메뉴 건너뛰기




Volumn 9, Issue 6, 2015, Pages 758-769

Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial

(13)  Moriarty, Patrick M a   Thompson, Paul D b   Cannon, Christopher P c,d   Guyton, John R e   Bergeron, Jean f   Zieve, Franklin J g   Bruckert, Eric h   Jacobson, Terry A i   Kopecky, Stephen L j   Baccara Dinet, Marie T k   Du, Yunling l   Pordy, Robert l   Gipe, Daniel A l  


Author keywords

Clinical trials; Lipid lowering drugs; Lipoproteins; Monoclonal antibodies; PCSK9

Indexed keywords

ALANINE AMINOTRANSFERASE; ALIROCUMAB; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; ATORVASTATIN; CREATINE KINASE; EZETIMIBE; FLUINDOSTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPOPROTEIN A; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; PITAVASTATIN; PLACEBO; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL; AZETIDINE DERIVATIVE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

EID: 84947965019     PISSN: 19332874     EISSN: 18764789     Source Type: Journal    
DOI: 10.1016/j.jacl.2015.08.006     Document Type: Article
Times cited : (394)

References (30)
  • 1
    • 84903184698 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
    • N.J. Stone, J. Robinson, A.H. Lichtenstein, and 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 Circulation 63 2013 2899 2934
    • (2013) Circulation , vol.63 , pp. 2899-2934
    • Stone, N.J.1    Robinson, J.2    Lichtenstein, A.H.3
  • 2
    • 84908397421 scopus 로고    scopus 로고
    • National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 1 - Executive summary
    • T.A. Jacobson, M.K. Ito, K.C. Maki, and et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 - executive summary J Clin Lipidol 8 2014 473 488
    • (2014) J Clin Lipidol , vol.8 , pp. 473-488
    • Jacobson, T.A.1    Ito, M.K.2    Maki, K.C.3
  • 3
    • 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, L. Blackwell, J. Emberson, and 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    Emberson, J.3
  • 4
    • 81255165866 scopus 로고    scopus 로고
    • Diagnosis, prevention, and management of statin adverse effects and intolerance: Proceedings of a Canadian Working Group Consensus Conference
    • G.B. Mancini, S. Baker, J. Bergeron, and et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Proceedings of a Canadian Working Group Consensus Conference Can J Cardiol 27 2011 635 662
    • (2011) Can J Cardiol , vol.27 , pp. 635-662
    • Mancini, G.B.1    Baker, S.2    Bergeron, J.3
  • 5
    • 32444444724 scopus 로고    scopus 로고
    • Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients - The PRIMO study
    • E. Bruckert, G. Hayem, S. Dejager, C. Yau, and B. Begaud Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients - the PRIMO study Cardiovasc Drugs Ther 19 2005 403 414
    • (2005) Cardiovasc Drugs Ther , vol.19 , pp. 403-414
    • Bruckert, E.1    Hayem, G.2    Dejager, S.3    Yau, C.4    Begaud, B.5
  • 7
    • 84899883299 scopus 로고    scopus 로고
    • An assessment by the Statin Intolerance Panel: 2014 update
    • J.R. Guyton, H.E. Bays, S.M. Grundy, T.A. Jacobson The National Lipid Association Statin Intolerance P An assessment by the Statin Intolerance Panel: 2014 update J Clin Lipidol 8 2014 S72 S81
    • (2014) J Clin Lipidol , vol.8 , pp. S72-S81
    • Guyton, J.R.1    Bays, H.E.2    Grundy, S.M.3    Jacobson, T.A.4
  • 8
    • 84927742065 scopus 로고    scopus 로고
    • Statin-associated muscle symptoms: Impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management
    • E.S. Stroes, P.D. Thompson, A. Corsini, and et al. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management Eur Heart J 36 2015 1012 1022
    • (2015) Eur Heart J , vol.36 , pp. 1012-1022
    • Stroes, E.S.1    Thompson, P.D.2    Corsini, A.3
  • 9
    • 84903132374 scopus 로고    scopus 로고
    • A systematic review of statin-induced muscle problems in clinical trials
    • H.V. Ganga, H.B. Slim, and P.D. Thompson A systematic review of statin-induced muscle problems in clinical trials Am Heart J 168 2014 6 15
