Высокоинтенсивная терапия: обоснование, показания и вопросы безопасности. Перспективы розувастатина в клинической практике

1. Townsend N, Wilson L, Bhatnagar P et al. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J 2016; 37: 3232–45. DOI: 10.1093/eurheartj/ehw334
2. Piepoli MF, Hoes AW, Agewall S et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2016; 37: 2315–81.
3. World Health Organisation. WHO Global Health Repository. Cardiovascular diseases, deaths per 100 000. 2016. Data by country. http://apps.who.int/gho/data/node.main. A865CARDIOVASCULAR?lang=en
4. Keys A, Menotti A, Aravanis C et al. Seven Countries Study. The seven countries study: 2,289 deaths in 15 years. Prev Med 1984; 13 (2): 141–54.
5. Метельская В.А., Шальнова С.А., Деев А.Д. и др. Анализ распространенности показателей, характеризующих атерогенность спектра липопротеинов, у жителей Российской Федерации (по данным исследования ЭССЕ-РФ). Профилактическая медицина. 2016; 19 (1): 15–23. / Metel'skaia V.A., Shal'nova S.A., Deev A.D. i dr. Analiz rasprostranennosti pokazatelei, kharakterizuiushchikh aterogennost' spektra lipoproteinov, u zhitelei Rossiiskoi Federatsii (po dannym issledovaniia ESSE-RF). Profilakticheskaia meditsina. 2016; 19 (1): 15–23. [in Russian]
6. Мешков А.Н., Ершова А.И., Деев А.Д. и др. от имени участников исследования ЭССЕ-РФ. Распределение показателей липидного спектра у мужчин и женщин трудоспособного возраста в Российской Федерации: результаты исследования ЭССЕ-РФ за 2012–2014 гг. Кардиоваскулярная терапия и профилактика. 2017; 4: 62–7. / Meshkov A.N., Ershova A.I., Deev A.D. i dr. ot imeni uchastnikov issledovaniia ESSE-RF. Raspredelenie pokazatelei lipidnogo spektra u muzhchin i zhenshchin trudosposobnogo vozrasta v Rossiiskoi Federatsii: rezul'taty issledovaniia ESSE-RF za 2012–2014 gg. Kardiovaskuliarnaia terapiia i profilaktika. 2017; 4: 62–7. [in Russian]
7. Ference BA, Ginsberg HN, Graham I et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J 2017. DOI: 10.1093/eurheartj/ehx144
8. Jacobson TA, Ito MK, Maki KC et al. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 1 – Full Report. J Clin Lipidol 2015; 9: 129–69.
9. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J 2016; 37: 2999–3058. DOI: 10.1093/eurheartj/ ehw272
10. Ежов М.В., Сергиенко И.В., Аронов Д.М. и др. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Российские рекомендации. VI пересмотр. Атеросклероз и дислипидемии. 2017; 3 (28): 5–22. / Ezhov M.V., Sergienko I.V., Aronov D.M. i dr. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Rossiiskie rekomendatsii. VI peresmotr. Ateroskleroz i dislipidemii. 2017; 3 (28): 5–22. [in Russian]
11. Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, Emberson J et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010; 376: 1670–81.
12. Collins R, Reith C, Emberson J et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; 388: 2532–61.
13. Karlson BW, Wiklund O, Palmer MK et al. Variability of low-density lipoprotein cholesterol response with different doses of atorvastatin, rosuvastatin, and simvastatin: results from VOYAGER. Eur Heart J – Cardiovasc Pharmacother 2016; 2: 212–7.
14. Pitt B, Loscalzo J, Monyak J et al. Comparison of Lipid-Modifying Efficacy of Rosuvastatin Versus Atorvastatin in Patients With Acute Coronary Syndrome (from the LUNAR Study). Am J Cardiol 2012; 109: 1239–46.
15. Schwartz GG, Olsson AG, Ezekowitz MD et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 2001; 285: 1711–8.
16. Cannon CP, Braunwald E, McCabe CH et al. Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes. Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis in Myocardial Infarction 22. N Engl J Med 2004; 350: 1495–504.
17. Wiviott SD, Cannon CP, Morrow DA et al. Can low-density lipoprotein be too low? The safety and efficacy of achieving very low low-density lipoprotein with intensive statin therapy: a PROVE IT-TIMI 22 substudy. J Am Coll Cardiol 2005; 46: 1411–6.
18. Boekholdt SM, Hovingh GK, Mora S et al. Very Low Levels of Atherogenic Lipoproteins and the Risk for Cardiovascular Events A Meta-Analysis of Statin Trials. JACC 2014; 5: 485–94.
