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 period
2022
Deprescription of aspirin for primary prevention is uncommon at discharge in hospitalised patients with gastrointestinal bleeding
Li D, Ong S, Hughes M, Hung K, Agarwal R, Alexis J, Damianos J, Sharma S, Pires J, Nanna M, Laine L. Deprescription of aspirin for primary prevention is uncommon at discharge in hospitalised patients with gastrointestinal bleeding. Alimentary Pharmacology & Therapeutics 2022, 57: 94-102. PMID: 36394111, DOI: 10.1111/apt.17278.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsGastrointestinal bleedingPrimary preventionCardiovascular eventsRisk of MACEYale-New Haven HospitalPrimary cardiovascular preventionAdverse cardiovascular eventsKaplan-Meier curvesLong-term outcomesRisk-benefit ratioLog-rank testAspirin 81Hospitalised patientsPrimary endpointSecondary endpointsCardiovascular preventionSubsequent hospitalisationMedian ageDeprescriptionHigh riskAspirinHospitalisationPatientsPrevention
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 StatementsConceptsAcute 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
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 ageContinued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial
Sachar H, Pichetshote N, Nandigam K, Vaidya K, Laine L. Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial. Gastrointestinal Endoscopy 2017, 87: 1297-1303. PMID: 28159539, PMCID: PMC5537051, DOI: 10.1016/j.gie.2017.01.028.Peer-Reviewed Original ResearchConceptsDouble-blind trialAdequate sedationStudy medicationModerate sedationAlertness/Sedation scoreAdequacy of sedationStudy medication dosePsychiatric medication useModified Observer's AssessmentMOAA/SAdditional medicationElective colonoscopyPrimary endpointOpioid combinationsOpioid useMedication useMore patientsSedation scoreSuch patientsMedication doseUsual dosesBenzodiazepine useCurrent guidelinesSedate patientsSedation
2016
Randomized trial of 1‐week versus 2‐week intervals for endoscopic ligation in the treatment of patients with esophageal variceal bleeding
Sheibani S, Khemichian S, Kim JJ, Hou L, Yan AW, Buxbaum J, Dara L, Laine L. Randomized trial of 1‐week versus 2‐week intervals for endoscopic ligation in the treatment of patients with esophageal variceal bleeding. Hepatology 2016, 64: 549-555. PMID: 27082942, PMCID: PMC4956532, DOI: 10.1002/hep.28597.Peer-Reviewed Original ResearchConceptsEsophageal variceal bleedingVariceal bleedingVariceal eradicationAcute esophageal variceal bleedingBeta-blocker therapyProportion of patientsTreatment of patientsNumber of endoscopiesMean numberLigation sessionsChest painPrimary endpointAdverse eventsClinical outcomesEndoscopic ligationLast endoscopyPhysician preferencePatientsBleedingSuccessful ligationEndoscopyConfidence intervalsEradicationLigationWeeks
2014
Lower Yield of Endoscopic Ultrasound-Guided Fine-Needle Aspiration in Patients with Pancreatic Head Mass with a Biliary Stent
Kim JJ, Walia S, Lee SH, Patel B, Vetsa M, Zhao Y, Srikureja W, Laine L. Lower Yield of Endoscopic Ultrasound-Guided Fine-Needle Aspiration in Patients with Pancreatic Head Mass with a Biliary Stent. Digestive Diseases And Sciences 2014, 60: 543-549. PMID: 25245115, DOI: 10.1007/s10620-014-3367-0.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAgedCholangiopancreatography, Endoscopic RetrogradeEndoscopic Ultrasound-Guided Fine Needle AspirationFemaleHumansJaundice, ObstructiveMaleMiddle AgedMultivariate AnalysisOdds RatioPalliative CarePancreatic NeoplasmsPredictive Value of TestsRetrospective StudiesRisk FactorsStentsTime FactorsTreatment OutcomeConceptsEndoscopic ultrasound-guided fine-needle aspirationEndoscopic retrograde cholangiopancreatographyBiliary stentsFine-needle aspirationJaundiced patientsPancreatic cancerFinal diagnosisHistologic diagnosisPancreatic massOnsite cytopathologistUltrasound-guided fine-needle aspirationPancreatic head massHistologic accuracyResultsMean ageMethodsConsecutive patientsPrimary endpointRadiologic evaluationRetrograde cholangiopancreatographyCore biopsyEndoscopic ultrasoundPatientsMultivariate analysisStentsMalignancyDiagnosis
2010
Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate‐to‐severe erosive oesophagitis – the results of two double‐blind studies
Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate‐to‐severe erosive oesophagitis – the results of two double‐blind studies. Alimentary Pharmacology & Therapeutics 2010, 33: 203-212. PMID: 21114792, DOI: 10.1111/j.1365-2036.2010.04516.x.Peer-Reviewed Original ResearchConceptsHeartburn resolutionErosive oesophagitisExtended releaseLA grade CSevere erosive oesophagitisDouble-blind trialDouble-blind studyPossibility of benefitCurrent PPIsD oesophagitisSevere oesophagitisGERD patientsSecondary endpointsPrimary endpointSymptomatic resolutionAcid suppressionSubgroup analysisDrug exposureClinical trialsOesophagitisGrade DGrade CFurther evaluationEsomeprazoleAcid inhibitionDoes 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
Cardiovascular 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 duration