2019
Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn
Spechler SJ, Hunter JG, Jones KM, Lee R, Smith BR, Mashimo H, Sanchez VM, Dunbar KB, Pham TH, Murthy UK, Kim T, Jackson CS, Wallen JM, von Rosenvinge EC, Pearl JP, Laine L, Kim AW, Kaz AM, Tatum RP, Gellad ZF, Lagoo-Deenadayalan S, Rubenstein JH, Ghaferi AA, Lo WK, Fernando RS, Chan BS, Paski SC, Provenzale D, Castell DO, Lieberman D, Souza RF, Chey WD, Warren SR, Davis-Karim A, Melton SD, Genta RM, Serpi T, Biswas K, Huang GD. Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn. New England Journal Of Medicine 2019, 381: 1513-1523. PMID: 31618539, DOI: 10.1056/nejmoa1811424.Peer-Reviewed Original ResearchConceptsPPI-refractory heartburnActive medical treatmentMedical treatmentTreatment successGastroenterology clinicSurgical treatmentProton pump inhibitor treatmentMultichannel intraluminal impedance-pH monitoringMedical groupGastroesophageal reflux diseaseFrequent clinical problemMinority of patientsHealth Related QualityImpedance-pH monitoringMultiple potential causesFunctional heartburnRefractory heartburnVisceral hypersensitivityAntireflux surgeryGastroesophageal refluxReflux diseaseUnderwent endoscopyEsophageal manometryPrimary outcomeEsophageal biopsies
2016
Efficacy and Safety of Proton-Pump Inhibitors in High-Risk Cardiovascular Subsets of the COGENT Trial
Vaduganathan M, Cannon CP, Cryer BL, Liu Y, Hsieh WH, Doros G, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Bhatt DL, Investigators C. Efficacy and Safety of Proton-Pump Inhibitors in High-Risk Cardiovascular Subsets of the COGENT Trial. The American Journal Of Medicine 2016, 129: 1002-1005. PMID: 27143321, DOI: 10.1016/j.amjmed.2016.03.042.Peer-Reviewed Original ResearchConceptsDual antiplatelet therapyProton pump inhibitorsAcute coronary syndromePercutaneous coronary interventionCardiovascular eventsCoronary syndromeCoronary interventionGastrointestinal eventsPercutaneous coronary intervention-treated patientsSafety of PPIsUnadjusted Cox proportional hazards modelCox proportional hazards modelDays of randomizationMajor cardiovascular eventsComposite cardiovascular eventsSubset of patientsSafety of omeprazoleProportional hazards modelGastroprotective strategiesMedian followPPI therapyAntiplatelet therapyFrequent indicationHazards modelPatientsProton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy
Vaduganathan M, Bhatt DL, Cryer BL, Liu Y, Hsieh WH, Doros G, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Cannon CP, Investigators C. Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy. Journal Of The American College Of Cardiology 2016, 67: 1661-1671. PMID: 27012778, DOI: 10.1016/j.jacc.2015.12.068.Peer-Reviewed Original ResearchMeSH KeywordsAgedAspirinClopidogrelDose-Response Relationship, DrugDrug Therapy, CombinationDyspepsiaFemaleGastrointestinal HemorrhageHumansIntestinal ObstructionIntestinal PerforationMaleMiddle AgedMyocardial InfarctionMyocardial RevascularizationOmeprazolePainPeptic UlcerPlatelet Aggregation InhibitorsProspective StudiesProton Pump InhibitorsStrokeTiclopidineConceptsDual antiplatelet therapyLow-dose aspirinProton pump inhibitorsMajor adverse cardiac eventsAdverse cardiac eventsPPI therapyAntiplatelet therapyAspirin usersGastrointestinal eventsCardiac eventsGI eventsMeier estimatesArtery diseaseCardiovascular endpointsLow-dose aspirin usersPrimary cardiovascular endpointUpper GI eventsHigh-dose aspirinPeripheral artery diseasePercutaneous coronary interventionCoronary artery diseaseHigh rateAspirin groupBlinded gastroenterologistsAspirin dose
2015
The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial
Vardi M, Cryer BL, Cohen M, Lanas A, Schnitzer TJ, Lapuerta P, Goldsmith MA, Laine L, Doros G, Liu Y, McIntosh AI, Cannon CP, Bhatt DL. The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial. Alimentary Pharmacology & Therapeutics 2015, 42: 365-374. PMID: 26032114, PMCID: PMC4494867, DOI: 10.1111/apt.13260.Peer-Reviewed Original ResearchConceptsDual anti-platelet therapyAnti-platelet therapyGastrointestinal Event TrialLow-dose aspirinNonpain symptomsEvents trialPatient-reported outcome dataPercent of patientsPatient-reported symptomsPatient-reported outcomesPatient-reported severityOmeprazole groupProphylactic omeprazoleCardiovascular safetyGastrointestinal bleedingPain intensityClinical eventsOmeprazole useClinical significanceOutcome dataAssessment QuestionnaireClopidogrelDyspepsiaTherapyPatients
2011
Proton Pump Inhibitor Co-therapy With Clopidogrel: Is There GI Benefit or Cardiovascular Harm?
