RESEARCH (Recognized effect of Statin and ezetimibe therapy for achieving LDL-C Goal), a randomized, doctor-oriented, multicenter trial to compare the effects of higher-dose statin versus ezetimibe-plus-statin on the serum LDL-C concentration of Japanese type-2 diabetes patients design and rationale

Lipids in Health and Disease

Volumn 12, Issue 1, 2013, Pages

  Inazawa, Takeshi ^a   Sakamoto, Kentaro ^b   Kohro, Takahide ^c   Iijima, Raisuke ^b   Kitazawa, Toru ^d   Hirano, Tsutomu ^e   Kawamura, Mitsunobu ^f   Tagami, Motoki ^g   Tanaka, Akira ^h   Mori, Yasumichi ⁱ   Yamazaki, Tsutomu ^j   Shiba, Teruo ^b,k  

^a Kashiwa Hospital   (Japan)

^b TOHO UNIVERSITY OHASHI MEDICAL CENTER   (Japan)

^c JICHI MEDICAL UNIVERSITY   (Japan)

^d JAPANESE RED CROSS MEDICAL CENTER   (Japan)

^e SHOWA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f TOKYO TEISHIN HOSPITAL   (Japan)

^g University of Tokyo   (Japan)

^h KAGAWA NUTRITION UNIVERSITY   (Japan)

ⁱ TORANOMON HOSPITAL   (Japan)

^j UNIVERSITY OF TOKYO HOSPITAL   (Japan)

^k MITSUI MEMORIAL HOSPITAL   (Japan)

more..

Author keywords

Ezetimibe; Hypercholesterolemia; Statin

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALPHA GLUCOSIDASE INHIBITOR; APOLIPOPROTEIN B; ATORVASTATIN; BIGUANIDE; C REACTIVE PROTEIN; CHOLESTEROL; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EZETIMIBE; GLINIDE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ORAL ANTIDIABETIC AGENT; PITAVASTATIN; REMNANT LIKE PARTICLE CHOLESTEROL; SMALL DENSE LOW DENSITY LIPOPROTEIN; SULFONYLUREA; TRIACYLGLYCEROL; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DIABETIC PATIENT; DISEASE ASSOCIATION; DRUG EFFICACY; DRUG MEGADOSE; FEMALE; FOLLOW UP; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERCHOLESTEROLEMIA; JAPANESE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; OUTPATIENT; PARALLEL DESIGN; PHYSICIAN; PREDICTIVE VALUE; PROSPECTIVE STUDY; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL;

AGE FACTORS; AGED; ANTICHOLESTEREMIC AGENTS; APOLIPOPROTEINS B; AZETIDINES; CHOLESTEROL, LDL; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPERCHOLESTEROLEMIA; MALE; MIDDLE AGED; SEX FACTORS; SIMVASTATIN;

EID: 84884956153     PISSN: None     EISSN: 1476511X     Source Type: Journal    
DOI: 10.1186/1476-511X-12-142     Document Type: Article

References (30)

