Статья
Комбинированная липид-корригирующая терапия: выбор стратегии и тактики
Достижение целевых уровней холестерина липопротеидов низкой плотности (ХС ЛНП) при использовании липид-корригирующей терапии — основное направление в снижении риска сердечно-сосудистых осложнений и смертности согласно российским и международным рекомендациям. Холестерин липопротеидов высокой плотности и триглицериды рассматриваются как вторичные цели при назначении гиполипидемических препаратов. Монотерапия статинами даже в высоких дозах и назначение других холестерин-снижающих средств позволяют достичь целевого уровня ХС ЛНП лишь в 30-50 % случаев. Анализ ряда опубликованных исследований показал, что для достижения целевых уровней ХС ЛНП более эффективно добавлять к статину дополнительное липид-корригирующее средство или назначать фиксированную комбинированную холестерин-снижающую терапию. Максимальное снижение ХС ЛНП обеспечивается при дополнительном назначении к статину эзетимиба или при использовании фиксированной комбинации — симвастатин 20 мг и эзетимиб 10 мг в одной таблетке. В зависимости от клинической ситуации рассмотрены особенности назначения комбинированной липид-корригирующей терапии согласно существующим рекомендациям. Для достижения высокой приверженности больных холестерин-снижающим препаратам необходимо с пациентами обсуждать и рассчитывать их сердечно-сосудистый риск.
1. National Cholesterol Education Program. 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): Final Report. Circulation 2002; 106: 3143-421.
2. Grundy SM, Cleeman JI, Merz CN, et al. National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004; 110: 227-39.
3. Buse JB, Nicolucci A, De Berardis G, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association: response to Buse et al. Diabetes Care 2007; 30: 162-72.
4. Standards of medical care in diabetes – 2008. Diabetes Care 2008; 31(Suppl 1): S12-54.
5. Brunzell JD, Davidson M, Furberg CD, et al. 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: 811-22.
6. Graham I, Atar D, Borch-Johnsen K, et al. European guidelines on cardiovascular disease prevention in clinical practice: full text. Fourth Joint Task Force of the European Society of Cardiology and other societies. Eur J Cardiovasc Prev Rehabil 2007;14(Suppl 2): S1-113.
7. Ryden L, Standl E, Bartnik M, et al; Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC); European Association for the Study of Diabetes (EASD). 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. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. ВНОК. Клинические рекомендации 2009. Формат: DOC. Качество: OCR.
9. Briel M, Ferreira-Gonzalez I, You JJ, et al. Association between change in high density lipoprotein cholesterol and cardiovascular disease morbidity and mortality: systematic review and metaregression analysis. BMJ 2009; 338: a3065, b92.
10. Sharrett AR, Ding J, Criqui MH, et al. Smoking, diabetes, and blood cholesterol differ in their associations with subclinical atherosclerosis: the Multiethnic Study of Atherosclerosis (MESA). Atheroscler 2006; 186: 441-7.
11. Faergeman O, Holme I, Fayyad R, et al. Plasma triglycerides and cardiovascular events in the Treating to New Targets and Incremental Decrease in End-Points through Aggressive Lipid Lowering trials of statins in patients with coronary artery disease. Am J Cardiol 2009; 104(4): 459-63.
12. Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA 2007; 298(3): 299-308.
13. Bansal S, Buring JE, Rifai N, et al. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA 2007; 298(3): 309-16.
14. Arima H, Yonemoto K, Doi Y, et al. Development and validation of a cardiovascular risk prediction model for Japanese: the Hisayama study. Hypertens Res 2009; 32(12): 1119-22.
15. LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA 1999; 282: 2340-6.
16. Национальные клинические рекомендации. Сборник. Под ред. Р. Г. Оганова. 2-е издание. Москва, изд-во “Силицея-Полиграф” 2009; 528 с.
17. Van Ganse E, Laforest L, Alemao E, et al. Lipid-modifying therapy and attainment of cholesterol goals in Europe: the Return on Expenditure Achieved for Lipid Therapy (REALITY) study. Curr Med Res Opin 2005; 21(9): 1389-99.
18. Susekov A, Zubareva M, Deev A, et al. Main results of Moscow Statins Study (Moscow Statin Survey, MSS). Heart (Serdtse) 2006; 5(6): 324-8.
19. Alsheikh-Ali AA, Lin JL, Abourjaily P, et al. Extent to which accepted serum lipid goals are achieved in a contemporary general medical population with coronary heart disease risk equivalents. Am J Cardiol 2006; 98(9): 1231-3.
20. Goff DCJr, Bertoni AG, Kramer H, et al. Dyslipidemia prevalence, treatment, and control in the Multi-Ethnic Study of Atherosclerosis (MESA): gender, ethnicity, and coronary artery calcium. Circulation 2006; 113: 647-56.
21. Chou AF, Wong L, Weisman CS, et al. Gender disparities in cardiovascular disease care among commercial and medicare managed care plans. Womens Health Issues 2007; 17(3): 139-49.
22. Gitt AK, Drexel H, Feely J, et al. High Prevalence of Persistent Lipid Abnormalities in High-Risk Patients Treated With Statins in Europe and Canada: Results of the Dyslipidemia International Study For the DYSIS-Study-Group. Institut f. Herzinfarktforschung Ludwigshafen an der Universit t Heidelberg. Germany 2009. Abstract.
23. Knopp RH. Drug treatment of lipid disorders. N Engl J Med 1999; 341: 498-509.
24. Jones PH, Davidson MH, Stein EA, et al. for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR trial). Am J Cardiol 2003; 92: 152-60.
