Lipid-Altering Efficacy of Ezetimibe/Simvastatin 10/20 mg Compared to Rosuvastatin 10 mg in High-Risk Patients with and without Type 2 Diabetes Mellitus Inadequately Controlled Despite Prior Statin Monotherapy

Cardiovascular Therapeutics

Volumn 30, Issue 2, 2012, Pages 61-74

  Vaverkova, Helena ^a   Farnier, Michel ^b   Averna, Maurizio ^c   Missault, Luc ^d   Viigimaa, Margus ^e   Dong, Qian ^f   Shah, Arvind ^f   Johnson Levonas, Amy O ^f   Brudi, Philippe ^g  

^a UNIVERSITY HOSPITAL OLOMOUC   (Czech Republic)

^b Point Medical Rond Point de la Nation   (France)

^c UNIVERSITY OF PALERMO   (Italy)

^d General Hospital St Jan   (Belgium)

^e TALLINN UNIVERSITY OF TECHNOLOGY   (Estonia)

^f MERCK RESEARCH LABORATORIES   (United States)

^g Merck/Schering Plough   (United States)

Author keywords

Coronary vascular disease; Hypercholesterolemia; Lipids; Type 2 diabetes

Indexed keywords

APOLIPOPROTEIN B; C REACTIVE PROTEIN; EZETIMIBE PLUS SIMVASTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN;

ADULT; ALLERGY; ARTICLE; CHOLANGITIS; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; GALLBLADDER DISEASE; GASTROINTESTINAL SYMPTOM; HEPATITIS; HIGH RISK PATIENT; HUMAN; HYPERCHOLESTEROLEMIA; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT;

ANTICHOLESTEREMIC AGENTS; APOLIPOPROTEINS B; AZETIDINES; C-REACTIVE PROTEIN; CHOLESTEROL; CHOLESTEROL, LDL; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG RESISTANCE; DRUG THERAPY, COMBINATION; FLUOROBENZENES; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERCHOLESTEROLEMIA; LIPIDS; ODDS RATIO; PYRIMIDINES; SIMVASTATIN; SULFONAMIDES;

EID: 84858265948     PISSN: 17555914     EISSN: 17555922     Source Type: Journal    
DOI: 10.1111/j.1755-5922.2010.00181.x     Document Type: Article

References (38)

