메뉴 건너뛰기




Volumn 63, Issue 23, 2014, Pages 2541-2548

Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: The GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab

Author keywords

evolocumab; ezetimibe; hypercholesterolemia; LDL cholesterol; statin intolerance

Indexed keywords

CHOLESTEROL; CREATINE KINASE; EVOLOCUMAB; EZETIMIBE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; KEXIN; LIVER ENZYME; LOW DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN RECEPTOR; MONOCLONAL ANTIBODY; PLACEBO; PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 9; SERINE PROTEINASE; SUBTILISIN; UNCLASSIFIED DRUG; VERY LOW DENSITY LIPOPROTEIN CHOLESTEROL; PCSK9 PROTEIN, HUMAN;

EID: 84902157271     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2014.03.019     Document Type: Article
Times cited : (491)

References (22)
  • 1
    • 26244432388 scopus 로고    scopus 로고
    • Efficacy and safety of cholesterol-lowering treatment: Prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins
    • C. Baigent, A. Keech, and P.M. Kearney et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins Lancet 366 2005 1267 1278
    • (2005) Lancet , vol.366 , pp. 1267-1278
    • Baigent, C.1    Keech, A.2    Kearney, P.M.3
  • 2
    • 78449281377 scopus 로고    scopus 로고
    • Efficacy and safety of more intensive lowering of LDL cholesterol: A meta-analysis of data from 170,000 participants in 26 randomised trials
    • Cholesterol Treatment Trialists' (CTT) Collaboration, C. Baigent, and L. Blackwell et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials Lancet 376 2010 1670 1681
    • (2010) Lancet , vol.376 , pp. 1670-1681
    • Baigent, C.1    Blackwell, L.2
  • 3
    • 84875727583 scopus 로고    scopus 로고
    • Discontinuation of statins in routine care settings: A cohort study
    • H. Zhang, J. Plutzky, and S. Skentzos et al. Discontinuation of statins in routine care settings: a cohort study Ann Intern Med 158 2013 526 534
    • (2013) Ann Intern Med , vol.158 , pp. 526-534
    • Zhang, H.1    Plutzky, J.2    Skentzos, S.3
  • 4
    • 82055192332 scopus 로고    scopus 로고
    • Statin discontinuation in high-risk patients: A systematic review of the evidence
    • Y.H. Gomez Sandoval, M.V. Braganza, and S.S. Daskalopoulou Statin discontinuation in high-risk patients: a systematic review of the evidence Curr Pharm Des 17 2011 3669 3689
    • (2011) Curr Pharm des , vol.17 , pp. 3669-3689
    • Gomez Sandoval, Y.H.1    Braganza, M.V.2    Daskalopoulou, S.S.3
  • 5
    • 84860615159 scopus 로고    scopus 로고
    • Mipomersen, an apolipoprotein B synthesis inhibitor, lowers low-density lipoprotein cholesterol in high-risk statin-intolerant patients: A randomized, double-blind, placebo-controlled trial
    • M.E. Visser, G. Wagener, and B.F. Baker et al. Mipomersen, an apolipoprotein B synthesis inhibitor, lowers low-density lipoprotein cholesterol in high-risk statin-intolerant patients: a randomized, double-blind, placebo-controlled trial Eur Heart J 33 2012 1142 1149
    • (2012) Eur Heart J , vol.33 , pp. 1142-1149
    • Visser, M.E.1    Wagener, G.2    Baker, B.F.3
  • 6
    • 84871945617 scopus 로고    scopus 로고
    • Efficacy and safety of a microsomal triglyceride transfer protein inhibitor in patients with homozygous familial hypercholesterolaemia: A single-arm, open-label, phase 3 study
    • M. Cuchel, E.A. Meagher, and H. du Toit Theron et al. Efficacy and safety of a microsomal triglyceride transfer protein inhibitor in patients with homozygous familial hypercholesterolaemia: a single-arm, open-label, phase 3 study Lancet 381 2013 40 46
    • (2013) Lancet , vol.381 , pp. 40-46
    • Cuchel, M.1    Meagher, E.A.2    Du Toit Theron, H.3
  • 7