25. Brewer B. Benefit-risk assessment of Rosuvastatin 10 to 40 milligrams. Am J Cardiol 2003; 92: 23K-9.
26. LaRosa JC, Grundy SM, Waters DD, et al. for the Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352: 1425-35.
27. www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.
28. Gagné C, Bays HE, Weiss SR, et al. for the Ezetimibe Study Group. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol 2002; 90: 1084-91.
29. Stalenhoef AF, Ballantyne CM, Sarti C, et al. A comparative study with rosuvastatin in subjects with metabolic syndrome: results of the COMETS study. Eur Heart J 2005; 26(24): 2664-72.
30. Barrios V, Amabile N, Paganelli F, et al. Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Int J Clin Pract 2005; 59(12): 1377-86.
31. Constance C, Westphal S, Chung N, et al. Efficacy of ezetimibe/ simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2007; 9(4): 575-84.
32. 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 monotherapy – The IN-CROSS study. Int J Clin Pract 2009; 63(4): 547-59.
33. Grundy SM, Vega GL, Yuan Z, et al. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol 2005; 95: 462-8.
34. Davidson MH, Stein EA, Bays HE et al. COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebocontrolled study. Clin Ther 2007; 29(7): 1354-67.
35. Bays HE, Dujovne CA, McGovern ME, et al. Comparison of once-daily, niacin extended-release/lovastatin with standard doses of atorvastatin and simvastatin (the ADvicor Versus Other Cholesterol-Modulating Agents Trial Evaluation). Am J Cardiol 2003; 91: 667-72.
36. Vittone F, Chait A, Morse JS, et al. Niacin plus simvastatin reduces coronary stenosis progression among patients with metabolic syndrome despite a modest increase in insulin resistance: A subgroup analysis of the HDL-Atherosclerosis Treatment Study (HATS). J Clin Lipidol 2007; 1: 203-10.
37. Greenland P, Lloyd-Jones D. Critical lessons from the ENHANCE trial. JAMA 2008; 299(8): 953-5.
38. Fleg JL, Mete M, Howard BV, et al. Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes. The SANDS (Stop Atherosclerosis in Native Diabetics Study) trial. JACC 2008; 52: 2198-205.
39. Davidson MH, Catapano AL, Ballantyne CM, et al. Attainment of optimal NCEP ATP III treatment goals in high-risk patients: dose comparison of ezetimibe/simvastatin and rosuvastatin. Atherosclerosis 2006; 7(Suppl): 555.
40. Ballantyne CM, Sosef F, Duffield E, et al. the EXPLORER study investigators. Efficacy and safety of rosuvastatin plus ezetimibe in high risk patients: results from the EXPLORER study. Atherosclerosis 2006; 7(Suppl): 552.
41. Ballantyne CM, Davidson MH, McKenney J, et al. Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I study). Am J Cardiol 2008; 101: 1428-36.
42. Taylor AJ, Villines TC, Stanek EJ, et al. Extended-release niacin or ezetimibe and carotid intima-media thickness. N Engl J Med 2009; 361(22): 2113-22.
43. Farnier M, Roth E, Gil-Extremera B, et al. Efficacy and safety of co-administered ezetimibe/simvastatin and fenofibrate in patients with mixed hyperlipidemia. Atherosclerosis 2006; 7(Suppl):174.
44. Kastelein JJ, Akdim F, Stroes ES, et al. ENHANCE Investigators. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008; 358(14): 1431-43.
45. Blumenthal RS, Michos ED. The HALTS trials--halting atherosclerosis or halted too early? N Engl J Med 2009; 361: 2178-80.
46. Sharma K, Blaha MJ, Blumenthal RS, Musunuru K. Clinical and research applications of carotid intima-media thickness. Am J Cardiol 2009; 103: 1316-20.
47. Finn AV, Kolodgie FD, Virmani R. Correlation between carotid intimal/medial thickness and atherosclerosis: a point of view from pathology. Arterioscler Thromb Vasc Biol 2010; 30(2):177-81.
48. Mackinnon AD, Jerrard-Dunne P, Sitzer M, et al. Rates and determinants of site-specific progression of carotid artery intimamedia thickness: the carotid atherosclerosis progression study. Stroke 2004; 35: 2150-4.
49. Barter PJ, Caulfield M, Eriksson M, et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med 2007; 357: 2109-22.
50. Bots ML, Palmer MK, Dogan S, et al. METEOR Study Group. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of treatment: the METEOR study. J Intern Med 2009; 265(6): 698-707.
51. Ridker PM, Danielson E, Fonesca FAH, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195-207.
52. Meaney A, Ceballos G, Asbun J, et al. The VYtorin on Carotid intima-media thickness and overall rigidity (VYCTOR) study. J Clin Pharmacol 2009; 49: 838-47.
53. Kumar SS, Lahey KA, Day A, LaHaye SA. Comparison of the efficacy of administering a combination of ezetimibe plus fenofibrate versus atorvastatin monotherapy in the treatment of dyslipidemia. Lipids Health Dis 2009; 8: 56.
54. Lewis SJ, Fox KM, Bullano MF, Grandy S. SHIELD Study Group. Knowledge of heart disease risk among SHIELD respondents with dyslipidemia. Circ Cardiovasc Qual Outcomes 2009; 2(3): 207-12.
55. Grover SA, Lowensteyn I, Joseph L, et al. Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial. Arch Intern Med 2007; 167(21): 2296-303.