COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.
Kowdley K, Hirschfield G, Coombs C, Malecha E, Bessonova L, Li J, Rathnayaka N, Mells G, Jones D, Trivedi P, Hansen B, Smith R, Wason J, Hiu S, Kareithi D, Mason A, Bowlus C, Muller K, Carbone M, Berenguer M, Milkiewicz P, Adekunle F, Villamil A. COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls. The American Journal Of Gastroenterology 2024 PMID: 39140490, DOI: 10.14309/ajg.0000000000003029.Peer-Reviewed Original ResearchPrimary biliary cholangitisObeticholic acidClinical outcomesFunctional unblindingPlacebo armBiliary cholangitisConfirmatory trialsUS healthcare claims databasePrimary biliary cholangitis patientsOCA therapyObeticholic acid treatmentPrimary composite endpointAs-treated analysisHealthcare claims databaseNegative clinical outcomesUncontrolled ascitesPlacebo patientsHepatic decompensationPrimary endpointLiver transplantationComposite endpointCommercial therapySafety signalsPlaceboTreatment crossoverHypercholesterolemia Is Associated With Dysregulation of Lipid Metabolism and Poor Prognosis in Primary Biliary Cholangitis
Zheng L, Tian S, Yang C, Li B, Jia G, Liu Y, Sun R, Wang X, Deng J, Zhang M, Cui L, Guo C, Zhou X, Leung P, Bowlus C, Gershwin M, Shang Y, Han Y. Hypercholesterolemia Is Associated With Dysregulation of Lipid Metabolism and Poor Prognosis in Primary Biliary Cholangitis. Clinical Gastroenterology And Hepatology 2024, 22: 1265-1274.e19. PMID: 38354969, DOI: 10.1016/j.cgh.2024.01.039.Peer-Reviewed Original ResearchPrimary biliary cholangitisPoor clinical outcomesAssociated with poor clinical outcomesHigh-risk patientsCirrhosis-related complicationsClinical outcomesTotal cholesterolBiliary cholangitisGLOBE scoreUntargeted lipidomicsLiver transplantationValidation cohortHealthy controlsRisk of poor clinical outcomesLipid metabolismBaseline total cholesterolComplete clinical dataLiver-related deathStratification of patientsAccurate stratification of patientsBaseline TC levelHigh-risk groupDysregulation of lipid metabolismAssociated with dysregulationUpregulated lipids