Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the open-label study of long-term evaluation against LDL-C (OSLER) randomized trial

Circulation

Volumn 129, Issue 2, 2014, Pages 234-243

  Koren, Michael J ^a   Giugliano, Robert P ^b   Raal, Frederick J ^c   Sullivan, David ^d   Bolognese, Michael ^e   Langslet, Gisle ^f   Civeira, Fernando ^g   Somaratne, Ransi ^h   Nelson, Patric ^h   Liu, Thomas ^h   Scott, Rob ^h   Wasserman, Scott M ^h   Sabatine, Marc S ^b  

^a Memorial Laboratories   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^d ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^e Bethesda Health Research Center   (United States)

^f OSLO UNIVERSITY HOSPITAL   (Norway)

^g HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^h AMGEN INC   (United States)

Author keywords

cholesterol; hypercholesterolemia; LDL; randomized controlled trial; serine proteases

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTILIPEMIC AGENT; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; ATORVASTATIN; CREATINE KINASE; EVOLOCUMAB; EZETIMIBE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LIPOPROTEIN A; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL;

ABNORMAL SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ARTHRALGIA; ARTICLE; BACKACHE; CONTROLLED STUDY; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEADACHE; HEALTH CARE QUALITY; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRANSAMINASEMIA; INFLUENZA; INJECTION SITE REACTION; INSOMNIA; LONG TERM CARE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION;

CHOLESTEROL, LDL; HYPERCHOLESTEROLEMIA; RANDOMIZED CONTROLLED TRIAL; SERINE PROTEASES;

AGED; ANTIBODIES, MONOCLONAL; CHOLESTEROL, LDL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; HYPERCHOLESTEROLEMIA; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; PROPROTEIN CONVERTASES; SERINE ENDOPEPTIDASES; STANDARD OF CARE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84892679366     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.113.007012     Document Type: Article

References (26)

1. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670-1681.
2. Stein EA, Swergold GD. Potential of proprotein convertase subtilisin/kexin type 9 based therapeutics. Curr Atheroscler Rep. 2013;15:310.
3. Dias CS, Shaywitz AJ, Wasserman SM, Smith BP, Gao B, Stolman DS, Crispino CP, Smirnakis KV, Emery MG, Colbert A, Gibbs JP, Retter MW, Cooke BP, Uy ST, Matson M, Stein EA. Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins. J Am Coll Cardiol. 2012;60:1888-1898.
4. Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F, Liu T, Mohanavelu S, Hoffman EB, McDonald ST, Abrahamsen TE, Wasserman SM, Scott R, Sabatine MS. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012;380:2007-2017.
5. Koren MJ, Scott R, Kim JB, Knusel B, Liu T, Lei L, Bolognese M, Wasserman SM. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, doubleblind, placebo-controlled, phase 2 study. Lancet. 2012;380:1995-2006.
6. McKenney JM, Koren MJ, Kereiakes DJ, Hanotin C, Ferrand AC, Stein EA. 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;59:2344-2353.
7. Raal F, Scott R, Somaratne R, Bridges I, Li G, Wasserman SM, Stein EA. 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. 2012;126:2408-2417.
8. Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med. 2012;367:1891-1900.
9. Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, Lisbon E, Gutierrez M, Webb C, Wu R, Du Y, Kranz T, Gasparino E, Swergold GD. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012;366:1108-1118.
10. Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012;308:2497-2506.
11. Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the PCSK9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013;128:2113-2120.
12. Kohli P, Desai NR, Giugliano RP, Kim JB, Somaratne R, Huang F, Knusel B, McDonald S, Abrahamsen T, Wasserman SM, Scott R, Sabatine MS. Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2012;35:385-391.
13. Martin SS, Blaha MJ, Elshazly MB, Brinton EA, Toth PP, McEvoy JW, Joshi PH, Kulkarni KR, Mize PD, Kwiterovich PO, Defilippis AP, Blumenthal RS, Jones SR. Friedewald-estimated versus directly measured low-density lipoprotein cholesterol and treatment implications. J Am Coll Cardiol. 2013;62:732-739.
14. Lipid Research Clinics. Manual of Laboratory Operations: Lipid and Lipoprotein Analysis (Revised). Washington, DC: Department of Health and Human Services; 1982. Publication No. NIH 75-67815.
15. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499-502.
16. Clarke R, Peden JF, Hopewell JC, Kyriakou T, Goel A, Heath SC, Parish S, Barlera S, Franzosi MG, Rust S, Bennett D, Silveira A, Malarstig A, Green FR, Lathrop M, Gigante B, Leander K, de Faire U, Seedorf U, Hamsten A, Collins R, Watkins H, Farrall M; PROCARDIS Consortium. Genetic variants associated with Lp(a) lipoprotein level and coronary disease. N Engl J Med. 2009;361:2518-2528.
17. Ference BA, Yoo W, Alesh I, Mahajan N, Mirowska KK, Mewada A, Kahn J, Afonso L, Williams KA Sr, Flack JM. Effect of long-term exposure to lower low-density lipoprotein cholesterol beginning early in life on the risk of coronary heart disease: a mendelian randomization analysis. J Am Coll Cardiol. 2012;60:2631-2639.
18. Hsia J, MacFadyen JG, Monyak J, Ridker PM. Cardiovascular event reduction and adverse events among subjects attaining low-density lipoprotein cholesterol
19. Wiviott SD, Cannon CP, Morrow DA, Ray KK, Pfeffer MA, Braunwald E; PROVE IT-TIMI 22 Investigators. Can low-density lipoprotein be too low? The safety and efficacy of achieving very low low-density lipoprotein with intensive statin therapy: a PROVE IT-TIMI 22 substudy. J Am Coll Cardiol. 2005;46:1411-1416.
20. Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JJ, Komajda M, Lopez-Sendon J, Mosca L, Tardif JC, Waters DD, Shear CL, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B; ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007;357:2109-2122.
21. AIM-HIGH Investigators, Boden WE, Probstfield JL, Anderson T, Chaitman BR, Desvignes-Nickens P, Koprowicz K, McBride R, Teo K, Weintraub W. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med. 2011;365:2255-2267.
22. Goldman S, McCarren M, Morkin E, Ladenson PW, Edson R, Warren S, Ohm J, Thai H, Churby L, Barnhill J, O'Brien T, Anand I, Warner A, Hattler B, Dunlap M, Erikson J, Shih MC, Lavori P. DITPA (3,5-diiodothyropropionic acid), a thyroid hormone analog to treat heart failure: phase II trial Veterans Affairs Cooperative Study. Circulation. 2009;119:3093-3100.
23. Wright RS. Recent clinical trials evaluating benefit of drug therapy for modification of HDL cholesterol. Curr Opin Cardiol. 2013;28:389-398.
24. Davidson MH, Stein EA, Dujovne CA, Hunninghake DB, Weiss SR, Knopp RH, Illingworth DR, Mitchel YB, Melino MR, Zupkis RV, Dobrinska MR, Amin RD, Tobert JA. The efficacy and six-week tolerability of simvastatin 80 and 160 mg/day. Am J Cardiol. 1997;79:38-42.
25. Nissen SE. High-dose statins in acute coronary syndromes: not just lipid levels. JAMA. 2004;292:1365-1367.
26. Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001;88:504-508.