydrationStandard hydrationVolume overloadEpigastric painRetrograde cholangiopancreatographyRinger's solutionFirst-time endoscopic retrograde cholangiopancreatographyVisual analogue pain scoreEnd pointPilot studyAggressive intravenous hydrationAnalog pain scoresIncidence of pancreatitisPrimary end pointSecondary end pointsCommon serious complicationLactated Ringer's solutionPeriprocedural hydrationIntravenous hydrationPain scoresSerious complicationsSerum levelsPancreatitis
2010
Clopidogrel with or without Omeprazole in Coronary Artery Disease
Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP. Clopidogrel with or without Omeprazole in Coronary Artery Disease. New England Journal Of Medicine 2010, 363: 1909-1917. PMID: 20925534, DOI: 10.1056/nejmoa1007964.Peer-Reviewed Original ResearchConceptsProton pump inhibitorsDual antiplatelet therapyUpper gastrointestinal bleedingAntiplatelet therapyCardiovascular eventsGastrointestinal bleedingOvert upper gastrointestinal bleedingPrimary cardiovascular end pointEnd pointEvent ratesEfficacy of clopidogrelSymptomatic gastroduodenal ulcersCardiovascular end pointsComposite of deathNonfatal myocardial infarctionSerious adverse eventsCoronary artery diseaseHigh-risk subgroupsRisk of diarrheaCardiovascular causesGastrointestinal complicationsGastrointestinal eventsOccult bleedingAntithrombotic therapyAdverse events
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 approach
2000
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
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 ResearchConceptsGastroduodenal ulcersPrespecified criteriaEffect of rofecoxibPlacebo-controlled trialSecondary end pointsDouble-blind studyGastroduodenal ulcerationGastroduodenal mucosaUlcer incidenceCyclooxygenase-2Side effectsUlcersEnd pointEffective doseRofecoxibWeeksPlaceboPatientsOsteoarthritisIncidenceDoseIbuprofenUlcerationMucosaEndoscopy