Effects of combination therapy with cilostazol and probucol versus monotherapy with cilostazol on coronary plaque, lipid and biomarkers: SECURE study, a double-blind randomized controlled clinical trial

Journal of Atherosclerosis and Thrombosis

Volumn 21, Issue 8, 2014, Pages 816-830

  Ko, Young Guk ^a   Choi, Seung Hyuk ^b   Kang, Woong Chol ^c   Lee, Byoung Kwon ^a   Kim, Sang Wook ^d   Shim, Won Heum ^a,e  

^a Yonsei University College of Medicine   (South Korea)

^b Samsung Medical Center   (South Korea)

^c Gachon University   (South Korea)

^d Chung Ang University College of Medicine   (South Korea)

^e Sejong General Hospital   (South Korea)

Author keywords

Atherosclerosis; Cilostazol; Coronary artery disease; Probucol

Indexed keywords

ACETYLSALICYLIC ACID; ALANINE AMINOTRANSFERASE; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; CILOSTAZOL; CLOPIDOGREL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LARGE LOW DENSITY LIPOPROTEIN; LIPID; LIPOPROTEIN A; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; OXIDIZED LOW DENSITY LIPOPROTEIN; PLACEBO; PROBUCOL; SIMVASTATIN; UNCLASSIFIED DRUG; ZOTAROLIMUS; AUTACOID; BIOLOGICAL MARKER; BRONCHODILATING AGENT; HYPOCHOLESTEROLEMIC AGENT; TETRAZOLE DERIVATIVE;

ACUTE CORONARY SYNDROME; ADULT; AGE; ANGIOGRAPHY; ARTICLE; BLURRED VISION; CARDIOVASCULAR DISEASE; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; CORONARY PLAQUE; DIABETES MELLITUS; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG ELUTING STENT; DRUG WITHDRAWAL; FEMALE; FIBROFATTY TISSUE; FIBROSIS; FOLLOW UP; HEADACHE; HEART MUSCLE CONDUCTION DISTURBANCE; HEART PALPITATION; HUMAN; HYPERPLASIA; IN-STENT RESTENOSIS; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; NEOINTIMAL HYPERPLASIA; PARTICLE SIZE; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; REMISSION; TISSUES; WEAKNESS; CLINICAL TRIAL; COMPARATIVE STUDY; CORONARY ARTERY DISEASE; DRUG COMBINATION; DRUG POTENTIATION; ECHOGRAPHY; ENDOSCOPIC ECHOGRAPHY; METABOLISM; MIDDLE AGED; PROGNOSIS;

ANTICHOLESTEREMIC AGENTS; BIOLOGICAL MARKERS; BRONCHODILATOR AGENTS; CORONARY ARTERY DISEASE; DOUBLE-BLIND METHOD; DRUG SYNERGISM; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFLAMMATION MEDIATORS; LIPIDS; MALE; MIDDLE AGED; PROBUCOL; PROGNOSIS; TETRAZOLES; ULTRASONOGRAPHY, INTERVENTIONAL;

EID: 84906821757     PISSN: 13403478     EISSN: 18803873     Source Type: Journal    
DOI: 10.5551/jat.22657     Document Type: Article

References (32)

