В статье обсуждаются современные принципы гиполипидемической терапии и подходы к ее назначению с позиции величины сердечно-сосудистого риска. Дана характеристика групп пациентов с разной величиной сердечно-сосудистого риска (от низкого до высокого) в первичной профилактике, обозначены целевые уровни холестерина липопротеидов низкой плотности, которых следует достигать при назначении современной гиполипидемической терапии. Представлены клинические эффекты статинов в первичной профилактике. Обсуждены клинические результаты двух крупных исследований с применением розувастатина, изменивших подходы к назначению статинов в первичной профилактике. Даны результаты анализов многолетнего наблюдения за пациентами в первичной профилактике после завершения рандомизированных клинических исследований. Обозначены подходы к приему статинов в распространении новой коронавирусной инфекции.
The article discusses the modern principles of lipid-lowering therapy and approaches to its administration in terms of levels of cardiovascular risk. The characteristics of groups of patients with different levels of cardiovascular risk (from low to high) in primary prevention are given. The article defines the target levels of low- density lipoprotein cholesterol, which should be achieved with the modern lipid-lowering therapy. The clinical effects of statins in primary prevention are presented. The clinical results of two large studies of rosuvastatin that have changed the approach to statin prescribing in primary prevention are discussed. The article presents the results of the analysis of long-term follow-up of patients in the primary prevention after the completion of randomized clinical studies. Approaches to the use of statins for novel coronavirus infection are considered.
1. Roth GA, Johnson C, Abajobir A, et al. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015. J Am Coll of Cardiol. 2017;70(1):1-25. DOI:10.1016/j.jacc.2017.04.052
2. Концевая А.В., Баланова Ю.А., Имаева А.Э., и др. Экономический ущерб от гиперхолестеринемии на популяционном уровне в Российской Федерации. Рацион. фармакотерапия в rардиологии. 2018;14(3):393-401 [Kontsevaya AV, Balanova YA, Imaeva AE. et al. Economic Burden of Hypercholesterolemia in the Russian Federation. Rational Pharmacotherapy in Cardiology. 2018;14(3):393-401 (in Russian)]. DOI:10.20996/1819-6446-2018-14-3-393-401
3. National Institute for Health and Care Excellence. NICE Public Health Guidance 25. June 2010. Available at: https://www.nice.org.uk/guidance/ph25. Accessed: 07.05.2021
4. Аронов Д.М., Бубнова М.Г., Драпкина О.М. Немедикаментозная терапия больных с сердечно-сосудистыми заболеваниями в программах кардиореабилитации. Профилактическая медицина. 2020;23(6):57-64 [Aronov DM, Bubnova MG, Drapkina OM. Non-pharmacological therapy of patients with cardiovascular diseases in cardiac rehabilitation programs. The Russian Journal of Preventive Medicine. 2020;23(6):57-64 (in Russian)]. DOI:10.17116/profmed20202306257
5. 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. DOI:10.1093/eurheartj/ehw106
6. 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 [Metelskaya VA Shalnova CA, Deev AD, et al. Analysis of atherogenic dyslipidemias prevalence among population of Russian Federation (Results of the ESSE-RF study). The Russian Journal of Preventive Medicine. 2016;19(1):15-23 (in Russian)]. DOI:10.17116/profmed201619115-23
7. Kotseva K, De Backer G, De Bacquer D, et al. Primary prevention efforts are poorly developed in people at high cardiovascular risk: A report from the European Society of Cardiology EURObservational Research Programme EUROASPIRE V survey in 16 European countries. Eur J Prev Cardiol. 2020; 2047487320908698. DOI:10.1177/2047487320908698
8. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;290:140-205. DOI:10.1016/j.atherosclerosis.2019.08.014
9. Кухарчук В.В., Ежов М.В., Сергиенко И.В., и др. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза Российские рекомендации, VII пересмотр. Атеросклероз и дислипидемии. 2020;38(1):7-42 [Kukharchuk VV, Ezhov MV, Sergienko IV, et al. Diagnosis and correction of dyslipidemia for the prevention and treatment of atherosclerosis. Russian Guidelines, VII. Journal of Atherosclerosis and dyslipidaemias. 2020;38(1):7-42
(in Russian)]. DOI:10.34687/2219-8202.JAD.2020.01.0002
10. Shuster H. The GALAXY Program: an update on studies investigating efficacy and tolerability of rosuvastatin for reducing cardiovascular risk. Expert Rev Cardiovasc Ther. 2007;5(2):177-93.