19. Sabatine MS, Giugliano RP, Keech AC et al. FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376: 1713–22. DOI: 10.1056/NEJMoa1615664
20. Ridker PM, Danielson E, Fonseca EAH et al. for the JUPITER Study Group. Rosuvastatin to prevent vascular events in men women with elevated C-Reactive Protein. N Engl J Med 2008; 359: 2195–207.
21. Ridker PM, Mora S, Rose L, on Behalf of the JUPITER Trial Study Group. Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid-lowering agents. Eur Heart J 2016; 37: 1373–9. DOI: 10.1093/eurheartj/ehw046
22. Hsia J, MacFadyen JG, Monyak J, Ridker PM. Cardiovascular event reduction and adverse events among subjects attaining low-density lipoprotein cholesterol <50 mg/dl with rosuvastatin The JUPITER Trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). J Am Coll Cardiol 2011; 57: 1666–75. DOI: 10.1016/j.jacc.2010. 09.082
23. Nicholls SJ, Ballantyne CM, Barter PJ et al. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med 2011; 365: 2078–87.
24. Nissen SE, Tuzcu EM, Schoenhagen P et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis. A randomized controlled trial. JAMA 2004; 291: 1071–80.
25. Kataoka Y, Hammadah M, Puri R et al. Plaque microstructures in patients with coronary artery disease who achieved very low low-density lipoprotein cholesterol levels. Atherosclerosis 2015; 242: 490–5.
26. Falk E, Nakano M, Bentzon JF et al. Update on acute coronary syndromes: the pathologists' view. Eur Heart J 2013; 34: 719–28.
27. Virmani R, Kolodgie FD, Burke AP et al. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol 2000; 20: 1262–75.
28. Puri R, Nissen SE, Libby P et al. C-reactive protein, but not low-density lipoprotein cholesterol levels, associate with coronary atheroma regression and cardiovascular events after maximally intensive statin therapy. Circulation 2013; 128: 2395–403.
29. Crouse III JR, Raichlen JS, Evans GW et al. Effects of Rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical аtherosclerosis. The METEOR trial. JAMA 2007; 297: 1344–53.
30. Jones PH, Hunninghake DB, Ferdinand KC et al., for the Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin (STELLAR) Study Group. Effects of Rosuvastatin Versus Atorvastatin, Simvastatin, and Pravastatin on Non–High-Density Lipoprotein Cholesterol, Apolipoproteins, and Lipid Ratios in Patients with Hypercholesterolemia: Additional Results from the STELLAR Trial. Clin Ther 2004; 26: 1388–99.
31. Nicholls SJ, Puri R, Anderson T et al. Effect of evolocumab on progression of coronary disease in statin-treated patients. The GLAGOV randomized clinical trial. JAMA 2016; 316: 2373–84.
32. Ference BA, Yoo W, Alesh I et al. Effect of long-term exposure to lower low-density lipoprotein cholesterol beginning early in life on the risk of coronary heart disease: a Mendelian randomization analysis. J Am Coll Cardiol 2012; 60: 2631–9.
33. Vallejo-Vaz AJ, Robertson M, Catapano AL et al. LDL-Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men with Primary Elevations of LDL-Cholesterol Levels of 190 mg/dL or Above: Analyses from the WOSCOPS 5-year Randomised Trial and 20-year Observational Follow-Up. Circulation 2017; 136: 1876–91.
34. Ference B. A naturally randomized trial comparing the effect of long-term exposure to LDL-C, lower SBP, or both on the risk of cardiovascular disease. European Society of Cardiology Congress 2016; August 29, 2016; Rome, Italy. Abstract 3163.
35. Armitage J. The safety of statins in clinical practice. Lancet 2007; 370: 1781–90. DOI: 10.1016/S0140-6736(07)60716-8
36. McGuinnes B, O’Hare J, Craig D et al. Cochrane review on 'Statins for the treatment of dementia'. Int J Geriatr Psychiatry 2013; 28 (2): 119–26.
37. McKinney JS, Kostis WJ. Statin therapy and the risk of intracerebral hemorrhage: a metaanalysis of 31 randomized controlled trials. Stroke 2012; 43 (8): 2149–56.
38. White CM. A reviews of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002; 42: 963–70.
39. Cheng WM. Rosuvastatin in the management of hyperlipidemia. Clin Ther 2004; 26: 1368–87.

