Efficacy and safety of a novel oral inducer of apolipoprotein A-I synthesis in statin-treated patients with stable coronary artery disease: A randomized controlled trial

Journal of the American College of Cardiology

Volumn 57, Issue 9, 2011, Pages 1111-1119

  Nicholls, Stephen J ^a   Gordon, Allan ^b   Johansson, Jan ^b   Wolski, Kathy ^a   Ballantyne, Christie M ^c   Kastelein, John J P ^d   Taylor, Allen ^e   Borgman, Marilyn ^a   Nissen, Steven E ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

^b Resverlogix Corp   (Canada)

^c BAYLOR COLLEGE OF MEDICINE   (United States)

^d ACADEMIC MEDICAL CENTER   (Netherlands)

^e WASHINGTON HOSPITAL CENTER   (United States)

Author keywords

apoA I; coronary artery disease; high density lipoprotein; prevention; risk factors

Indexed keywords

ALANINE AMINOTRANSFERASE; AMINOTRANSFERASE; APOLIPOPROTEIN A1; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BIOLOGICAL MARKER; CHOLESTEROL; CREATINE KINASE; CREATININE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT; LIPID; LIVER ENZYME; PLACEBO; RVX 208; UNCLASSIFIED DRUG;

AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHOLESTEROL TRANSPORT; CORONARY ARTERY DISEASE; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE;

AGED; APOLIPOPROTEIN A-I; CHOLESTEROL, HDL; CORONARY ARTERY DISEASE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; PROSPECTIVE STUDIES; QUINAZOLINES; TREATMENT OUTCOME;

EID: 79952005101     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2010.11.015     Document Type: Article

References (31)