Laine L. Proton Pump Inhibitor Co-therapy With Clopidogrel: Is There GI Benefit or Cardiovascular Harm? Gastroenterology 2011, 140: 769-772.e2. PMID: 21266209, DOI: 10.1053/j.gastro.2011.01.024.Commentaries, Editorials and Letters
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
Proton 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
2006
Effect of frequent dosing of an oral proton pump inhibitor on intragastric pH
PAIS SA, NATHWANI RA, DHAR V, NOWAIN A, LAINE L. Effect of frequent dosing of an oral proton pump inhibitor on intragastric pH. Alimentary Pharmacology & Therapeutics 2006, 23: 1607-1613. PMID: 16696810, DOI: 10.1111/j.1365-2036.2006.02933.x.Peer-Reviewed Original ResearchConceptsProton pump inhibitorsPump inhibitorsOral proton pump inhibitorsDoses of lansoprazoleFrequent oral dosingLansoprazole plasma concentrationHelicobacter pylori statusCYP2C19 statusOral lansoprazolePylori statusOvernight fastOral dosingPlasma concentrationsFrequent dosingHealthy volunteersClot formationTime pointsLansoprazoleMean proportionDosingInhibitorsSubjectsStatusPatientsPeriod
2005
Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients
Conrad SA, Gabrielli A, Margolis B, Quartin A, Hata JS, Frank WO, Bagin RG, Rock JA, Hepburn B, Laine L. Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients. Critical Care Medicine 2005, 33: 760-765. PMID: 15818102, DOI: 10.1097/01.ccm.0000157751.92249.32.Peer-Reviewed Original ResearchConceptsUpper gastrointestinal bleedingSignificant upper gastrointestinal bleedingGastrointestinal bleedingIll patientsIntravenous cimetidineOmeprazole suspensionMedian gastricChronic Health Evaluation (APACHE II) scoreTrial daysOral suspensionCimetidine treatment groupsDouble-blind trialPrimary end pointDouble-blind comparisonIntensive care unitAdditional risk factorsAcute PhysiologyProtocol populationCimetidine treatmentMedication dosesOrogastric tubeSignificant bleedingCare unitMechanical ventilationGastric aspirates
2003
Bismuth-Based Quadruple Therapy Using a Single Capsule of Bismuth Biskalcitrate, Metronidazole, and Tetracycline Given With Omeprazole Versus Omeprazole, Amoxicillin, and Clarithromycin for Eradication of Helicobacter pylori in Duodenal Ulcer Patients: A Prospective, Randomized, Multicenter, North American Trial
Laine L, Hunt R, El-Zimaity H, Nguyen B, Osato M, Spénard J. Bismuth-Based Quadruple Therapy Using a Single Capsule of Bismuth Biskalcitrate, Metronidazole, and Tetracycline Given With Omeprazole Versus Omeprazole, Amoxicillin, and Clarithromycin for Eradication of Helicobacter pylori in Duodenal Ulcer Patients: A Prospective, Randomized, Multicenter, North American Trial. The American Journal Of Gastroenterology 2003, 98: ajg2003137. PMID: 12650788, DOI: 10.1111/j.1572-0241.2003.t01-1-07288.x.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAmoxicillinAnti-Bacterial AgentsAnti-Ulcer AgentsCapsulesDrug Administration ScheduleDrug CombinationsDrug Therapy, CombinationDuodenal UlcerFemaleHelicobacter InfectionsHelicobacter pyloriHumansMaleMetronidazoleMiddle AgedNorth AmericaOmeprazoleOrganometallic CompoundsTetracyclineTreatment OutcomeConceptsUrea breath testQuadruple therapyDuodenal ulcerBreath testNegative urea breath testTreat eradication ratesH. pylori eradicationActive duodenal ulcerDuodenal ulcer patientsNorth American trialsClarithromycin-resistant strainsActive-controlled trialHelicobacter pylori infectionTreatment of patientsMetronidazole-resistant strainsCapsules q.OAC patientsOAC regimenEradication ratePylori eradicationTriple therapyAdverse eventsUlcer patientsPylori infectionMetronidazole resistance