1. Sawayama Y, Shimizu C, Maeda N, Tatsukawa M, Kinukawa N, Koyanagi S, Kashiwagi S, Hayashi J: Effects of probucol and pravastatin on common carotid atherosclerosis in patients with asymptomatic hypercholesterolemia. Fukuoka Atherosclerosis Trial (FAST). J Am Coll Cardiol, 2002; 39: 610-616
2. Yamashita S, Matsuzawa Y: Where are we with probucol: a new life for an old drug? Atherosclerosis, 2009; 207:16-23
3. Yamashita S, Hbujo H, Arai H, Harada-Shiba M, Matsui S, Fukushima M, Saito Y, Kita T, Matsuzawa Y: Longterm probucol treatment prevents secondary cardiovascular events: a cohort study of patients with heterozygous familial hypercholesterolemia in Japan. Journal of atherosclerosis and thrombosis, 2008; 15: 292-303
4. Franceschini G, Sirtori M, Vaccarino V, Gianfranceschi G, Rezzonico L, Chiesa G, Sirtori CR: Mechanisms of HDL reduction after probucol. Changes in HDL subfractions and increased reverse cholesteryl ester transfer. Arteriosclerosis, 1989; 9: 462-469
5. Ishigami M, Yamashita S, Sakai N, Hirano K, Arai T, Maruyama T, Takami S, Koyama M, Kameda-Takemura K, Matsuzawa Y: High-density lipoproteins from probucol-treated patients have increased capacity to promote cholesterol efflux from mouse peritoneal macrophages loaded with acetylated low-density lipoproteins. Eur J Clin Invest, 1997; 27: 285-292
6. Hirano K, Ikegami C, Tsujii K, Zhang Z, Matsuura F, Nakagawa-Toyama Y, Koseki M, Masuda D, Maruyama T, Shimomura I, Ueda Y, Yamashita S: Probucol enhances the expression of human hepatic scavenger receptor class B type I, possibly through a species-specific mechanism. Arterioscler Thromb Vasc Biol, 2005; 25: 2422-2427
7. Weintraub WS: The vascular effects of cilostazol. Can J Cardiol, 2006; 22 Suppl B: 56B-60B
8. Nakamura T, Houchi H, Minami A, Sakamoto S, Tsuchiya K, Niwa Y, Minakuchi K, Nakaya Y: Endothelium-dependent relaxation by cilostazol, a phosphodiesteras Ⅲ inhibitor, on rat thoracic aorta. Life Sci, 2001; 69: 1709-1715
9. Kim KY, Shin HK, Choi JM, Hong KW: Inhibition of lipopolysaccharide-induced apoptosis by cilostazol in human umbilical vein endothelial cells. J Pharmacol Exp Ther, 2002; 300: 709-715
10. Okutsu R, Yoshikawa T, Nagasawa M, Hirose Y, Takase H, Mitani K, Okada K, Miyakoda G, Yabuuchi Y: Cilostazol inhibits modified low-density lipoprotein uptake and foam cell formation in mouse peritoneal macrophages. Atherosclerosis, 2009; 204: 405-411
11. Ishizaka N, Taguchi J, Kimura Y, Ikari Y, Aizawa T, Togo M, Miki K, Kurokawa K, Ohno M: Effects of a single local administration of cilostazol on neointimal formation in balloon-injured rat carotid artery. Atherosclerosis, 1999; 142: 41-46
12. Tani T, Uehara K, Sudo T, Marukawa K, Yasuda Y, Kimura Y: Cilostazol, a selective type Ⅲ phosphodiesterase inhibitor, decreases triglyceride and increases HDL cholesterol levels by increasing lipoprotein lipase activity in rats. Atherosclerosis, 2000; 152: 299-305
13. Elam MB, Heckman J, Crouse JR, Hunninghake DB, Herd JA, Davidson M, Gordon IL, Bortey EB, Forbes WP: Effect of the novel antiplatelet agent cilostazol on plasma lipoproteins in patients with intermittent claudication. Arterioscler Thromb Vasc Biol, 1998; 18: 1942-1947
14. Yoshikawa T, Mitani K, Kotosai K, Nozako M, Miyakoda G, Yabuuchi Y: Antiatherogenic effects of cilostazol and probucol alone, and in combination in low density lipoprotein receptor-deficient mice fed with a high fat diet. Horm Metab Res, 2008; 40: 473-478
15. Park SY, Lee JH, Shin HK, Kim CD, Lee WS, Rhim BY, Shin YW, Hong KW: Synergistic efficacy of concurrent treatment with cilostazol and probucol on the suppression of reactive oxygen species and inflammatory markers in cultured human coronary artery endothelial cells. Korean J Physiol Pharmacol, 2008; 12: 165-170
