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
2017
Continued 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
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 modelPatients
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
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
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 inhibition
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 durationHow Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial
Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, Cannon CP. How Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial. The American Journal Of Gastroenterology 2009, 104: ajg2008149. PMID: 19174782, DOI: 10.1038/ajg.2008.149.Peer-Reviewed Original ResearchConceptsLiver-related hospitalizationsNon-steroidal anti-inflammatory drugsMonths of therapyAminotransferase elevationLiver eventsClinical trialsLong-term prospective clinical trialsLarge double-blind trialDeath/transplantHepatotoxicity of diclofenacTransplant/deathDouble-blind trialPrescribed non-steroidal anti-inflammatory drugsProspective clinical trialsAdverse hepatic effectsALT/ASTRates of laboratoryAnti-inflammatory drugsProspective trialArthritis patientsLiver injuryRheumatoid arthritisClinical eventsHepatic diseaseCausality assessment
2008
Tegaserod Treatment for Dysmotility-Like Functional Dyspepsia: Results of Two Randomized, Controlled Trials
Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M. Tegaserod Treatment for Dysmotility-Like Functional Dyspepsia: Results of Two Randomized, Controlled Trials. The American Journal Of Gastroenterology 2008, 103: ajg2008383. PMID: 18616658, DOI: 10.1111/j.1572-0241.2008.01953.x.Peer-Reviewed Original ResearchConceptsDysmotility-like functional dyspepsiaFunctional dyspepsiaSatisfactory symptom reliefTegaserod treatmentSymptom reliefDaily severity scoresPlacebo-controlled trialSevere baseline symptomsHelicobacter pylori statusTrial 2Trial 1Percentage of daysEarly satietyIdentical multicenterPostprandial fullnessStudy discontinuationAbdominal discomfortControlled TrialsMedication usePylori statusSeverity scoreReceptor agonistBaseline symptomsTegaserodClinical implications
2006
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
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-2
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
2004
Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial
Laine L, Maller ES, Yu C, Quan H, Simon T. Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial. Gastroenterology 2004, 127: 395-402. PMID: 15300570, DOI: 10.1053/j.gastro.2004.05.001.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalAspirinCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDouble-Blind MethodDrug Therapy, CombinationFemaleGastric MucosaHumansIbuprofenIncidenceIsoenzymesLactonesMaleMembrane ProteinsMiddle AgedOsteoarthritisProstaglandin-Endoperoxide SynthasesRisk FactorsStomach UlcerSulfonesTablets, Enteric-CoatedConceptsNonselective nonsteroidal anti-inflammatory drugsLow-dose aspirinCOX-2 selective inhibitorsDouble-blind trialUlcer incidenceNonselective NSAIDsLow-dose enteric-coated aspirinLow-dose aspirin usersCyclooxygenase-2 selective inhibitorSelective inhibitorNonsteroidal anti-inflammatory drugsEnteric-coated aspirinGastrointestinal mucosal injuryNumber of erosionsRisk of ulcerAnti-inflammatory drugsCOX-2 selective inhibitionYears of ageBaseline endoscopyAspirin usersDose aspirinErosive esophagitisCumulative incidenceMucosal injuryRepeat endoscopy
2003
Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study
Hawkey CJ, Laine L, Simon T, Quan H, Shingo S, Evans J. Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study. Gut 2003, 52: 820. PMID: 12740337, PMCID: PMC1773685, DOI: 10.1136/gut.52.6.820.Peer-Reviewed Original ResearchConceptsNon-selective non-steroidal antiinflammatory drugsGastroduodenal ulcersAdverse eventsRheumatoid arthritisLess gastrointestinal damageSecondary end pointsClinical adverse eventsDouble-blind studyRheumatoid arthritis patientsLog-rank testNon-steroidal antiinflammatory drugsGastroduodenal erosionsCumulative incidenceGastrointestinal damageArthritis patientsDuodenal ulcerLifetable analysisOverall incidenceSelective cyclooxygenaseAntiinflammatory drugsLower incidenceBlind studyMean changeTreatment groupsPlacebo
2002
Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis
Laine L, Bombardier C, Hawkey CJ, Davis B, Shapiro D, Brett C, Reicin A. Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology 2002, 123: 1006-1012. PMID: 12360461, DOI: 10.1053/gast.2002.36013.Peer-Reviewed Original ResearchConceptsUpper GI eventsClinical upper GI eventsSelective cyclooxygenase-2 inhibitorHigh-risk patientsGI eventsRisk factorsCyclooxygenase-2 inhibitorClinical characteristicsRheumatoid arthritisClinical eventsNonsteroidal anti-inflammatory drugsClinical GI eventsRisk of NSAIDUpper GI complicationsLow-risk patientsSevere rheumatoid arthritisPatients' clinical characteristicsRheumatoid arthritis patientsAbsolute risk reductionLow-risk subgroupsAnti-inflammatory drugsIndividual risk factorsRisk of eventsGI complicationsNonselective NSAIDsRandomized trial of normal saline solution injection versus bipolar electrocoagulation for treatment of patients with high-risk bleeding ulcers: Is local tamponade enough?
Laine L, Estrada R. Randomized trial of normal saline solution injection versus bipolar electrocoagulation for treatment of patients with high-risk bleeding ulcers: Is local tamponade enough? Gastrointestinal Endoscopy 2002, 55: 6-10. PMID: 11756906, DOI: 10.1067/mge.2002.120390.Peer-Reviewed Original ResearchConceptsSaline solution injectionSaline solution groupNormal saline solutionBipolar electrocoagulationLocal tamponadeNonbleeding visible vesselIndependent risk factorSolution injectionSolution groupTreatment of patientsSaline solutionMajor bleedingActive bleedingEndoscopic injectionHospital daysStandard therapyUlcer sizeLack of injuryClinical evidenceVisible vesselRisk factorsEffective treatmentPatientsBleedingUlcers
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 pyloriTherapyEsomeprazoleEndoscopic 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 therapyComparison 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
1999
A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2–specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis
Laine L, Harper S, Simon T, Bath R, Johanson J, Schwartz H, Stern S, Quan H, Bolognese J, Group F. A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2–specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Gastroenterology 1999, 117: 776-783. PMID: 10500058, DOI: 10.1016/s0016-5085(99)70334-3.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDouble-Blind MethodDuodenal UlcerFemaleGastric MucosaGastroscopyHumansIbuprofenIntestinal MucosaIsoenzymesLactonesMaleMembrane ProteinsMiddle AgedOsteoarthritisProstaglandin-Endoperoxide SynthasesStomach UlcerSulfonesConceptsUlcer ratesGastroduodenal ulcersCOX-2 specific inhibitionSymptoms of osteoarthritisNonspecific COX inhibitorNormal gastrointestinal tractTreatment of patientsBaseline endoscopyGastroduodenal ulcerationPlacebo groupCumulative incidenceOsteoarthritis patientsGastroduodenal mucosaWeek 12COX inhibitorsMucosal integrityCOX-2Gastrointestinal tractInflammatory sitesProstaglandin productionDoses 2AbstractTextEffective doseUlcersPatients
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 ratePatients