11. McKenney JM, Jones PH, Adamczyk MA, et al. Comparison of efficacy of rosuvastatin verus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin. 2003;19:689-98. DOI:10.1185/030079903125002405
12. 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.
DOI:10.1093/ehjcvp/pvw006
13. Blasetto JW, Stein EA, Brown WV, et al. Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups Am J Cardiol. 2003;91(5A):3C-10C. DOI:10.1016/S0002-9149(03)00003-1
14. Ridker P, Danielson E, Fonsesa FHA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.
N Engl J Med. 2008;359:2195-207. DOI:10.1056/NEJMoa0807646
15. Ridker P, Danielson E, Fonsesa FHA, et al. Reduction in C-reactive and LDL cholesterol and cardiovascular events rate after initiation of rosuvastatin: a prospective study of the JUPITER. Lancet. 2009:373:1175-82.0
DOI:10.1016/S0140-6736(09)60447-5
16. Ridker PM, Mora S, Rose L, et al. 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
17. Kunutsor SK, Seidu S, Khunti K. Statins and secondary prevention of venous thromboembolism: pooled analysis of published observational cohort studies. Eur Heart J. 2017;38:1608-12. DOI:10.1093/eurheartj/ehx107
18. Glynn RJ, Danielson E, Fonseca FA, et al. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009;360:1851-61. DOI:10.1056/NEJMoa0900241
19. Yusuf S, Bosch J, Dagenais G, et al. for the HOPE-3 Investigators. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016;26;374(21):2021-31. DOI:10.1056/NEJMoa1600176
20. Ridker PM, Pradhan A, Jean G, et al. Cardiovascular Benefits and Diabetes Risks of Statin Therapy in Primary Prevention. Lancet. 2012;380(9841):565-71. DOI:10.1016/S0140-6736(12)61190-8
21. Wang Y-C, Hsieh T-C, Chou C-L, et al. Risks of Adverse Events Following Coprescription of Statins and Calcium Channel Blockers: A Nationwide Population-Based Study Medicine (Baltimore). 2016;95(2):e2487. DOI:10.1097/MD.0000000000002487
22. Mills EJ, Rachlis B, Wu P, et al. Primary Prevention of Cardiovascular Mortality and Events With Statin Treatments. J Am Coll Cardiol. 2008;52:1769-81. DOI:10.1016/j.jacc.2008.08.039
23. Brugts JJ, Yetgin T, Hoeks SE, et al. The benefits of statin in people withot established cardiovascular risk factors: meta-analysis of randomized controlled trials. BMJ. 2009;338:b2376. DOI:10.1136/bmj.b2376
24. Yebyo HG, Aschmann HE, Kaufmann M, Puhan MA. Comparative effectiveness and safety of statins as a class and of specific statins for primary prevention of cardiovascular disease: A systematic review, meta-analysis, and network meta-analysis of randomized trials with 94,283 participants. Am Heart J. 2019;210:18-28. DOI:10.1016/j.ahj.2018.12.007
25. Ford I, Murray H, McCowan C, Packard CJ. Long-Term Safety and Efficacy of Lowering Low-Density Lipoprotein Cholesterol With Statin Therapy 20-Year Follow-Up of West of Scotland Coronary Prevention Study. Circulation. 2016;133:1073-80. DOI:10.1161/CIRCULATIONAHA.115.019014
26. 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;38:2459-472. DOI:10.1093/eurheartj/ehx144
27. Временные методические рекомендации. Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19) версия 11 (07.05.2021) Министерства здравоохранения Российской Федерации. Режим доступа: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/054/588/original/Временные_МР_COVID.... Ссылка активна на 07.05.2021 [Temporary guidelines for Prevention, diagnosis and treatment of new coronavirus infection (COVID-19) version 11 (07.05.2021) of the Ministry of health of the Russian Federation. Available at: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/054/588/original/Временные_МР_COVID... Accessed: 07.05.2021 (in Russian)].