16. Ko YG, Kim BK, Lee BK, Kang WC, Choi SH, Kim SW, Lee JH, Lee M, Honda Y, Fitzerald PJ, Shim WH: Study design and rationale of “Synergistic effect of combination therapy with cilostazol and ProbUcol on plaque stabilization and lesion REgression (SECURE)” study: a double-blind randomised controlled multicenter clinical trial. Trials, 2011; 12: 10
17. Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE, 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr,, 2011 Writing Group M, Accf/Aha Task Force M: ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation, 2011; 123: e426-579
18. Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE: Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med, 2011; 365: 2078-2087
19. Okazaki S, Yokoyama T, Miyauchi K, Shimada K, Kurata T, Sato H, Daida H: Early statin treatment in patients with acute coronary syndrome: demonstration of the beneficial effect on atherosclerotic lesions by serial volumetric intravascular ultrasound analysis during half a year after coronary event: the ESTABLISH Study. Circulation, 2004; 110: 1061-1068
20. Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M: Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J Am Coll Cardiol, 2009; 54: 293-302
21. Choi SH, Chae A, Miller E, Messig M, Ntanios F, DeMaria AN, Nissen SE, Witztum JL, Tsimikas S: Relationship between biomarkers of oxidized low-density lipoprotein, statin therapy, quantitative coronary angiography, and atheroma: volume observations from the REVERSAL (Reversal of Atherosclerosis with Aggressive Lipid Lowering) study. J Am Coll Cardiol, 2008; 52: 24-32
22. Tsimikas S, Tsironis LD, Tselepis AD: New insights into the role of lipoprotein(a)-associated lipoprotein-associated phospholipase A2 in atherosclerosis and cardiovascular disease, Arterioscler Thromb Vasc Biol 2007; 27: 2094- 2099
23. Naruszewicz M, Selinger E, Dufour R, Davignon J: Probucol protects lipoprotein (a) against oxidative modification. Metabolism, 1992; 41: 1225-1228
24. Bird DA, Tangirala RK, Fruebis J, Steinberg D, Witztum JL, Palinski W: Effect of probucol on LDL oxidation and atherosclerosis in LDL receptor-deficient mice. J Lipid Res, 1998; 39: 1079-1090
25. Fruebis J, Gonzalez V, Silvestre M, Palinski W: Effect of probucol treatment on gene expression of VCAM-1, MCP-1, and M-CSF in the aortic wall of LDL receptordeficient rabbits during early atherogenesis. Arterioscler Thromb Vasc Biol, 1997; 17: 1289-1302
26. Lau AK, Leichtweis SB, Hume P, Mashima R, Hou JY, Chaufour X, Wilkinson B, Hunt NH, Celermajer DS, Stocker R: Probucol promotes functional reendothelialization in balloon-injured rabbit aortas. Circulation, 2003; 107: 2031-2036
27. Miida T, Seino U, Miyazaki O, Hanyu O, Hirayama S, Saito T, Ishikawa Y, Akamatsu S, Nakano T, Nakajima K, Okazaki M, Okada M: Probucol markedly reduces HDL phospholipids and elevated prebeta1-HDL without delayed conversion into alpha-migrating HDL: putative role of angiopoietin-like protein 3 in probucol-induced HDL remodeling. Atherosclerosis, 2008; 200: 329-335
28. Miida T, Yamaguchi T, Tsuda T, Okada M: High prebeta1-HDL levels in hypercholesterolemia are maintained by probucol but reduced by a low-cholesterol diet. Atherosclerosis, 1998; 138: 129-134
29. Colvin PL, Parks JS: Metabolism of high density lipoprotein subfractions. Curr Opin Lipidol, 1999; 10: 309-314
30. Nakaya K, Ayaori M, Uto-Kondo H, Hisada T, Ogura M, Yakushiji E, Takiguchi S, Terao Y, Ozasa H, Sasaki M, Komatsu T, Ohsuzu F, Ikewaki K: Cilostazol enhances macrophage reverse cholesterol transport in vitro and in vivo. Atherosclerosis, 2010; 213: 135-141
31. Tardif JC, Cote G, Lesperance J, Bourassa M, Lambert J, Doucet S, Bilodeau L, Nattel S, de Guise P:, Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group. N Engl J Med, 1997; 337: 365-372
32. Sekiya M, Funada J, Watanabe K, Miyagawa M, Akutsu H: Effects of probucol and cilostazol alone and in combination on frequency of poststenting restenosis. Am J Cardiol, 1998; 82: 144-147