128
Views
3
CrossRef citations to date
0
Altmetric
Review

Clinical efficacy and safety of evolocumab for low-density lipoprotein cholesterol reduction

, &
Pages 163-169 | Published online: 19 Apr 2016

References

  • BraunsteinJBChengACohnGAggarwalMNassCMBlumenthalRSLipid disorders: justification of methods and goals of treatmentChest2001120397998811555537
  • SendersASandoKWahbehHHillerAPShintoLManaging psychological stress in the multiple sclerosis medical visit: Patient perspectives and unmet needsJ Health Psychol Epub20141219
  • National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final reportCirculation2002106253143342112485966
  • InvestigatorsA-HBodenWEProbstfieldJLNiacin in patients with low HDL cholesterol levels receiving intensive statin therapyN Engl J Med2011365242255226722085343
  • GroupASGinsbergHNElamMBEffects of combination lipid therapy in type 2 diabetes mellitusN Engl J Med2010362171563157420228404
  • TaylorFHuffmanMDMacedoAFStatins for the primary prevention of cardiovascular diseaseCochrane Database Syst Rev20131CD00481623440795
  • Cholesterol Treatment Trialists’ (CTT) CollaboratorsMihaylovaBEmbersonJThe effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trialsLancet2012380984158159022607822
  • JoyTRHegeleRANarrative review: statin-related myopathyAnn Int Med20091501285886819528564
  • FellstromBCJardineAGSchmiederRERosuvastatin and cardiovascular events in patients undergoing hemodialysisN Engl J Med2009360141395140719332456
  • KjekshusJApetreiEBarriosVRosuvastatin in older patients with systolic heart failureN Engl J Med2007357222248226117984166
  • GissiHFITavazziLMaggioniAPEffect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trialLancet200837296451231123918757089
  • WannerCKraneVMarzWAtorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysisN Engl J Med2005353323824816034009
  • CannonCPBlazingMAGiuglianoRPEzetimibe added to statin therapy after acute coronary syndromesN Engl J Med2015372252387239726039521
  • BohulaEAGiuglianoRPCannonCPAchievement of dual low-density lipoprotein cholesterol and high-sensitivity C-reactive protein targets more frequent with the addition of ezetimibe to simvastatin and associated with better outcomes in IMPROVE-ITCirculation2015132131224123326330412
  • CohenJCBoerwinkleEMosleyTHJrHobbsHHSequence variations in PCSK9, low LDL, and protection against coronary heart diseaseN Engl J Med2006354121264127216554528
  • HortonJDCohenJCHobbsHHMolecular biology of PCSK9: its role in LDL metabolismTrends Biochem Sci2007322717717215125
  • SteinEAMellisSYancopoulosGDEffect of a monoclonal antibody to PCSK9 on LDL cholesterolN Engl J Med2012366121108111822435370
  • AbifadelMVarretMRabesJPMutations in PCSK9 cause autosomal dominant hypercholesterolemiaNat Genet200334215415612730697
  • CiceroAFCollettiABorghiCProfile of evolocumab and its potential in the treatment of hyperlipidemiaDrug Des Devel Ther2015930733082
  • SteinEWassermanSDiasCScottRRaalFAMG145Drug Future201338451459
  • Repatha™ [package insert]Thousand Oaks, CAAmgen Inc.2015
  • GazzerroPProtoMCGangemiGPharmacological actions of statins: a critical appraisal in the management of cancerPharmacol Rev201264110214622106090
  • KorenMJLundqvistPBologneseMAnti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumabJ Am Coll Cardiol201463232531254024691094
  • RobinsonJGNedergaardBSRogersWJEffect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trialJAMA2014311181870188224825642
  • BlomDJHalaTBologneseMA 52-week placebo-controlled trial of evolocumab in hyperlipidemiaN Engl J Med2014370191809181924678979
  • SabatineMSGiuglianoRPWiviottSDEfficacy and safety of evolocumab in reducing lipids and cardiovascular eventsN Engl J Med2015372161500150925773607
  • StroesEColquhounDSullivanDAnti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumabJ Am Coll Cardiol201463232541254824694531
  • RaalFJSteinEADufourRPCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trialLancet2014385996533134025282519
  • RaalFJHonarpourNBlomDJInhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trialLancet2015385996534135025282520
  • AmgenFurther cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER)2015 Available from: https://clinicaltrials.gov/ct2/show/NCT01764633?term=FOURIER&rank=6Accessed August 25, 2015
  • AmgenStudy to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen2013 Available from: https://clinicaltrials.gov/ct2/show/NCT01879319?term=20120356&rank=1Accessed August 25, 2015
  • AmgenStudy to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen2013 Available from: https://clinicaltrials.gov/show/NCT01849497Accessed August 25, 2015
  • WalldiusGJungnerIThe apoB/apoA-I ratio: a strong, new risk factor for cardiovascular disease and a target for lipid-lowering therapy–a review of the evidenceJ Int Med20062595493519
  • BaertFNomanMVermeireSInfluence of immunogenicity on the long-term efficacy of infliximab in Crohn’s diseaseN Engl J Med2003348760160812584368
  • HardingFASticklerMMRazoJDuBridgeRBThe immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regionsMAbs20102325626520400861
  • StoneNJRobinsonJGLichtensteinAH2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice GuidelinesJ Am Coll Cardiol20146325 Pt B2889293424239923
  • CromwellWCOtvosJDKeyesMJLDL particle number and risk of future cardiovascular disease in the Framingham offspring study – implications for LDL managementJ Clin Lipidol20071658359219657464
  • Emerging Risk Factors CollaborationErqouSKaptogeSLipoprotein(a) concentration and the risk of coronary heart disease, stroke, and nonvascular mortalityJAMA2009302441242319622820
  • BoekholdtSMArsenaultBJMoraSAssociation of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysisJAMA2012307121302130922453571
  • (ICER) TIfCaERPCSK9 inhibitor therapies for high cholesterol: effectiveness, value, and value-based price benchmarks2015 Available from: http://cepac.icer-review.org/wp-content/uploads/2015/04/PCSK9_Draft_Report_0908151.pdfAccessed October 9, 2015
  • RobsonJLipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular diseaseHeart200894101331133218701534
  • NavareseEPKolodziejczakMSchulzeVEffects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: a systematic review and meta-analysisAnn Int Med20151631405125915661
  • LennernasHClinical pharmacokinetics of atorvastatinClin Pharmacokinet200342131141116014531725