1. Ministry of Health, Labor and Welfare (Japan). Report of National Health and Nutrition Surveillance 2010
2. Serum level of triglycerides is a potent risk factor comparable to LDL cholesterol for coronary heart disease in Japanese patients with type 2 diabetes: sub analysis of the Japan diabetes complications study (JDCS). Sone H, Tanaka S, Japan Diabetes Complications Study Group, et al. J Clin Endocrinol Metab 2011 96 3448 56 10.1210/jc.2011-0622 21865372
3. Impact of glucose tolerance status on development of ischemic stroke and coronary heart disease in a general Japanese population: the Hisayama study. Doi Y, Ninomiya T, Hata J, et al. Stroke 2010 41 203 9 10.1161/STROKEAHA.109.564708 19940278
4. Primary prevention of cardiovascular disease with Pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Nakamura H, Arakawa K, MEGA Study Group, et al. Lancet 2006 368 1155 63 10.1016/S0140-6736(06)69472-5 17011942 (Pubitemid 44444932)
5. MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Heart Protection Study Collaborative Group, Lancet 2002 360 9326 7 22 12114036
6. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian cardiac outcomes trial-lipid lowering arm (ASCOT-LLA): a multicentre randomised controlled trial. Sever PS, Dahlof B, Poulter NR, Wedel H, Beevers G, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, ASCOT investigators, et al. Lancet 2003 361 1149 1158 10.1016/S0140-6736(03)12948-0 12686036 (Pubitemid 36398384)
7. Prevention of cardiovascular events and death with Pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group, N Engl J Med 1998 339 1349 1357 9841303
8. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Cholesterol Treatment Trialists' (CTT) Collaboration, Lancet 2010 376 1670 81 10.1016/S0140-6736(10)61350-5 21067804
9. Niemann-Pick C1 like 1 protein is critical for intestinal cholesterol absorption. Altmann SW, Davis HR Jr, Zhu LJ, et al. Science 2004 303 1201 4 10.1126/science.1093131 14976318 (Pubitemid 38233587)
10. The target of ezetimibe is Niemann-Pick C1-Like 1 (NPC1L1). Garcia-Calvo M, Lisnock J, Bull HG, et al. Proc Natl Acad Sci USA 2005 102 8132 7 10.1073/pnas.0500269102 15928087 (Pubitemid 40800055)
11. Ezetimibe therapy: mechanism of action and clinical update. Phan BA, Dayspring TD, Toth PP, Vasc Health Risk Manag 2012 8 415 27 22910633
12. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of heart and renal protection): a randomised placebo-controlled trial. Baigent C, Landray MJ, Reith C, et al. Lancet 2011 377 2181 2192 10.1016/S0140-6736(11)60739-3 21663949
13. UMIN-CTR https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function= brows&action=brows&ty pe=summary&recptno=R000003155&language=J
14. Diagnostic criteria for dyslipidemia. Executive summary of Japan Atherosclerosis Society (JAS) guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese. Teramoto T, Sasaki J, Japan Atherosclerosis Society (JAS) Committee for Epidemiology and Clinical Management of Atherosclerosis, et al, et al. J Atheroscler Thromb 2007 14 155 8 10.5551/jat.E537 17827859
15. Clinical significance of small dense low-density lipoprotein cholesterol levels determined by the simple precipitation method. Hirano T, Ito Y, Koba S, Toyoda M, et al. Arterioscler Thromb Vasc Biol 2004 24 558 63 10.1161/01.ATV.0000117179.92263.08 14726414 (Pubitemid 38326153)
16. Ezetimibe co administered with simvastatin in patients with primary hypercholesterolemia. Davidson MH, McGarry T, Bettis R, et al. J Am Coll Cardiol 2002 40 2125 2134 10.1016/S0735-1097(02)02610-4 12505224 (Pubitemid 36005898)
17. Effects of ezetimibe co administered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Ballantyne CM, Houri J, Notarbartolo A, et al. Circulation 2003 107 2409 2415 10.1161/01.CIR.0000068312.21969.C8 12719279 (Pubitemid 36605221)
18. Efficacy and safety of ezetimibe co administered with lovastatin in primary hypercholesterolemia. Kerzner B, Corbelli J, Sharp S, et al. Am J Cardiol 2003 91 418 424 10.1016/S0002-9149(02)03236-8 12586255 (Pubitemid 36183559)
19. Efficacy and safety of ezetimibe co-administered with Pravastatin in patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Melani L, Mills R, Hassman D, et al. Eur Heart J 2003 24 717 728 12713766 (Pubitemid 36458984)
20. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom prospective diabetes study (UKPDS: 23). Turner RC, Millns H, Neil HA, et al. BMJ 1998 316 7134 823 8 10.1136/bmj.316.7134.823 9549452 (Pubitemid 28112428)
21. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Stark Casagrande S, Fradkin JE, Saydah SH, et al. Diabetes Care 2013 36 8 2271 9 10.2337/dc12-2258 23418368
22. The current status of medicinal therapy for hyperlipidemia-Kanazawa lipid assessment survey (K-LAS) [in Japanese]. Mabuchi YH, Inazu A, Higashikata T, et al. Prog Med 2000 20 1629 1639
23. Efficacy and safety of ezetimibe co-administered with simvastatin in thiazolidinedione-treated type 2 diabetic patients. Gaudiani LM, Lewin A, Meneghini L, et al. Diabetes Obes Metab 2005 7 88 97 10.1111/j.1463-1326.2004. 00420.x 15642080
24. Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics: a multicenter, randomized trial (the LEAD study). Bardini G, Giorda CB, Pontiroli AE, et al. Cardiovasc Diabetol 2010 9 20 10.1186/1475-2840-9-20 20492655
25. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Conard S, Bays H, Leiter LA, et al. Diabetes Obes Metab 2010 12 210 8 10.1111/j.1463-1326.2009.01152.x 20151997
26. Atorvastatin 10 mg plus ezetimibe 10mg compared with atorvastatin 20 mg: impact on the lipid profile in Japanese patients with abnormal glucose tolerance and coronary artery disease. Uemura Y, Watarai M, Ishii H, et al. J Cardiol 2012 59 50 6 10.1016/j.jjcc.2011.09.001 22100058
27. Small dense LDL: an emerging risk factor for cardiovascular disease. Hirayama S, Miida T, Clin Chim Acta 2012 414 215 24 22989852
28. Remnant cholesterol as a causal risk factor for ischemic heart disease. Varbo A, Benn M, Tybjærg-Hansen A, et al. J Am College Cardiol 2013 61 427 36 10.1016/j.jacc.2012.08.1026
29. Comparative study between high-dose Fluvastatin and low-dose Fluvastatin and ezetimibe with regard to the effect on endothelial function in diabetic patients. Kawagoe Y, Hattori Y, Nakano A, et al. Endocr J 2011 58 171 5 10.1507/endocrj.K10E-289 21304215
30. Small dense LDL: risk factor for coronary artery disease (CAD) and its therapeutic modulation. Sharma SB, Garg S, Indian J Biochem Biophys 2012 49 77 85 22650003