    • 0037603589 scopus 로고    scopus 로고
    • Mutations in PCSK9 cause autosomal dominant hypercholesterolemia
    • M. Abifadel, M. Varret, and J.P. Rabès et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia Nat Genet 34 2003 154 156
    • (2003) Nat Genet , vol.34 , pp. 154-156
    • Abifadel, M.1    Varret, M.2    Rabès, J.P.3
  • 8
    • 33645103550 scopus 로고    scopus 로고
    • Sequence variations in PCSK9, low LDL, and protection against coronary heart disease
    • J.C. Cohen, E. Boerwinkle, T.H. Mosley Jr., and H.H. Hobbs Sequence variations in PCSK9, low LDL, and protection against coronary heart disease N Engl J Med 354 2006 1264 1272
    • (2006) N Engl J Med , vol.354 , pp. 1264-1272
    • Cohen, J.C.1    Boerwinkle, E.2    Mosley, Jr.T.H.3    Hobbs, H.H.4
  • 9
    • 33846679386 scopus 로고    scopus 로고
    • Molecular biology of PCSK9: Its role in LDL metabolism
    • J.D. Horton, J.C. Cohen, and H.H. Hobbs Molecular biology of PCSK9: its role in LDL metabolism Trends Biochem Sci 32 2007 71 77
    • (2007) Trends Biochem Sci , vol.32 , pp. 71-77
    • Horton, J.D.1    Cohen, J.C.2    Hobbs, H.H.3
  • 10
    • 84871326497 scopus 로고    scopus 로고
    • Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: The GAUSS randomized trial
    • D. Sullivan, A.G. Olsson, and R. Scott et al. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial JAMA 308 2012 2497 2506
    • (2012) JAMA , vol.308 , pp. 2497-2506
    • Sullivan, D.1    Olsson, A.G.2    Scott, R.3
  • 11
    • 84896389986 scopus 로고    scopus 로고
    • Design and rationale of the GAUSS-2 study trial: A double-blind, ezetimibe-controlled Phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy
    • L. Cho, M. Rocco, and D. Colquhoun et al. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled Phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy Clin Cardiol 37 2014 131 139
    • (2014) Clin Cardiol , vol.37 , pp. 131-139
    • Cho, L.1    Rocco, M.2    Colquhoun, D.3
  • 12
    • 0037126526 scopus 로고    scopus 로고
    • 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 report
    • 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 report Circulation 106 2002 3143 3421
    • (2002) Circulation , vol.106 , pp. 3143-3421
  • 13
    • 84902142901 scopus 로고    scopus 로고
    • Anti-PCSK9 monotherapy for hypercholesterolemia: The MENDEL-2 randomized, controlled phase III clinical trial of evolocumab
    • for the MENDEL-2 Investigators
    • M.J. Koren, P. Lundqvist, M. Bolognese for the MENDEL-2 Investigators Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab J Am Coll Cardiol 63 2014 2531 2540
    • (2014) J Am Coll Cardiol , vol.63 , pp. 2531-2540
    • Koren, M.J.1    Lundqvist, P.2    Bolognese, M.3
  • 14
    • 16644393741 scopus 로고    scopus 로고
    • Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). 1994
    • T.R. Pedersen, J. Kjekshus, and K. Berg et al. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994 Atheroscler Suppl 5 2004 81 87
    • (2004) Atheroscler Suppl , vol.5 , pp. 81-87
    • Pedersen, T.R.1    Kjekshus, J.2    Berg, K.3
  • 15
    • 84889018792 scopus 로고    scopus 로고
    • 2013 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 guidelines
    • Nov 7 [E-pub ahead of print].
    • N.J. Stone, J. Robinson, and A.H. Lichtenstein et al. 2013 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 guidelines J Am Coll Cardiol 2013 Nov 7 [E-pub ahead of print].
    • (2013) J Am Coll Cardiol
    • Stone, N.J.1    Robinson, J.2    Lichtenstein, A.H.3
  • 16
    • 0038054346 scopus 로고    scopus 로고
    • Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: A pooled analysis from two controlled phase III clinical studies