1. Haffner SM. Dyslipidemia management in adults with diabetes. Diabetes Care 2004;27(Suppl 1):S68-S71.
2. Mooradian AD. Dyslipidemia in type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab 2009;5:150-159.
3. Solano MP, Goldberg RB. Management of dyslipidemia in diabetes. Cardiol Rev 2006;14:125-135.
4. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Executive summary of the third report of the National Cholesterol Education Program (NCEP). JAMA 2001;285:2486-2497.
5. Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, 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.
6. Grundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004;110:227-239.
7. Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: Executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007;28:88-136.
8. Baigent C, Keech A, Kearney PM, et al. 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.
9. Kearney PM, Blackwell L, Collins R, et al. Efficacy of cholesterol-lowering therapy in 18, 686 people with diabetes in 14 randomised trials of statins: A meta-analysis. Lancet 2008;371:117-125.
10. Lamarche B, Moorjani S, Lupien PJ, Cantin B, Bernard PM, Dagenais GR, Despres JP. Apolipoprotein A-I and B levels and the risk of ischemic heart disease during a five-year follow-up of men in the Quebec cardiovascular study. Circulation 1996;94:273-278.
11. Liu J, Sempos C, Donahue RP, Dorn J, Trevisan M, Grundy SM. Joint distribution of non-HDL and LDL cholesterol and coronary heart disease risk prediction among individuals with and without diabetes. Diabetes Care 2005;28:1916-1921.
12. Lu W, Resnick HE, Jablonski KA, et al. Non-HDL cholesterol as a predictor of cardiovascular disease in type 2 diabetes: The strong heart study. Diabetes Care 2003;26:16-23.
13. Pischon T, Girman CJ, Sacks FM, Rifai N, Stampfer MJ, Rimm EB. Non-high-density lipoprotein cholesterol and apolipoprotein B in the prediction of coronary heart disease in men. Circulation 2005;112:3375-3383.
14. Vaverkova H, Karasek D, Novotny D, Jackuliakova D, Lukes J, Halenka M, Frohlich J. Apolipoprotein B versus LDL-cholesterol: Association with other risk factors for atherosclerosis. Clin Biochem 2009;42:1246-1251.
15. Walldius G, Jungner I, Holme I, Aastveit AH, Kolar W, Steiner E. High apolipoprotein B, low apolipoprotein A-I, and improvement in the prediction of fatal myocardial infarction (AMORIS study): A prospective study. Lancet 2001;358:2026-2033.
16. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20, 536 high-risk individuals: A randomised placebo-controlled trial. Lancet 2002;360:7-22.
17. Collins R, Armitage J, Parish S, Sleigh P, 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.
18. Davidson MH, Maki KC, Pearson TA, et al. Results of the National Cholesterol Education (NCEP) Program Evaluation ProjecT Utilizing Novel E-Technology (NEPTUNE) II survey and implications for treatment under the recent NCEP Writing Group recommendations. Am J Cardiol 2005;96:556-563.
19. Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U. EUROASPIRE III: A survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil 2009;16:121-137.
20. Laforest L, Moulin P, Souchet T, et al. Correlates of LDL-cholesterol goal attainment in patients under lipid lowering therapy. Atherosclerosis 2008;199:368-377.
21. Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment project (L-TAP): A multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med 2000;160:459-467.
22. Farnier M, Averna M, Missault L, et al. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherap-The IN-CROSS study. Int J Clin Pract 2009;63:547-559.
23. Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350:1495-1504.
24. Cannon CP, Steinberg BA, Murphy SA, Mega JL, Braunwald E. Meta-analysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. J Am Coll Cardiol 2006;48:438-445.
25. de Lemos JA, Blazing MA, Wiviott SD, et al. 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.
26. LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-1435.
27. Pedersen TR, Faergeman O, Kastelein JJ, et al. 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.
28. Shepherd J, Barter P, Carmena R, et al. Effect of lowering LDL cholesterol substantially below currently recommended levels in patients with coronary heart disease and diabetes: The Treating to New Targets (TNT) study. Diabetes Care 2006;29:1220-1226.
29. Haffner SM, Lehto S, Ronnemaa T, Pyorala K, 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.
30. Laakso M, Voutilainen E, Sarlund H, Aro A, Pyorala K, Penttila I. Serum lipids and lipoproteins in middle-aged non-insulin-dependent diabetics. Atherosclerosis 1985;56:271-281.
31. Colhoun HM, Betteridge DJ, Durrington PN, et al. 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.
32. Lally S, Tan CY, Owens D, Tomkin GH. Messenger RNA levels of genes involved in dysregulation of postprandial lipoproteins in type 2 diabetes: The role of Niemann-Pick C1-like 1, ATP-binding cassette, transporters G5 and G8, and of microsomal triglyceride transfer protein. Diabetologia 2006;49:1008-1016.
33. Tomkin GH. The intestine as a regulator of cholesterol homeostasis in diabetes. Atheroscler Suppl 2008;9:27-32.
34. Santosa S, Varady KA, AbuMweis S, Jones PJ. Physiological and therapeutic factors affecting cholesterol metabolism: Does a reciprocal relationship between cholesterol absorption and synthesis really exist Life Sci 2007;80:505-514.
35. Simonen PP, Gylling HK, Miettinen TA. Diabetes contributes to cholesterol metabolism regardless of obesity. Diabetes Care 2002;25:1511-1515.
36. Gylling H, Miettinen TA. Cholesterol absorption and lipoprotein metabolism in type II diabetes mellitus with and without coronary artery disease. Atherosclerosis 1996;126:325-332.
37. Matthan NR, Pencina M, Larocque JM, Jacques PF, D'Agostino RB, Schaefer EJ, Lichtenstein AH. Alterations in cholesterol absorption and synthesis characterize Framingham offspring study participants with coronary heart disease. J Lipid Res 2009;50:1927-1935.
38. Simonen P, Gylling H, Miettinen TA. The validity of serum squalene and non-cholesterol sterols as surrogate markers of cholesterol synthesis and absorption in type 2 diabetes. Atherosclerosis 2008;197:883-888.