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Volumn 75, Issue 14, 2015, Pages 1699-1705

Alirocumab: First Global Approval

Author keywords

[No Author keywords available]

Indexed keywords

ALIROCUMAB; ATORVASTATIN; EZETIMIBE; KEXIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; SUBTILISIN; MONOCLONAL ANTIBODY;

EID: 84942500745     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-015-0469-8     Document Type: Article
Times cited : (13)

References (24)
  • 2
    • 84942499844 scopus 로고    scopus 로고
    • European Medicines Agency Accessed 1 Sept 2015
    • European Medicines Agency. Praluent (alirocumab) - summary of opinion. 2015. http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion-Initial-authorisation/human/003882/WC500190416.pdf. Accessed 1 Sept 2015.
    • (2015) Praluent (Alirocumab) - Summary of Opinion
  • 6
    • 84975525453 scopus 로고    scopus 로고
    • Dynamics between the monoclonal antibody sar236553/regn727, proprotein convertase subtilisin/kexin type 9 (Pcsk9) and low-density lipoprotein cholesterol (LDL-C) Levels (Funding: Regeneron/Sanofi) [abstract no. 298]
    • McKenney J, Swergold G, DiCioccio T, et al. Dynamics between the monoclonal antibody sar236553/regn727, proprotein convertase subtilisin/kexin type 9 (Pcsk9) and low-density lipoprotein cholesterol (LDL-C) Levels (Funding: Regeneron/Sanofi) [abstract no. 298]. In: European Atherosclerosis Society Annual Congress. 2013.
    • (2013) European Atherosclerosis Society Annual Congress
    • McKenney, J.1    Swergold, G.2    DiCioccio, T.3
  • 7
    • 84911411495 scopus 로고    scopus 로고
    • A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects
    • 4262094 1:CAS:528:DC%2BC2cXitVamsLbJ 25256660
    • Lunven C, Paehler T, Poitiers F, et al. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects. Cardiovasc Ther. 2014;32(6):297-301.
    • (2014) Cardiovasc Ther. , vol.32 , Issue.6 , pp. 297-301
    • Lunven, C.1    Paehler, T.2    Poitiers, F.3
  • 9
    • 84904383122 scopus 로고    scopus 로고
    • Randomized, partial blind study of the pharmacodynamics, pharmacokinetics and safety of multiple subcutaneous doses of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, administered every 4 weeks alone or in combination with ezetimibe or fenofibrate in healthy subjects [abstract no. 1183-131]
    • Rey J, Poitiers F, Paehler T, et al. Randomized, partial blind study of the pharmacodynamics, pharmacokinetics and safety of multiple subcutaneous doses of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, administered every 4 weeks alone or in combination with ezetimibe or fenofibrate in healthy subjects [abstract no. 1183-131]. J Am Coll Cardiol. 2014;63(12 Supplement):A1375.
    • (2014) J Am Coll Cardiol. , vol.63 , Issue.12 , pp. A1375
    • Rey, J.1    Poitiers, F.2    Paehler, T.3
  • 10
    • 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
    • Kereiakes DJ, Robinson JG, Cannon CP, 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. 2015;169(6):906-15.e13.
    • (2015) Am Heart J. , vol.169 , Issue.6 , pp. 906-906e13
    • Kereiakes, D.J.1    Robinson, J.G.2    Cannon, C.P.3
  • 11
    • 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
    • 4430683 25687353
    • Cannon CP, Cariou B, Blom D, 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. 2015;36:1186-94.
    • (2015) Eur Heart J. , vol.36 , pp. 1186-1194
    • Cannon, C.P.1    Cariou, B.2    Blom, D.3
  • 12
    • 84926191670 scopus 로고    scopus 로고
    • Efficacy and safety of alirocumab in reducing lipids and cardiovascular events
    • 1:CAS:528:DC%2BC2MXotFGlsbc%3D 25773378
    • Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1489-99.
    • (2015) N Engl J Med. , vol.372 , Issue.16 , pp. 1489-1499
    • Robinson, J.G.1    Farnier, M.2    Krempf, M.3
  • 13
    • 84939207026 scopus 로고    scopus 로고
    • Alirocumab as add-on to atorvastatin versus other lipid treatment strategies: ODYSSEY OPTIONS i randomized trial
    • 4524987 1:CAS:528:DC%2BC2MXhsVCmtLrP 26030325
    • Bays H, Gaudet D, Weiss R, et al. Alirocumab as add-on to atorvastatin versus other lipid treatment strategies: ODYSSEY OPTIONS I randomized trial. J Clin Endocrinol Metab. 2015;100(8):3140-8.
    • (2015) J Clin Endocrinol Metab. , vol.100 , Issue.8 , pp. 3140-3148
    • Bays, H.1    Gaudet, D.2    Weiss, R.3
  • 14
    • 84937643240 scopus 로고    scopus 로고
    • Efficacy and safety of combining alirocumab with atorvastatin or rosuvastatin versus statin intensification or adding ezetimibe in high cardiovascular risk patients: ODYSSEY OPTIONS i and II [abstract]
    • Bays H, Farnier M, Gaudet D, et al. Efficacy and safety of combining alirocumab with atorvastatin or rosuvastatin versus statin intensification or adding ezetimibe in high cardiovascular risk patients: ODYSSEY OPTIONS I and II [abstract]. Circulation. 2015;130(23):2118-9.
    • (2015) Circulation. , vol.130 , Issue.23 , pp. 2118-2119