2002
Helicobacter pylori eradication does not worsen quality of life related to reflux symptoms: a prospective trial
Laine L, Dhir V. Helicobacter pylori eradication does not worsen quality of life related to reflux symptoms: a prospective trial. Alimentary Pharmacology & Therapeutics 2002, 16: 1143-1148. PMID: 12030957, DOI: 10.1046/j.1365-2036.2002.01267.x.Peer-Reviewed Original ResearchMeSH Keywords2-PyridinylmethylsulfinylbenzimidazolesAdultAmoxicillinAnti-Bacterial AgentsAnti-Ulcer AgentsBreath TestsClarithromycinDrug Therapy, CombinationDyspepsiaFemaleGastroesophageal RefluxHelicobacter InfectionsHumansLansoprazoleMaleMiddle AgedOmeprazolePenicillinsProspective StudiesQuality of LifeUreaConceptsGastro-oesophageal reflux diseaseQuality of lifeH. pylori therapyPylori therapyReflux diseaseH. pyloriSymptomatic gastro-oesophageal reflux diseaseHelicobacter pylori eradicationHelicobacter pylori therapyPopulation of patientsEnd of therapyUrea breath testReflux symptomsPylori eradicationTriple therapyProspective trialEndoscopic biopsyPrimary complaintProspective studyLife QuestionnaireBreath testPatientsTherapyMonthsSymptoms
2000
Endoscopic biopsy requirements for post-treatment diagnosis of Helicobacter pylori
Laine L, Sugg J, Suchower L, Neil G. Endoscopic biopsy requirements for post-treatment diagnosis of Helicobacter pylori. Gastrointestinal Endoscopy 2000, 51: 664-669. PMID: 10840297, DOI: 10.1067/mge.2000.105776.Peer-Reviewed Original ResearchConceptsTriple therapyH pylori infectionBody biopsyAntral biopsiesHistologic examinationPylori infectionBiopsy testsDiagnostic yieldProton pump inhibitor-based triple therapyMulticenter double-blind trialInhibitor-based triple therapyDouble-blind trialPost-treatment sensitivityTriple therapy groupDual antibiotic therapyH pylori statusRapid urease testEndoscopic biopsy testsPost-treatment diagnosisHelicobacter pylori diagnosisPretreatment sensitivityEradication therapyUntreated patientsAntibiotic therapyDual therapy
1999
Once-daily therapy for H. pylori infection: a randomized comparison of four regimens
Laine L, Estrada R, Trujillo M, Cheybani K, Yeramian P, Smith S, Neil G. Once-daily therapy for H. pylori infection: a randomized comparison of four regimens. The American Journal Of Gastroenterology 1999, 94: 962. PMID: 10201465, DOI: 10.1111/j.1572-0241.1999.995_r.x.Peer-Reviewed Original ResearchConceptsH. pylori infectionEradication ratePylori infectionExtended-release formulationDaily therapyBreath testDaily triple therapyHigh-dose omeprazoleTreat eradication ratesCompletion of therapyHelicobacter pylori infectionRepeat breath testStudy medicationTriple therapyEndoscopic biopsyRandomized comparisonLack of complianceTherapyPilot studyInfectionFurther studiesClarithromycinOmamDaysSubjects
1998
Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials
Laine L, Suchower L, Frantz J, Connors A, Neil G. Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials. The American Journal Of Gastroenterology 1998, 93: ajg1998488. PMID: 9820381, DOI: 10.1111/j.1572-0241.1998.00602.x.Peer-Reviewed Original ResearchConceptsDuodenal ulcer diseaseTriple therapyEradication rateUlcer diseaseH. pylori-infected patientsDaily triple therapyDays of omeprazoleDuodenal ulcer historyProtocol cure ratesProtocol eradication ratesTreat eradication ratesHelicobacter pylori eradicationPylori-infected patientsOAC patientsStudy medicationTreat populationUlcer historyPylori eradicationStudy drugAdverse eventsTwice DailyControlled TrialsDuodenal ulcerCure ratePatientsEffect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori.
