2017
Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. New England Journal Of Medicine 2017, 376: 1517-1526. PMID: 28304227, DOI: 10.1056/nejmoa1614062.Peer-Reviewed Original ResearchConceptsLDL cholesterol levelsProprotein convertase subtilisin kexin type 9Antidrug antibodiesCholesterol levelsLipoprotein cholesterolLow-density lipoprotein cholesterolSubtilisin kexin type 9Antidrug antibody formationLipid-lowering trialsCommon adverse eventsMajor cardiovascular eventsDensity lipoprotein cholesterolInjection site reactionsTime of enrollmentHumanized monoclonal antibodyCardiovascular eventsStatin therapyAdverse eventsTotal cholesterolMultinational trialTreatment periodBococizumabApolipoprotein BPatientsType 9
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 ResearchConceptsHeart 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
Biomarkers in the Prevention and Treatment of Atherosclerosis: Need, Validation, and Future
Revkin JH, Shear CL, Pouleur HG, Ryder SW, Orloff DG. Biomarkers in the Prevention and Treatment of Atherosclerosis: Need, Validation, and Future. Pharmacological Reviews 2007, 59: 40-53. PMID: 17329547, DOI: 10.1124/pr.59.1.1.Peer-Reviewed Original ResearchConceptsAtherosclerotic progressionClinical trialsCardiovascular diseaseCardiovascular outcomesSurrogate markerCarotid intima-media thicknessIdeal surrogate markerFuture cardiovascular eventsIntima-media thicknessCause of morbidityNew cardiovascular drugsQuantitative coronary angiographyTreatment of atherosclerosisNovel therapeutic strategiesB-mode ultrasoundAtheroma volumeCardiovascular eventsCardiovascular riskCoronary angiographyEffective therapySurrogate endpointsCardiovascular drugsTherapeutic strategiesIntravascular ultrasoundSuch trials