28. Iqbal Z, Ho JH, Adam S, et al. Managing hyperlipidaemia in patients with COVID-19 and during its pandemic: An expert panel position statement from HEART UK. Atherosclerosis. 2020;313:126-36. DOI:10.1016/j.atherosclerosis.2020.09.008
29. Fan Z, Chen L, Li J, et al. Clinical features of COVID-19-related liver damage. Clin Gastroenterol Hepatol. 2020;18:1561-6. DOI:10.1101/2020.02.26.200226971
________________________________________________
1. Roth GA, Johnson C, Abajobir A, et al. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015. J Am Coll of Cardiol. 2017;70(1):1-25. DOI:10.1016/j.jacc.2017.04.052
2. Kontsevaya AV, Balanova YA, Imaeva AE. et al. Economic Burden of Hypercholesterolemia in the Russian Federation. Rational Pharmacotherapy in Cardiology. 2018;14(3):393-401 (in Russian) DOI:10.20996/1819-6446-2018-14-3-393-401
3. National Institute for Health and Care Excellence. NICE Public Health Guidance 25. June 2010. Available at: https://www.nice.org.uk/guidance/ph25. Accessed: 07.05.2021
4. Aronov DM, Bubnova MG, Drapkina OM. Non-pharmacological therapy of patients with cardiovascular diseases in cardiac rehabilitation programs. The Russian Journal of Preventive Medicine. 2020;23(6):57-64 (in Russian) DOI:10.17116/profmed20202306257
5. 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. DOI:10.1093/eurheartj/ehw106
6. Metelskaya VA Shalnova CA, Deev AD, et al. Analysis of atherogenic dyslipidemias prevalence among population of Russian Federation (Results of the ESSE-RF study). The Russian Journal of Preventive Medicine. 2016;19(1):15-23 (in Russian) DOI:10.17116/profmed201619115-23
7. Kotseva K, De Backer G, De Bacquer D, et al. Primary prevention efforts are poorly developed in people at high cardiovascular risk: A report from the European Society of Cardiology EURObservational Research Programme EUROASPIRE V survey in 16 European countries. Eur J Prev Cardiol. 2020; 2047487320908698. DOI:10.1177/2047487320908698
8. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;290:140-205. DOI:10.1016/j.atherosclerosis.2019.08.014
9. Kukharchuk VV, Ezhov MV, Sergienko IV, et al. Diagnosis and correction of dyslipidemia for the prevention and treatment of atherosclerosis. Russian Guidelines, VII. Journal of Atherosclerosis and dyslipidaemias. 2020;38(1):7-42
(in Russian) DOI:10.34687/2219-8202.JAD.2020.01.0002
10. Shuster H. The GALAXY Program: an update on studies investigating efficacy and tolerability of rosuvastatin for reducing cardiovascular risk. Expert Rev Cardiovasc Ther. 2007;5(2):177-93.
11. McKenney JM, Jones PH, Adamczyk MA, et al. Comparison of efficacy of rosuvastatin verus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin. 2003;19:689-98. DOI:10.1185/030079903125002405
12. 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.
