Rationale and design of the standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy (EMPATHY) study: A randomized controlled trial

Journal of Atherosclerosis and Thrombosis

Volumn 23, Issue 8, 2016, Pages 976-990

  Ueshima, Kenji ^a   Itoh, Hiroshi ^b   Kanazawa, Nobuaki ^c   Komuro, Issei ^d   Nagai, Ryozo ^e   Takeuchi, Masahiro ^f   Yamazaki, Tsutomu ^g  

^a KYOTO UNIVERSITY HOSPITAL   (Japan)

^b KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c SHIONOGI AND CO LTD   (Japan)

^d UNIVERSITY OF TOKYO   (Japan)

^e JICHI MEDICAL UNIVERSITY   (Japan)

^f KITASATO UNIVERSITY   (Japan)

^g UNIVERSITY OF TOKYO HOSPITAL   (Japan)

Author keywords

Diabetic retinopathy; Dyslipidemia; Hydroxymethylglutaryl CoA reductase inhibitors; Primary prevention; Randomized controlled trial

Indexed keywords

ATORVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PITAVASTATIN; ROSUVASTATIN;

ADULT; ARTICLE; BLOOD PRESSURE MONITORING; DIABETIC RETINOPATHY; FAMILIAL HYPERCHOLESTEROLEMIA; FEMALE; HOSPITAL ADMISSION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MONOTHERAPY; MORTALITY; OPHTHALMOSCOPY; PROSPECTIVE STUDY; REVASCULARIZATION; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED STUDY; EPIDEMIOLOGY; HYPERCHOLESTEROLEMIA; JAPAN; METABOLISM; MULTICENTER STUDY; PATHOPHYSIOLOGY; PREVALENCE; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL;

CHOLESTEROL, LDL; DIABETIC RETINOPATHY; EPIDEMIOLOGIC RESEARCH DESIGN; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERCHOLESTEROLEMIA; JAPAN; MALE; MIDDLE AGED; PREVALENCE; PROGNOSIS; PROSPECTIVE STUDIES;

EID: 84979988039     PISSN: 13403478     EISSN: 18803873     Source Type: Journal    
DOI: 10.5551/jat.33563     Document Type: Article

References (34)

1. Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, and Simes R; Cholesterol Treatment Trialists’ (CTT) Collaborators: Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet, 2005; 366: 1267-1278
2. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults: Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA, 2001; 285: 2486-2497
3. Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, and Witztum JL: Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American Diabetes Association and the American College of Cardiology Foundation. Diabetes Care, 2008; 31: 811-822
4. Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, and Laakso M: Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med, 1998; 339: 229-234
5. Nishimura T, Nakajima K, Kusuoka H, Yamashina A, and Nishimura S: Prognostic study of risk stratification among Japanese patients with ischemic heart disease using gated myocardial perfusion SPECT: J-ACCESS study. Eur J Nucl Med Mol Imaging, 2008; 35: 319-328
6. Turner RC, Millns H, Neil HA, Stratton IM, Manley SE, Matthews DR, and Holman RR: Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS: 23). BMJ, 1998; 316: 823-828
7. Kearney PM, Blackwell L, Collins R, Keech A, Simes J, Peto R, Armitage J, and Baigent C; Cholesterol Treatment Trialists’ (CTT) Collaborators: Efficacy of cholesterollowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet, 2008; 371: 117-125
8. Kramer CK, Rodrigues TC, Canani LH, Gross JL, and Azevedo MJ: Diabetic retinopathy predicts all-cause mortality and cardiovascular events in both type 1 and 2 Diabetes: meta-analysis of observational studies. Diabetes Care, 2011; 34: 1238-1244
9. Cheung N, Wang JJ, Klein R, Couper DJ, Sharrett AR, and Wong TY: Diabetic retinopathy and the risk of coronary heart disease: the Atherosclerosis Risk in Communities Study. Diabetes Care, 2007; 30: 1742-1746
10. Cheung N, Rogers S, Couper DJ, Klein R, Sharrett AR, and Wong TY: Is diabetic retinopathy an independent risk factor for ischemic stroke ? Stroke, 2007; 38: 398-401
11. Ohno T, Kinoshita O, Fujita H, Kato S, Hirose A, Sigeeda T, Otomo K, Ando J, Kadowaki T, Araie M, Nagai R, and Takamoto S: Detecting occult coronary artery disease followed by early coronary artery bypass surgery in patients with diabetic retinopathy: report from a diabetic retinocoronary clinic. J Thorac Cardiovasc Surg, 2010; 139: 92-97
12. Okazaki S, Yokoyama T, Miyauchi K, Shimada K, Kurata T, Sato H, and 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
13. Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, and 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
14. Takayama T, Hiro T, Yamagishi M, Daida H, Hirayama A, Saito S, Yamaguchi T, and Matsuzaki M: Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Circ J, 2009; 73: 2110-2117
15. Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, and Ohashi Y: Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Lancet, 2006; 368: 1155-1163
16. Sone H, Tanaka S, Tanaka S, Iimuro S, Oida K, Yamasaki Y, Oikawa S, Ishibashi S, Katayama S, Ohashi Y, Akanuma Y, and Yamada N: Serum level of triglycerides is a potent risk factor comparable to LDL cholesterol for coronary heart disease in Japanese patients with type 2 diabetes: subanalysis of the Japan Diabetes Complications Study (JDCS). J Clin Endocrinol Metab, 2011; 96: 3448-3456
17. Teramoto T, Sasaki J, Ueshima H, Egusa G, Kinoshita M, Shimamoto K, Daida H, Biro S, Hirobe K, Funahashi T, Yokote K, and Yokode M: Executive summary of Japan Atherosclerosis Society (JAS) guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese. J Atheroscler Thromb, 2007; 14: 45-50
18. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, and Wilson PW: 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 Am Coll Cardiol, 2014; 63: 2889-2934
19. Smith SC Jr, and Grundy SM: 2013 ACC/AHA guideline recommends fixed-dose strategies instead of targeted goals to lower blood cholesterol. J Am Coll Cardiol, 2014; 64: 601-612
20. The Japan Diabetes Society: Guideline for the diagnosis of diabetes mellitus. In: Evidence-based practice guidelines for the treatment of diabetes in Japan 3rd Ed, ed by The Japan Diabetes Society, pp13-19, Nankodo Co., Ltd, Tokyo, Japan, 2010 (in Japanese)
21. Ogihara T, Kikuchi K, Matsuoka H, Fujita T, Higaki J, Horiuchi M, Imai Y, Imaizumi T, Ito S, Iwao H, Kario K, Kawano Y, Kim-Mitsuyama S, Kimura G, Matsubara H, Matsuura H, Naruse M, Saito I, Shimada K, Shimamoto K, Suzuki H, Takishita S, Tanahashi N, Tsuchihashi T, Uchiyama M, Ueda S, Ueshima H, Umemura S, Ishimitsu T, and Rakugi H: The Japanese Society of Hypertension guidelines for the management of hypertension (JSH 2009). Hypertens Res, 2009; 32: 3-107
22. Ballantyne CM, and Nambi V: Markers of inflammation and their clinical significance. Atheroscler Suppl, 2005; 6: 21-29
23. Qu HY, Xiao YW, Jiang GH, Wang ZY, Zhang Y, and Zhang M: Effect of atorvastatin versus rosuvastatin on levels of serum lipids, inflammatory markers and adiponectin in patients with hypercholesterolemia. Pharm Res, 2009; 26: 958-964
24. Sandhu S, Wiebe N, Fried LF, and Tonelli M: Statins for improving renal outcomes: a meta-analysis. J Am Soc Nephrol, 2006; 17: 2006-2016
25. Koya D, and Campese VM: Statin use in patients with diabetes and kidney disease: the Japanese experience. J Atheroscler Thromb, 2013; 20: 407-424
26. Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, and Saito Y: Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA, 2008; 300: 2134-2141
27. Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, and Fuller JH: Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet, 2004; 364: 685-696
28. Sever PS, Poulter NR, Dahlöf B, Wedel H, Collins R, Beevers G, Caulfield M, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O’Brien E, and Ostergren J: Reduction in cardiovascular events with atorvastatin in 2,532 patients with type 2 diabetes: Anglo-Scandinavian Cardiac Outcomes Trial—lipid-lowering arm (ASCOT-LLA). Diabetes Care, 2005; 28: 1151-1157
29. Collins R, Armitage J, Parish S, Sleigh P, and Peto R: MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet, 2003; 361: 2005-2016
30. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, and Skene AM: Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med, 2004; 350: 1495-1504
31. de Lemos JA, Blazing MA, Wiviott SD, Lewis EF, Fox KA, White HD, Rouleau JL, Pedersen TR, Gardner LH, Mukherjee R, Ramsey KE, Palmisano J, Bilheimer DW, Pfeffer MA, Califf RM, and Braunwald E: Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA, 2004; 292: 1307-1316
32. LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, and Wenger NK: Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med, 2005; 352: 1425-1435
33. Pedersen TR, Faergeman O, Kastelein JJ, Olsson AG, Tikkanen MJ, Holme I, Larsen ML, Bendiksen FS, Lindahl C, Szarek M, and Tsai J: High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA, 2005; 294: 2437-2445
34. Armitage J, Bowman L, Wallendszus K, Bulbulia R, Rahimi K, Haynes R, Parish S, Peto R, and Collins R; Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group: Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Lancet, 2010; 376: 1658-1669