Effect of evolocumab on progression of coronary disease in statin-treated patients: The GLAGOV randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 316, Issue 22, 2016, Pages 2373-2384

  Nicholls, Stephen J ^a,b   Puri, Rishi ^b   Anderson, Todd ^c   Ballantyne, Christie M ^d   Cho, Leslie ^b   Kastelein, John J P ^e   Koenig, Wolfgang ^f,g,h   Somaratne, Ransi ⁱ   Kassahun, Helina ⁱ   Yang, Jingyuan ⁱ   Wasserman, Scott M ⁱ   Scott, Robert ⁱ   Ungi, Imre ^j   Podolec, Jakub ^k   Ophuis, Antonius Oude ^l   Cornel, Jan H ^m   Borgman, Marilyn ^b   Brennan, Danielle M ^b   Nissen, Steven E ^b  

^a UNIVERSITY OF ADELAIDE   (Australia)

^b LERNER RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF CALGARY   (Canada)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e UNIVERSITY OF AMSTERDAM   (Netherlands)

^f TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^g DZHK GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH   (Germany)

^h UNIVERSITY HOSPITAL ULM   (Germany)

ⁱ AMGEN INC   (United States)

^j UNIVERSITY OF SZEGED   (Hungary)

^k JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^l CANISIUS WILHELMINA HOSPITAL   (Netherlands)

^m Location Alkmaar   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATINE KINASE; CREATININE; EVOLOCUMAB; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NEUTRALIZING ANTIBODY; PLACEBO; PROPROTEIN CONVERTASE 9; MONOCLONAL ANTIBODY; PCSK9 PROTEIN, HUMAN;

ADULT; ARTICLE; ASIA; AUSTRALIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR PARAMETERS; CEREBROVASCULAR ACCIDENT; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; CORONARY ANGIOGRAPHY; CORONARY ARTERY ATHEROSCLEROSIS; DIABETES MELLITUS; DISEASE COURSE; DISORDERS OF HIGHER CEREBRAL FUNCTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENZYME INHIBITION; EUROPE; FEMALE; HEART INFARCTION; HUMAN; INJECTION SITE REACTION; INTRAVASCULAR ULTRASOUND; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NORTH AMERICA; OUTCOME ASSESSMENT; PERCENT ATHEROMA VOLUME; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOUTH AFRICA; SOUTH AMERICA; TOTAL ATHEROMA VOLUME; TREATMENT DURATION; UNSTABLE ANGINA PECTORIS; ANTAGONISTS AND INHIBITORS; BLOOD; CLINICAL TRIAL; CORONARY ARTERY DISEASE; DIAGNOSTIC IMAGING; ECHOGRAPHY; MIDDLE AGED; PATHOLOGY; PLACEBO EFFECT; PLAQUE, ATHEROSCLEROTIC; REMISSION; SUBCUTANEOUS DRUG ADMINISTRATION; TIME FACTOR;

ANTIBODIES, MONOCLONAL; CHOLESTEROL, LDL; CORONARY ANGIOGRAPHY; CORONARY ARTERY DISEASE; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; PLACEBO EFFECT; PLAQUE, ATHEROSCLEROTIC; PROPROTEIN CONVERTASE 9; REMISSION INDUCTION; TIME FACTORS; ULTRASONOGRAPHY;

EID: 85007568915     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2016.16951     Document Type: Article

References (31)