    • Bays, H.1    Farnier, M.2    Gaudet, D.3
  • 15
    • 84942500460 scopus 로고    scopus 로고
    • Phase 3 randomized trial evaluating alirocumab every four weeks dosing as add-on to statin or as monotherapy: ODYSSEY CHOICE i [abstract no. 0254]
    • Roth E, Rader DJ, Moriarty P. Phase 3 randomized trial evaluating alirocumab every four weeks dosing as add-on to statin or as monotherapy: ODYSSEY CHOICE I [abstract no. 0254]. In: 17th International Symposium on Atherosclerosis. 2015.
    • (2015) 17th International Symposium on Atherosclerosis
    • Roth, E.1    Rader, D.J.2    Moriarty, P.3
  • 16
    • 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
    • 1:CAS:528:DC%2BC38XovV2ntLs%3D 22463922
    • McKenney JM, Koren MJ, Kereiakes DJ, et al. 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. 2012;59(25):2344-53.
    • (2012) J Am Coll Cardiol. , vol.59 , Issue.25 , pp. 2344-2353
    • McKenney, J.M.1    Koren, M.J.2    Kereiakes, D.J.3
  • 17
    • 84868689211 scopus 로고    scopus 로고
    • Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia
    • 1:CAS:528:DC%2BC38XhslKktrzM 23113833
    • Roth EM, McKenney JM, Hanotin C, et al. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med. 2012;367(20):1891-900.
    • (2012) N Engl J Med. , vol.367 , Issue.20 , pp. 1891-1900
    • Roth, E.M.1    McKenney, J.M.2    Hanotin, C.3
  • 18
    • 84975499314 scopus 로고    scopus 로고
    • Efficacy and safety of alirocumab in Japanese patients with hypercholesterolemia on stable statin therapy: First data with the 75 mg every two weeks dose [abstract no. 13651]
    • Teramoto T, Kobayashi M, Uno K, et al. Efficacy and safety of alirocumab in Japanese patients with hypercholesterolemia on stable statin therapy: first data with the 75 mg every two weeks dose [abstract no. 13651]. In: 87th Annual Scientific Sessions of the American Heart Association. 2014.
    • (2014) 87th Annual Scientific Sessions of the American Heart Association
    • Teramoto, T.1    Kobayashi, M.2    Uno, K.3
  • 19
    • 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
    • 25037695
    • Roth EM, Taskinen MR, Ginsberg HN, 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. 2014;176(1):55-61.
    • (2014) Int J Cardiol. , vol.176 , Issue.1 , pp. 55-61
    • Roth, E.M.1    Taskinen, M.R.2    Ginsberg, H.N.3
  • 20
    • 84922938167 scopus 로고    scopus 로고
    • ODYSSEY ALTERNATIVE: Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody, alirocumab, versus ezetimibe, in patients with statin intolerance as defined by a placebo run-in and statin rechallenge arm
    • Moriarty PM, Thompson PD, Cannon CP, et al. ODYSSEY ALTERNATIVE: efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody, alirocumab, versus ezetimibe, in patients with statin intolerance as defined by a placebo run-in and statin rechallenge arm. Circulation. 2014;130(23):2108-9.
    • (2014) Circulation. , vol.130 , Issue.23 , pp. 2108-2109
    • Moriarty, P.M.1    Thompson, P.D.2    Cannon, C.P.3
  • 21
    • 84975480338 scopus 로고    scopus 로고
    • Alirocumab in patients with hypercholesterolemia not on statin therapy: The ODYSSEY CHOICE II study [abstract no. 0269]
    • Stroes E, Guyton J, Farnier M. Alirocumab in patients with hypercholesterolemia not on statin therapy: the ODYSSEY CHOICE II study [abstract no. 0269]. In: 17th International Symposium on Atherosclerosis. 2015.
    • (2015) 17th International Symposium on Atherosclerosis
    • Stroes, E.1    Guyton, J.2    Farnier, M.3
  • 22
    • 84975526714 scopus 로고    scopus 로고
    • Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolaemia not adequately controlled with current lipid-lowering therapy: Results of ODYSSEY FH i and FH II studies [abstract no. 2125]
    • Kastelein JJ, Robinson JG, Farnier M. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolaemia not adequately controlled with current lipid-lowering therapy: results of ODYSSEY FH I and FH II studies [abstract no. 2125]. In: European Society of Cardiology. 2015.
    • (2015) European Society of Cardiology
    • Kastelein, J.J.1    Robinson, J.G.2    Farnier, M.3
  • 23
    • 84937637206 scopus 로고    scopus 로고
    • ODYSSEY HIGH FH: Efficacy and safety of alirocumab in patients with severe heterozygous familial hypercholesterolemia
    • Ginsberg HN, Rader DJ, Raal FJ. ODYSSEY HIGH FH: efficacy and safety of alirocumab in patients with severe heterozygous familial hypercholesterolemia. Circulation. 2014;130(23):2119.
    • (2014) Circulation. , vol.130 , Issue.23 , pp. 2119
    • Ginsberg, H.N.1    Rader, D.J.2    Raal, F.J.3
  • 24
    • 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
    • 1:CAS:528:DC%2BC38XnslShu7s%3D 22633824
    • Stein EA, Gipe D, Bergeron J, 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. 2012;380(9836):29-36.
    • (2012) Lancet. , vol.380 , Issue.9836 , pp. 29-36
    • Stein, E.A.1    Gipe, D.2    Bergeron, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.