________________________________________________

1. Townsend N, Wilson L, Bhatnagar P et al. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J 2016; 37: 3232–45. DOI: 10.1093/eurheartj/ehw334
2. Piepoli MF, Hoes AW, Agewall S et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2016; 37: 2315–81.
3. World Health Organisation. WHO Global Health Repository. Cardiovascular diseases, deaths per 100 000. 2016. Data by country. http://apps.who.int/gho/data/node.main. A865CARDIOVASCULAR?lang=en
4. Keys A, Menotti A, Aravanis C et al. Seven Countries Study. The seven countries study: 2,289 deaths in 15 years. Prev Med 1984; 13 (2): 141–54.
5. Metel'skaia V.A., Shal'nova S.A., Deev A.D. i dr. Analiz rasprostranennosti pokazatelei, kharakterizuiushchikh aterogennost' spektra lipoproteinov, u zhitelei Rossiiskoi Federatsii (po dannym issledovaniia ESSE-RF). Profilakticheskaia meditsina. 2016; 19 (1): 15–23. [in Russian]
6. Meshkov A.N., Ershova A.I., Deev A.D. i dr. ot imeni uchastnikov issledovaniia ESSE-RF. Raspredelenie pokazatelei lipidnogo spektra u muzhchin i zhenshchin trudosposobnogo vozrasta v Rossiiskoi Federatsii: rezul'taty issledovaniia ESSE-RF za 2012–2014 gg. Kardiovaskuliarnaia terapiia i profilaktika. 2017; 4: 62–7. [in Russian]
7. Ference BA, Ginsberg HN, Graham I et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J 2017. DOI: 10.1093/eurheartj/ehx144
8. Jacobson TA, Ito MK, Maki KC et al. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 1 – Full Report. J Clin Lipidol 2015; 9: 129–69.
9. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J 2016; 37: 2999–3058. DOI: 10.1093/eurheartj/ ehw272
10. Ezhov M.V., Sergienko I.V., Aronov D.M. i dr. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Rossiiskie rekomendatsii. VI peresmotr. Ateroskleroz i dislipidemii. 2017; 3 (28): 5–22. [in Russian]
11. Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, Emberson J et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010; 376: 1670–81.
12. Collins R, Reith C, Emberson J et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; 388: 2532–61.
13. Karlson BW, Wiklund O, Palmer MK et al. Variability of low-density lipoprotein cholesterol response with different doses of atorvastatin, rosuvastatin, and simvastatin: results from VOYAGER. Eur Heart J – Cardiovasc Pharmacother 2016; 2: 212–7.
14. Pitt B, Loscalzo J, Monyak J et al. Comparison of Lipid-Modifying Efficacy of Rosuvastatin Versus Atorvastatin in Patients With Acute Coronary Syndrome (from the LUNAR Study). Am J Cardiol 2012; 109: 1239–46.
15. Schwartz GG, Olsson AG, Ezekowitz MD et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 2001; 285: 1711–8.
16. Cannon CP, Braunwald E, McCabe CH et al. Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes. Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis in Myocardial Infarction 22. N Engl J Med 2004; 350: 1495–504.
17. Wiviott SD, Cannon CP, Morrow DA et al. Can low-density lipoprotein be too low? The safety and efficacy of achieving very low low-density lipoprotein with intensive statin therapy: a PROVE IT-TIMI 22 substudy. J Am Coll Cardiol 2005; 46: 1411–6.
18. Boekholdt SM, Hovingh GK, Mora S et al. Very Low Levels of Atherogenic Lipoproteins and the Risk for Cardiovascular Events A Meta-Analysis of Statin Trials. JACC 2014; 5: 485–94.
19. Sabatine MS, Giugliano RP, Keech AC et al. FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376: 1713–22. DOI: 10.1056/NEJMoa1615664
20. Ridker PM, Danielson E, Fonseca EAH et al. for the JUPITER Study Group. Rosuvastatin to prevent vascular events in men women with elevated C-Reactive Protein. N Engl J Med 2008; 359: 2195–207.
21. Ridker PM, Mora S, Rose L, on Behalf of the JUPITER Trial Study Group. Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid-lowering agents. Eur Heart J 2016; 37: 1373–9. DOI: 10.1093/eurheartj/ehw046
