2016
Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency
Anker SD, Schroeder S, Atar D, Bax JJ, Ceconi C, Cowie MR, Crisp A, Dominjon F, Ford I, Ghofrani H, Gropper S, Hindricks G, Hlatky MA, Holcomb R, Honarpour N, Jukema JW, Kim AM, Kunz M, Lefkowitz M, Le Floch C, Landmesser U, McDonagh TA, McMurray JJ, Merkely B, Packer M, Prasad K, Revkin J, Rosano GM, Somaratne R, Stough WG, Voors AA, Ruschitzka F. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency. European Journal Of Heart Failure 2016, 18: 482-489. PMID: 27071916, DOI: 10.1002/ejhf.516.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingCause of DeathClinical Trials as TopicHeart FailureHospitalizationHumansMortalityOutcome Assessment, Health CareQuality of LifeTreatment OutcomeConceptsHeart failure clinical trialsComposite endpointClinical trialsNew composite endpointHeart failureHeart failure treatmentEffect of therapyHealth system perspectiveOverall treatment effectRepeat hospitalizationPlanned trialsFunctional statusFailure treatmentOutcome eventsPatient burdenEfficacy assessmentPatient experienceNew treatmentsTrialsAdverse effectsEfficiency of trialsEndpointTrial efficiencyTreatment effectsPrimary measure
2007
Designs of RADIANCE 1 and 2:carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis*
Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML. Designs of RADIANCE 1 and 2:carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis*. Current Medical Research And Opinion 2007, 23: 885-894. PMID: 17407645, DOI: 10.1185/030079907x182121.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlgorithmsAnticholesteremic AgentsAtherosclerosisAtorvastatinCarotid ArteriesClinical Trials as TopicDouble-Blind MethodDrug Therapy, CombinationFemaleHeptanoic AcidsHumansHyperlipidemia, Familial CombinedHyperlipoproteinemia Type IIMaleMiddle AgedModels, BiologicalPyrrolesQuinolinesResearch DesignTunica IntimaUltrasonographyConceptsCarotid intima-media thicknessMaximum carotid intima-media thicknessNCEP ATP III guidelinesATP III guidelinesCarotid ultrasound studiesDose of atorvastatinPrimary efficacy measureLDL-C levelsIntima-media thicknessHeterozygous familial hypercholesterolemiaEnd of studyB-mode ultrasonographyFurther outcome measuresRADIANCE studyEligible subjectsControlled TrialsAtherosclerotic progressionEfficacy measuresMixed hyperlipidemiaTreatment periodOutcome measuresUltrasound studyNumber of subjectsFamilial hypercholesterolemiaCarotid segments