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
2003
Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo
Hawkey C, 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. European Journal Of Gastroenterology & Hepatology 2003, 15: 835. DOI: 10.1097/00042737-200307000-00021.Peer-Reviewed Original ResearchIncidence 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
1995
A randomized, double-blind comparison of placebo, etodolac, and naproxen on gastrointestinal injury and prostaglandin production
Laine L, Sloane R, Ferretti M, Cominelli F. A randomized, double-blind comparison of placebo, etodolac, and naproxen on gastrointestinal injury and prostaglandin production. Gastrointestinal Endoscopy 1995, 42: 428-433. PMID: 8566633, DOI: 10.1016/s0016-5107(95)70045-5.Peer-Reviewed Original ResearchConceptsProstaglandin productionWeek 1Gastrointestinal injuryGastric injuryHealthy volunteersDimension of ulcersMucosal prostaglandin productionDouble-blind trialDouble-blind comparisonWeeks of treatmentMean numberProstaglandin E2 productionAnti-ulcer drugsGastroduodenal injuryGastrointestinal symptomsUlcer complicationsPrior endoscopyStandard NSAIDsGastric erosionsGastric ulcerMucosal defectsUlcer scoreWeek 4E2 productionPlacebo