    • R.H. Knopp, C.A. Dujovne, and A. Le Beaut et al. Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: a pooled analysis from two controlled phase III clinical studies Int J Clin Pract 57 2003 363 368
    • (2003) Int J Clin Pract , vol.57 , pp. 363-368
    • Knopp, R.H.1    Dujovne, C.A.2    Le Beaut, A.3
  • 17
    • 77951622890 scopus 로고    scopus 로고
    • An update on the IMProved reduction of outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) design
    • R.M. Califf, Y. Lokhnygina, and C.P. Cannon et al. An update on the IMProved reduction of outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) design Am Heart J 159 2010 705 709
    • (2010) Am Heart J , vol.159 , pp. 705-709
    • Califf, R.M.1    Lokhnygina, Y.2    Cannon, C.P.3
  • 18
    • 84883232230 scopus 로고    scopus 로고
    • AMG145, a monoclonal antibody against proprotein convertase subtilisin kexin type 9, significantly reduces lipoprotein(a) in hypercholesterolemic patients receiving statin therapy: An analysis from the LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined with Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 Trial
    • N.R. Desai, P. Kohli, and R.P. Giugliano et al. AMG145, a monoclonal antibody against proprotein convertase subtilisin kexin type 9, significantly reduces lipoprotein(a) in hypercholesterolemic patients receiving statin therapy: an analysis from the LDL-C Assessment With Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined With Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 Trial Circulation 128 2013 962 969
    • (2013) Circulation , vol.128 , pp. 962-969
    • Desai, N.R.1    Kohli, P.2    Giugliano, R.P.3
  • 19
    • 84869220345 scopus 로고    scopus 로고
    • Low-density lipoprotein cholesterol-lowering effects of AMG 145, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease in patients with heterozygous familial hypercholesterolemia: The Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) randomized trial
    • F. Raal, R. Scott, and R. Somaratne et al. Low-density lipoprotein cholesterol-lowering effects of AMG 145, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease in patients with heterozygous familial hypercholesterolemia: the Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) randomized trial Circulation 126 2012 2408 2417
    • (2012) Circulation , vol.126 , pp. 2408-2417
    • Raal, F.1    Scott, R.2    Somaratne, R.3
  • 20
    • 84858638369 scopus 로고    scopus 로고
    • Effect of a monoclonal antibody to PCSK9 on LDL cholesterol
    • E.A. Stein, S. Mellis, and G.D. Yancopoulos et al. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol N Engl J Med 366 2012 1108 1118
    • (2012) N Engl J Med , vol.366 , pp. 1108-1118
    • Stein, E.A.1    Mellis, S.2    Yancopoulos, G.D.3
  • 21
    • 79953711138 scopus 로고    scopus 로고
    • Autoantibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase in patients with statin-associated autoimmune myopathy
    • A.L. Mammen, T. Chung, and L. Christopher-Stine et al. Autoantibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase in patients with statin-associated autoimmune myopathy Arthritis Rheum 63 2011 713 721
    • (2011) Arthritis Rheum , vol.63 , pp. 713-721
    • Mammen, A.L.1    Chung, T.2    Christopher-Stine, L.3
  • 22
    • 49949104757 scopus 로고    scopus 로고
    • SLCO1B1 variants and statin-induced myopathy-a genomewide study
    • Search Collaborative Group, E. Link, and S. Parish et al. SLCO1B1 variants and statin-induced myopathy-a genomewide study N Engl J Med 359 2008 789 799
    • (2008) N Engl J Med , vol.359 , pp. 789-799
    • Collaborative Group, S.1    Link, E.2    Parish, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.