2018
Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab
Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL, Investigators S. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. Journal Of Clinical Lipidology 2018, 12: 958-965. PMID: 29685591, DOI: 10.1016/j.jacl.2018.03.088.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Anti-IdiotypicAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCardiovascular DiseasesCholesterol, LDLFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHyperlipoproteinemia Type IIMaleMiddle AgedPlacebo EffectProportional Hazards ModelsProprotein Convertase 9Risk FactorsConceptsProprotein convertase subtilisin kexin type 9Major adverse cardiovascular eventsAdverse cardiovascular eventsPCSK9 inhibitionNon-FH patientsFH patientsCardiovascular eventsFamilial hypercholesterolemiaMean (SD) baseline LDL-C levelElevated low-density lipoprotein cholesterolFuture cardiovascular event ratesBaseline LDL-C levelsLow-density lipoprotein cholesterolSubtilisin kexin type 9Cardiovascular event reductionHard cardiovascular eventsHard cardiovascular outcomesPlacebo-controlled dataPrimary prevention patientsCardiovascular event ratesLDL-C reductionProportion of patientsClinical trial programLDL-C levelsIncidence rate ratios
2016
Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: Rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Lipid Lowering and SPIRE Cardiovascular Outcomes Trials
Ridker PM, Amarenco P, Brunell R, Glynn RJ, Jukema JW, Kastelein JJ, Koenig W, Nissen S, Revkin J, Santos RD, Schwartz PF, Yunis C, Tardif JC, Investigators S. Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: Rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Lipid Lowering and SPIRE Cardiovascular Outcomes Trials. American Heart Journal 2016, 178: 135-144. PMID: 27502861, DOI: 10.1016/j.ahj.2016.05.010.Peer-Reviewed Original ResearchConceptsCardiovascular outcome trialsOutcome trialsCardiovascular eventsPatient groupAtherogenic lipidsCholesterol levelsHigh-risk primary preventionSubtilisin kexin type 9Hepatic low-density lipoprotein receptorMonoclonal antibodiesAtherogenic cholesterol levelsIncident vascular eventsResidual cholesterol riskSafety of bococizumabVascular event ratesHigh-risk patientsPrior cardiovascular eventsClinical cardiovascular eventsEvident cardiovascular diseaseLDL cholesterol levelsHigh-risk populationHumanized monoclonal antibodyLow-density lipoprotein receptorHigh residual riskBroad patient groups
2007
Effect of Torcetrapib on Carotid Atherosclerosis in Familial Hypercholesterolemia
Kastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH, Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots ML. Effect of Torcetrapib on Carotid Atherosclerosis in Familial Hypercholesterolemia. New England Journal Of Medicine 2007, 356: 1620-1630. PMID: 17387131, DOI: 10.1056/nejmoa071359.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnticholesteremic AgentsAtherosclerosisAtorvastatinCarotid ArteriesCarotid Artery DiseasesCholesterol Ester Transfer ProteinsCholesterol, HDLCholesterol, LDLDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleHeptanoic AcidsHeterozygoteHumansHyperlipoproteinemia Type IIMaleMiddle AgedProspective StudiesPyrrolesQuinolinesConceptsCarotid intima-media thicknessIntima-media thicknessHDL cholesterol levelsCholesterol levelsFamilial hypercholesterolemiaMean low-density lipoprotein cholesterol levelLow-density lipoprotein cholesterol levelsMean carotid intima-media thicknessMaximum carotid intima-media thicknessAverage systolic blood pressureMean HDL cholesterol levelHigh-density lipoprotein cholesterolCarotid arterial wall thicknessCommon carotid segmentEffects of torcetrapibSecondary efficacy measuresLipoprotein cholesterol levelsSystolic blood pressureAtherosclerotic vascular diseaseCommon carotid arteryB-mode ultrasonographyProgression of diseaseArterial wall thicknessCholesteryl ester transfer proteinEster transfer proteinDesigns 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