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
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
Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison
Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, Reicin AS, Bombardier C, Weinblatt ME, van der Heijde D, Erdmann E, Laine L, Committee F. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. The Lancet 2006, 368: 1771-1781. PMID: 17113426, DOI: 10.1016/s0140-6736(06)69666-9.Peer-Reviewed Original ResearchConceptsThrombotic cardiovascular eventsNon-steroidal anti-inflammatory drugsCardiovascular eventsHazard ratioRheumatoid arthritisCyclo-oxygenase-2 (COX-2) selective inhibitorsTraditional non-steroidal anti-inflammatory drugsCOX-2 selective inhibitorsPrespecified pooled analysisRelative cardiovascular riskTraditional NSAID diclofenacUpper gastrointestinal eventsPlacebo-controlled trialAverage treatment durationAnti-inflammatory drugsSelective inhibitorLong-term useDiclofenac groupEtoricoxib groupGastrointestinal eventsMultinational EtoricoxibCardiovascular outcomesCardiovascular riskTreat analysisClinical eventsReview article: gastrointestinal bleeding with low‐dose aspirin – what's the risk?
LAINE L. Review article: gastrointestinal bleeding with low‐dose aspirin – what's the risk? Alimentary Pharmacology & Therapeutics 2006, 24: 897-908. PMID: 16948802, DOI: 10.1111/j.1365-2036.2006.03077.x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsLow-dose aspirinGastrointestinal bleedingPlacebo-controlled trialRelative riskNon-aspirin non-steroidal anti-inflammatory drugsLarge Danish cohort studyRandomized placebo-controlled trialNon-steroidal anti-inflammatory drugsAbsolute annual incidenceDanish cohort studyMajor gastrointestinal bleedingUpper gastrointestinal bleedingEnteric-coated aspirinAbsolute rate increaseAnti-inflammatory drugsEndoscopic trialsCorticosteroid useAnticoagulant therapyCardiovascular benefitsCohort studyAnnual incidenceVascular protectionClinical eventsUlcer incidenceOdds ratio
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 doseRofecoxibWeeksPlaceboPatientsOsteoarthritisIncidenceDoseIbuprofenUlcerationMucosaEndoscopyHow to explain outcome differences in dyspepsia studies
Fennerty M, Laine L. How to explain outcome differences in dyspepsia studies. 2000, 421-425. DOI: 10.1007/978-94-011-3927-4_44.ChaptersNon-ulcer dyspepsiaPylori infectionAdequate observation periodPlacebo-controlled trialPeptic ulcer diseaseCause of symptomsH. pylori infectionHelicobacter pylori infectionClinical treatment trialsMajor aetiological factorUlcer diseaseTreatment trialsUpper abdomenAetiological factorsEarly trial resultsStudy populationOutcome differencesEpidemiological studiesH. pyloriDyspepsiaDiscordant resultsTrial resultsObservation periodSerious methodological deficienciesTrials