22. Hsia J, MacFadyen JG, Monyak J, Ridker PM. Cardiovascular event reduction and adverse events among subjects attaining low-density lipoprotein cholesterol <50 mg/dl with rosuvastatin The JUPITER Trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). J Am Coll Cardiol 2011; 57: 1666–75. DOI: 10.1016/j.jacc.2010. 09.082
23. Nicholls SJ, Ballantyne CM, Barter PJ et al. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med 2011; 365: 2078–87.
24. Nissen SE, Tuzcu EM, Schoenhagen P et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis. A randomized controlled trial. JAMA 2004; 291: 1071–80.
25. Kataoka Y, Hammadah M, Puri R et al. Plaque microstructures in patients with coronary artery disease who achieved very low low-density lipoprotein cholesterol levels. Atherosclerosis 2015; 242: 490–5.
26. Falk E, Nakano M, Bentzon JF et al. Update on acute coronary syndromes: the pathologists' view. Eur Heart J 2013; 34: 719–28.
27. Virmani R, Kolodgie FD, Burke AP et al. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol 2000; 20: 1262–75.
28. Puri R, Nissen SE, Libby P et al. C-reactive protein, but not low-density lipoprotein cholesterol levels, associate with coronary atheroma regression and cardiovascular events after maximally intensive statin therapy. Circulation 2013; 128: 2395–403.
29. Crouse III JR, Raichlen JS, Evans GW et al. Effects of Rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical аtherosclerosis. The METEOR trial. JAMA 2007; 297: 1344–53.
30. Jones PH, Hunninghake DB, Ferdinand KC et al., for the Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin (STELLAR) Study Group. Effects of Rosuvastatin Versus Atorvastatin, Simvastatin, and Pravastatin on Non–High-Density Lipoprotein Cholesterol, Apolipoproteins, and Lipid Ratios in Patients with Hypercholesterolemia: Additional Results from the STELLAR Trial. Clin Ther 2004; 26: 1388–99.
31. Nicholls SJ, Puri R, Anderson T et al. Effect of evolocumab on progression of coronary disease in statin-treated patients. The GLAGOV randomized clinical trial. JAMA 2016; 316: 2373–84.
32. Ference BA, Yoo W, Alesh I et al. Effect of long-term exposure to lower low-density lipoprotein cholesterol beginning early in life on the risk of coronary heart disease: a Mendelian randomization analysis. J Am Coll Cardiol 2012; 60: 2631–9.
33. Vallejo-Vaz AJ, Robertson M, Catapano AL et al. LDL-Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men with Primary Elevations of LDL-Cholesterol Levels of 190 mg/dL or Above: Analyses from the WOSCOPS 5-year Randomised Trial and 20-year Observational Follow-Up. Circulation 2017; 136: 1876–91.
34. Ference B. A naturally randomized trial comparing the effect of long-term exposure to LDL-C, lower SBP, or both on the risk of cardiovascular disease. European Society of Cardiology Congress 2016; August 29, 2016; Rome, Italy. Abstract 3163.
35. Armitage J. The safety of statins in clinical practice. Lancet 2007; 370: 1781–90. DOI: 10.1016/S0140-6736(07)60716-8
36. McGuinnes B, O’Hare J, Craig D et al. Cochrane review on 'Statins for the treatment of dementia'. Int J Geriatr Psychiatry 2013; 28 (2): 119–26.
37. McKinney JS, Kostis WJ. Statin therapy and the risk of intracerebral hemorrhage: a metaanalysis of 31 randomized controlled trials. Stroke 2012; 43 (8): 2149–56.
38. White CM. A reviews of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002; 42: 963–70.
39. Cheng WM. Rosuvastatin in the management of hyperlipidemia. Clin Ther 2004; 26: 1368–87.

М.Г.Бубнова

ФГБУ «Национальный медицинский исследовательский центр профилактической медицины» Минздрава России. 101990, Россия, Москва, Петроверигский пер., д. 10, стр. 3
mbubnova@gnicpm.ru

________________________________________________

M.G.Bubnova

National Medical Research Center for Preventive Medicine of the Ministry of Health of the Russian Federation. 101990, Russian Federation, Moscow, Petroverigskii per., d. 10, str. 3
mbubnova@gnicpm.ru