1. P. Libby The forgotten majority: unfinished business in cardiovascular risk reduction J Am Coll Cardiol 46 2005 1225 1228 (Pubitemid 41615541)
2. T. Gordon, W.P. Castelli, M.C. Hjortland, W.B. Kannel, and T.R. Dawber High-density lipoprotein as a protective factor against coronary heart disease The Framingham Study Am J Med 62 1977 707 714 (Pubitemid 8110784)
3. J.J. Badimon, L. Badimon, A. Galvez, R. Dische, and V. Fuster High density lipoprotein plasma fractions inhibit aortic fatty streaks in cholesterol-fed rabbits Lab Invest 60 1989 455 461 (Pubitemid 19095962)
4. E.M. Rubin, R.M. Krauss, E.A. Spangler, J.G. Verstuyft, and S.M. Clift Inhibition of early atherogenesis in transgenic mice by human apolipoprotein AI Nature 353 1991 265 267 (Pubitemid 21896769)
5. S.E. Nissen, T. Tsunoda, and E.M. Tuzcu Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial JAMA 290 2003 2292 2300 (Pubitemid 37430562)
6. J.C. Tardif, J. Gregoire, and P.L. L'Allier Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial JAMA 297 2007 1675 1682 (Pubitemid 46631626)
7. R. Waksman, R. Torguson, and K.M. Kent A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome J Am Coll Cardiol 55 2010 2727 2735
8. P.J. Barter, S. Nicholls, K.A. Rye, G.M. Anantharamaiah, M. Navab, and A.M. Fogelman Antiinflammatory properties of HDL Circ Res 95 2004 764 772 (Pubitemid 39390578)
9. D. Bailey, R. Jahagirdar, and A. Gordon RVX-208: a small molecule that increases apolipoprotein A-I and high-density lipoprotein cholesterol in vitro and in vivo J Am Coll Cardiol 55 2010 2580 2589
10. B.F. Asztalos, L.A. Cupples, and S. Demissie High-density lipoprotein subpopulation profile and coronary heart disease prevalence in male participants of the Framingham Offspring Study Arterioscler Thromb Vasc Biol 24 2004 2181 2187 (Pubitemid 39482449)
11. S. Mora, J.D. Otvos, N. Rifai, R.S. Rosenson, J.E. Buring, and P.M. Ridker Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women Circulation 119 2009 931 939
12. P.J. Barter Hugh Sinclair lecture: the regulation and remodelling of HDL by plasma factors Atherosclerosis Suppl 3 2002 39 47 (Pubitemid 38234485)
13. H.B. Brewer Jr., and S. Santamarina-Fojo New insights into the role of the adenosine triphosphate-binding cassette transporters in high-density lipoprotein metabolism and reverse cholesterol transport Am J Cardiol 91 2003 3E 11E (Pubitemid 36385069)
14. K.A. Rye, and P.J. Barter Formation and metabolism of prebeta-migrating, lipid-poor apolipoprotein A-I Arterioscler Thromb Vasc Biol 24 2004 421 428 (Pubitemid 38326133)
15. H.B. Rubins, S.J. Robins, and D. Collins Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group N Engl J Med 341 1999 410 418 (Pubitemid 29362514)
16. S.J. Nicholls, E.M. Tuzcu, and I. Sipahi Statins, high-density lipoprotein cholesterol, and regression of coronary atherosclerosis JAMA 297 2007 499 508 (Pubitemid 46220805)
17. V.G. Athyros, D.P. Mikhailidis, and A.A. Papageorgiou Effect of atorvastatin on high density lipoprotein cholesterol and its relationship with coronary events: a subgroup analysis of the GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) study Curr Med Res Opin 20 2004 627 637 (Pubitemid 38685006)
18. Y. Cui, D.J. Watson, and C.J. Girman Effects of increasing high-density lipoprotein cholesterol and decreasing low-density lipoprotein cholesterol on the incidence of first acute coronary events (from the Air Force/Texas Coronary Atherosclerosis Prevention Study) Am J Cardiol 104 2009 829 834
19. K. El Harchaoui, B.J. Arsenault, and R. Franssen High-density lipoprotein particle size and concentration and coronary risk Ann Intern Med 150 2009 84 93
20. B.F. Asztalos High-density lipoprotein metabolism and progression of atherosclerosis: new insights from the HDL Atherosclerosis Treatment Study Curr Opin Cardiol 19 2004 385 391 (Pubitemid 38916499)
21. P.J. Barter, M. Caulfield, and M. Eriksson Effects of torcetrapib in patients at high risk for coronary events N Engl J Med 357 2007 2109 2122 (Pubitemid 350146106)
22. S.E. Nissen, S.J. Nicholls, and K. Wolski Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial JAMA 299 2008 1547 1560 (Pubitemid 351482794)
23. A.J. Taylor, T.C. Villines, and E.J. Stanek Extended-release niacin or ezetimibe and carotid intima-media thickness N Engl J Med 361 2009 2113 2122
24. S.S. Bhardwaj, and N. Chalasani Lipid-lowering agents that cause drug-induced hepatotoxicity Clin Liver Dis 11 2007 597 613 (Pubitemid 47304463)
25. B.J. Ansell, M. Navab, and S. Hama Inflammatory/antiinflammatory properties of high-density lipoprotein distinguish patients from control subjects better than high-density lipoprotein cholesterol levels and are favorably affected by simvastatin treatment Circulation 108 2003 2751 2756 (Pubitemid 37498976)
26. W.A. van der Steeg, I. Holme, and S.M. Boekholdt High-density lipoprotein cholesterol, high-density lipoprotein particle size, and apolipoprotein A-I: significance for cardiovascular risk: the IDEAL and EPIC-Norfolk studies J Am Coll Cardiol 51 2008 634 642 (Pubitemid 351186873)
27. M. de la Llera-Moya, D. Drazul-Schrader, B.F. Asztalos, M. Cuchel, D.J. Rader, and G.H. Rothblat The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages Arterioscler Thromb Vasc Biol 30 2010 796 801
28. S.J. Nicholls, P. Lundman, and J.A. Harmer Consumption of saturated fat impairs the anti-inflammatory properties of high-density lipoproteins and endothelial function J Am Coll Cardiol 48 2006 715 720 (Pubitemid 44175720)
29. A. Kontush, P. Therond, and A. Zerrad Preferential sphingosine-1- phosphate enrichment and sphingomyelin depletion are key features of small dense HDL3 particles: relevance to antiapoptotic and antioxidative activities Arterioscler Thromb Vasc Biol 27 2007 1843 1849 (Pubitemid 47207181)
30. B. Angelin, P. Parini, and M. Eriksson Reverse cholesterol transport in man: promotion of fecal steroid excretion by infusion of reconstituted HDL Atheroscler Suppl 3 2002 23 30 (Pubitemid 38234483)
31. P.M. Ridker, J. Genest, and S.M. Boekholdt HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial Lancet 376 2010 333 339