1. LaRosa JC, Grundy SM,Waters DD, et al; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352(14):1425-1435.
2. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists' (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: ameta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
3. Nicholls SJ, Ballantyne CM, Barter PJ, et al. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011;365(22):2078-2087.
4. Nicholls SJ, Tuzcu EM, Sipahi I, et al. Statins, high-density lipoprotein cholesterol, and regression of coronary atherosclerosis. JAMA. 2007;297(5): 499-508.
5. Nissen SE, Nicholls SJ, Sipahi I, et al; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: The ASTEROID trial. JAMA. 2006;295(13):1556-1565.
6. Nissen SE, Tuzcu EM, Schoenhagen P, et al; REVERSAL Investigators. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: A randomized controlled trial. JAMA. 2004;291(9): 1071-1080.
7. Abifadel M, VarretM, Rabès JP, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003;34(2):154-156.
8. Maxwell KN, Breslow JL. Adenoviral-mediated expression of Pcsk9 in mice results in a low-density lipoprotein receptor knockout phenotype. Proc Natl Acad Sci U S A. 2004;101(18):7100-7105.
9. Seidah NG, Benjannet S, Wickham L, et al. The secretory proprotein convertase neural apoptosis-regulated convertase 1 (NARC-1): liver regeneration and neuronal differentiation. Proc Natl Acad Sci U S A. 2003;100(3):928-933.
10. Robinson JG, Nedergaard BS, RogersWJ, et al; LAPLACE-2 Investigators. Effect 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 trial. JAMA. 2014;311(18):1870-1882.
11. Blom DJ, Hala T, Bolognese M, et al; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014; 370(19):1809-1819.
12. Puri R, Nissen SE, Somaratne R, et al. Impact of PCSK9 inhibition on coronary atheroma progression: rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016;176:83-92.
13. Nissen SE, Nicholls SJ,Wolski K, et al; PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: The PERISCOPE randomized controlled trial. JAMA. 2008;299(13):1561-1573.
14. Nissen SE, Nicholls SJ,Wolski K, et al; STRADIVARIUS Investigators. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: The STRADIVARIUS randomized controlled trial. JAMA. 2008;299(13):1547-1560.
15. Nissen SE, Tardif JC, Nicholls SJ, et al; ILLUSTRATE Investigators. Effect of torcetrapib on the progression of coronary atherosclerosis [published correction appears in N Engl J Med. 2007;357(8):835]. N Engl J Med. 2007;356(13): 1304-1316.
16. Nissen SE, Tsunoda T, Tuzcu EM, et al. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: A randomized controlled trial. JAMA. 2003;290(17):2292-2300.
17. Nissen SE, Tuzcu EM, Brewer HB, et al; ACAT Intravascular Atherosclerosis Treatment Evaluation (ACTIVATE) Investigators. Effect of ACAT inhibition on the progression of coronary atherosclerosis. N Engl J Med. 2006;354(12):1253-1263.
18. Nissen SE, Tuzcu EM, Libby P, et al; CAMELOT Investigators. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: The CAMELOT study: A randomized controlled trial. JAMA. 2004;292(18):2217-2225.
19. Nicholls SJ, Hsu A,Wolski K, et al. Intravascular ultrasound-derived measures of coronary atherosclerotic plaque burden and clinical outcome. J AmColl Cardiol. 2010;55(21):2399-2407.
20. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344(8934):1383-1389.
21. Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339(19):1349-1357.
22. Sacks FM, Pfeffer MA,Moye LA, et al; Cholesterol and Recurrent Events Trial Investigators. The effect of pravastatin on coronary events aftermyocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996;335 (14):1001-1009.
23. Shepherd J, Cobbe SM, Ford I, et al;West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333(20):1301-1307.
24. Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 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 AmColl Cardiol. 2014;63(25, pt B):2889-2934.
25. Catapano AL, Graham I, De Backer G, et al; Authors/Task Force Members. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR) [published online August 27, 2016]. Eur Heart J. doi: 10.1093/eurheartj/ehw272
26. Jones PH, Nair R, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: A retrospective analysis. J AmHeart Assoc. 2012;1 (6):e001800.
27. Libby P. The forgotten majority: unfinished business in cardiovascular risk reduction. J AmColl Cardiol. 2005;46(7):1225-1228.
28. Nissen SE, Stroes E, Dent-Acosta RE, et al; GAUSS-3 Investigators. Efficacy and tolerability of evolocumab vs ezetimibe in patients with muscle-related statin intolerance: The GAUSS-3 randomized clinical trial. JAMA. 2016;315(15):1580-1590.
29. Mayne J, Dewpura T, Raymond A, et al. Plasma PCSK9 levels are significantly modified by statins and fibrates in humans. Lipids Health Dis. 2008;7:22.
30. 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 AmColl Cardiol. 2005;46(8):1411-1416.
31. Puri R, Nissen SE, Shao M, et al. Coronary atheroma volume and cardiovascular events during maximally intensive statin therapy. Eur Heart J. 2013;34(41):3182-3190.