    • (2014) Am Heart J , vol.168 , pp. 6-15
    • Ganga, H.V.1    Slim, H.B.2    Thompson, P.D.3
  • 10
    • 84872093145 scopus 로고    scopus 로고
    • Effect of statins on skeletal muscle function
    • B.A. Parker, J.A. Capizzi, A.S. Grimaldi, and et al. Effect of statins on skeletal muscle function Circulation 127 2013 96 103
    • (2013) Circulation , vol.127 , pp. 96-103
    • Parker, B.A.1    Capizzi, J.A.2    Grimaldi, A.S.3
  • 11
    • 84862219022 scopus 로고    scopus 로고
    • Safety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy
    • J.M. McKenney, M.J. Koren, D.J. Kereiakes, C. Hanotin, A.C. Ferrand, and E.A. Stein Safety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy J Am Coll Cardiol 59 2012 2344 2353
    • (2012) J Am Coll Cardiol , vol.59 , pp. 2344-2353
    • McKenney, J.M.1    Koren, M.J.2    Kereiakes, D.J.3    Hanotin, C.4    Ferrand, A.C.5    Stein, E.A.6
  • 12
    • 84863494422 scopus 로고    scopus 로고
    • Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: A phase 2 randomised controlled trial
    • E.A. Stein, D. Gipe, J. Bergeron, and et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial Lancet 380 2012 29 36
    • (2012) Lancet , vol.380 , pp. 29-36
    • Stein, E.A.1    Gipe, D.2    Bergeron, J.3
  • 13
    • 84868689211 scopus 로고    scopus 로고
    • Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia
    • E.M. Roth, J.M. McKenney, C. Hanotin, G. Asset, and E.A. Stein Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia N Engl J Med 367 2012 1891 1900
    • (2012) N Engl J Med , vol.367 , pp. 1891-1900
    • Roth, E.M.1    McKenney, J.M.2    Hanotin, C.3    Asset, G.4    Stein, E.A.5
  • 14
    • 84906323762 scopus 로고    scopus 로고
    • Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: Results of a 24 week, double-blind, randomized phase 3 trial
    • E.M. Roth, M.R. Taskinen, H.N. Ginsberg, and et al. Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: results of a 24 week, double-blind, randomized phase 3 trial Int J Cardiol 176 2014 55 61
    • (2014) Int J Cardiol , vol.176 , pp. 55-61
    • Roth, E.M.1    Taskinen, M.R.2    Ginsberg, H.N.3
  • 15
    • 84926191670 scopus 로고    scopus 로고
    • Efficacy and safety of alirocumab in reducing lipids and cardiovascular events
    • J.G. Robinson, M. Farnier, M. Krempf, and et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events N Engl J Med 372 2015 1489 1499
    • (2015) N Engl J Med , vol.372 , pp. 1489-1499
    • Robinson, J.G.1    Farnier, M.2    Krempf, M.3
  • 16
    • 84908322310 scopus 로고    scopus 로고
    • Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY outcomes trial
    • G.G. Schwartz, L. Bessac, L.G. Berdan, and et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: rationale and design of the ODYSSEY outcomes trial Am Heart J 168 2014 682 689
    • (2014) Am Heart J , vol.168 , pp. 682-689
    • Schwartz, G.G.1    Bessac, L.2    Berdan, L.G.3
  • 17
    • 84929322473 scopus 로고    scopus 로고
    • Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: The ODYSSEY COMBO II randomized controlled trial
    • C.P. Cannon, B. Cariou, D. Blom, and et al. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial Eur Heart J 36 2015 1186 1194
    • (2015) Eur Heart J , vol.36 , pp. 1186-1194
    • Cannon, C.P.1    Cariou, B.2    Blom, D.3
  • 18
    • 84930179904 scopus 로고    scopus 로고
    • Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study
    • D.J. Kereiakes, J.G. Robinson, C.P. Cannon, and et al. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: the ODYSSEY COMBO I study Am Heart J 169 2015 906 915.e913
    • (2015) Am Heart J , vol.169 , pp. 906.e913-915.e913
    • Kereiakes, D.J.1    Robinson, J.G.2    Cannon, C.P.3
  • 19
    • 84939207026 scopus 로고    scopus 로고
    • Alirocumab as add-on to atorvastatin versus other lipid treatment strategies: ODYSSEY OPTIONS I randomized trial
    • H. Bays, D. Gaudet, R. Weiss, and et al. Alirocumab as add-on to atorvastatin versus other lipid treatment strategies: ODYSSEY OPTIONS I randomized trial J Clin Endocrinol Metab 100 2015 3140 3148