Laine L, Estrada R, Trujillo M, Knigge K, Fennerty MB. Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori. Annals Of Internal Medicine 1998, 129: 547-50. PMID: 9758575, DOI: 10.7326/0003-4819-129-7-199810010-00007.Peer-Reviewed Original ResearchConceptsUrea breath testProton pump inhibitor therapyBreath test resultsProton pump inhibitorsBreath testInhibitor therapyH. pyloriDiagnostic testingCompletion of therapyProportion of patientsNegative breath test resultH. pylori infectionUrea breath test resultsLansoprazole therapyFalse-negative resultsGastroenterology clinicPylori infectionPatientsHelicobacter pyloriTherapyDuration of conversionPyloriPositive resultsLansoprazoleDaysUS double‐blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori
Laine, Johnson, Suchower, Ronca, Hwang, Neil. US double‐blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori. Alimentary Pharmacology & Therapeutics 1998, 12: 377-382. PMID: 9690729, DOI: 10.1046/j.1365-2036.1998.00303.x.Peer-Reviewed Original ResearchConceptsH. pylori eradicationDual therapyEradication ratePylori eradicationDuodenal ulcerControlled TrialsHelicobacter pylori eradication ratesOmeprazole/amoxycillinPylori eradication ratesCompletion of therapyActive duodenal ulcerH. pylori diagnosisEndoscopic biopsy testsAmoxycillin resistanceAmoxycillin therapyAdverse eventsAmoxycillinTherapyHelicobacter pyloriOmeprazolePatientsBiopsy testsProtocol analysisUlcersTrialsAccuracy of CLOtest after Helicobacter pylori therapy
Laine L, Suchower L, Johnson E, Ronca P, Neil G. Accuracy of CLOtest after Helicobacter pylori therapy. Gastrointestinal Endoscopy 1998, 47: 250-253. PMID: 9540877, DOI: 10.1016/s0016-5107(98)70321-9.Peer-Reviewed Original ResearchConceptsHelicobacter pylori therapyPylori therapyOmeprazole/amoxicillinCompletion of therapyDouble-blind trialRapid urease testingMore effective therapiesEndoscopic biopsy testsOmeprazole therapyAdditional therapyMost patientsDual therapyUnsuccessful treatmentUrease testingEffective therapyPositive testPatientsH. pyloriTherapyCLOtestBiopsy testsDecreased numberWeeksNegative resultsAmoxicillin
1995
The long-term management of patients with bleeding ulcers: Helicobacter pylori eradication instead of maintenance antisecretory therapy
Laine L. The long-term management of patients with bleeding ulcers: Helicobacter pylori eradication instead of maintenance antisecretory therapy. Gastrointestinal Endoscopy 1995, 41: 77-79. PMID: 7698632, DOI: 10.1016/s0016-5107(95)70283-0.Peer-Reviewed Original Research