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 duration
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
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