    • (2015) J Clin Endocrinol Metab , vol.100 , pp. 3140-3148
    • Bays, H.1    Gaudet, D.2    Weiss, R.3
  • 20
    • 79960539641 scopus 로고    scopus 로고
    • ESC/EAS Guidelines for the management of dyslipidaemias: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS)
    • Z. Reiner, A.L. Catapano, G. De Backer, and et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) Eur Heart J 32 2011 1769 1818
    • (2011) Eur Heart J , vol.32 , pp. 1769-1818
    • Reiner, Z.1    Catapano, A.L.2    De Backer, G.3
  • 21
    • 84923845326 scopus 로고    scopus 로고
    • Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: Design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial
    • P.M. Moriarty, T.A. Jacobson, E. Bruckert, and et al. Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial J Clin Lipidol 8 2014 554 561
    • (2014) J Clin Lipidol , vol.8 , pp. 554-561
    • Moriarty, P.M.1    Jacobson, T.A.2    Bruckert, E.3
  • 23
    • 60749108941 scopus 로고    scopus 로고
    • MMRM vs. LOCF: A comprehensive comparison based on simulation study and 25 NDA datasets
    • O. Siddiqui, H.M. Hung, and R. O'Neill MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets J Biopharm Stat 19 2009 227 246
    • (2009) J Biopharm Stat , vol.19 , pp. 227-246
    • Siddiqui, O.1    Hung, H.M.2    O'Neill, R.3
  • 24
  • 25
    • 57649211987 scopus 로고    scopus 로고
    • Long-term persistence with statin treatment in a not-for-profit health maintenance organization: A population-based retrospective cohort study in Israel
    • G. Chodick, V. Shalev, Y. Gerber, and et al. Long-term persistence with statin treatment in a not-for-profit health maintenance organization: a population-based retrospective cohort study in Israel Clin Ther 30 2008 2167 2179
    • (2008) Clin Ther , vol.30 , pp. 2167-2179
    • Chodick, G.1    Shalev, V.2    Gerber, Y.3
  • 26
    • 84883777708 scopus 로고    scopus 로고
    • Treatment strategies in patients with statin intolerance: The Cleveland Clinic experience
    • W.M. Mampuya, D. Frid, M. Rocco, and et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience Am Heart J 166 2013 597 603
    • (2013) Am Heart J , vol.166 , pp. 597-603
    • Mampuya, W.M.1    Frid, D.2    Rocco, M.3
  • 27
    • 84879549184 scopus 로고    scopus 로고
    • New therapeutic principles in dyslipidaemia: Focus on LDL and Lp(a) lowering drugs
    • G.D. Norata, C.M. Ballantyne, and A.L. Catapano New therapeutic principles in dyslipidaemia: focus on LDL and Lp(a) lowering drugs Eur Heart J 34 2013 1783 1789
    • (2013) Eur Heart J , vol.34 , pp. 1783-1789
    • Norata, G.D.1    Ballantyne, C.M.2    Catapano, A.L.3
  • 28
    • 84902157271 scopus 로고    scopus 로고
    • Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: The GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab
    • E. Stroes, D. Colquhoun, D. Sullivan, and et al. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab J Am Coll Cardiol 63 2014 2541 2548
    • (2014) J Am Coll Cardiol , vol.63 , pp. 2541-2548
    • Stroes, E.1    Colquhoun, D.2    Sullivan, D.3
  • 29
    • 64249120001 scopus 로고    scopus 로고
    • Ezetimibe monotherapy for cholesterol lowering in 2,722 people: Systematic review and meta-analysis of randomized controlled trials
    • A. Pandor, R.M. Ara, I. Tumur, and et al. Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials J Intern Med 265 2009 568 580
    • (2009) J Intern Med , vol.265 , pp. 568-580
    • Pandor, A.1    Ara, R.M.2    Tumur, I.3
  • 30
    • 0029043903 scopus 로고
    • Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor
    • J.W. Nawrocki, S.R. Weiss, M.H. Davidson, and et al. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor Arterioscler Thromb Vasc Biol 15 1995 678 682
    • (1995) Arterioscler Thromb Vasc Biol , vol.15 , pp. 678-682
    • Nawrocki, J.W.1    Weiss, S.R.2    Davidson, M.H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.