DOI:10.1093/ehjcvp/pvw006
13. Blasetto JW, Stein EA, Brown WV, et al. Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups Am J Cardiol. 2003;91(5A):3C-10C. DOI:10.1016/S0002-9149(03)00003-1
14. Ridker P, Danielson E, Fonsesa FHA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195-207. DOI:10.1056/NEJMoa0807646
15. Ridker P, Danielson E, Fonsesa FHA, et al. Reduction in C-reactive and LDL cholesterol and cardiovascular events rate after initiation of rosuvastatin: a prospective study of the JUPITER. Lancet. 2009:373:1175-82.0
DOI:10.1016/S0140-6736(09)60447-5
16. Ridker PM, Mora S, Rose L, et al. 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
17. Kunutsor SK, Seidu S, Khunti K. Statins and secondary prevention of venous thromboembolism: pooled analysis of published observational cohort studies. Eur Heart J. 2017;38:1608-12. DOI:10.1093/eurheartj/ehx107
18. Glynn RJ, Danielson E, Fonseca FA, et al. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009;360:1851-61. DOI:10.1056/NEJMoa0900241
19. Yusuf S, Bosch J, Dagenais G, et al. for the HOPE-3 Investigators. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016;26;374(21):2021-31. DOI:10.1056/NEJMoa1600176
20. Ridker PM, Pradhan A, Jean G, et al. Cardiovascular Benefits and Diabetes Risks of Statin Therapy in Primary Prevention. Lancet. 2012;380(9841):565-71. DOI:10.1016/S0140-6736(12)61190-8
21. Wang Y-C, Hsieh T-C, Chou C-L, et al. Risks of Adverse Events Following Coprescription of Statins and Calcium Channel Blockers: A Nationwide Population-Based Study Medicine (Baltimore). 2016;95(2):e2487. DOI:10.1097/MD.0000000000002487
22. Mills EJ, Rachlis B, Wu P, et al. Primary Prevention of Cardiovascular Mortality and Events With Statin Treatments. J Am Coll Cardiol. 2008;52:1769-81. DOI:10.1016/j.jacc.2008.08.039
23. Brugts JJ, Yetgin T, Hoeks SE, et al. The benefits of statin in people withot established cardiovascular risk factors: meta-analysis of randomized controlled trials. BMJ. 2009;338:b2376. DOI:10.1136/bmj.b2376
24. Yebyo HG, Aschmann HE, Kaufmann M, Puhan MA. Comparative effectiveness and safety of statins as a class and of specific statins for primary prevention of cardiovascular disease: A systematic review, meta-analysis, and network meta-analysis of randomized trials with 94,283 participants. Am Heart J. 2019;210:18-28. DOI:10.1016/j.ahj.2018.12.007
25. Ford I, Murray H, McCowan C, Packard CJ. Long-Term Safety and Efficacy of Lowering Low-Density Lipoprotein Cholesterol With Statin Therapy 20-Year Follow-Up of West of Scotland Coronary Prevention Study. Circulation. 2016;133:1073-80. DOI:10.1161/CIRCULATIONAHA.115.019014
26. 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;38:2459-472. DOI:10.1093/eurheartj/ehx144
27. Temporary guidelines for Prevention, diagnosis and treatment of new coronavirus infection (COVID-19) version 11 (07.05.2021) of the Ministry of health of the Russian Federation. Available at: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/054/588/original/Временные_МР_COVID... Accessed: 07.05.2021 (in Russian)
28. Iqbal Z, Ho JH, Adam S, et al. Managing hyperlipidaemia in patients with COVID-19 and during its pandemic: An expert panel position statement from HEART UK. Atherosclerosis. 2020;313:126-36. DOI:10.1016/j.atherosclerosis.2020.09.008
29. Fan Z, Chen L, Li J, et al. Clinical features of COVID-19-related liver damage. Clin Gastroenterol Hepatol. 2020;18:1561-6. DOI:10.1101/2020.02.26.200226971
Авторы
М.Г. Бубнова*1, М.Ю. Ильченко2, П.А. Лебедев3
1 ФГБУ «Национальный медицинский исследовательский центр терапии и профилактической медицины» Минздрава России, Москва, Россия;
2 ФКУЗ «Медико-санитарная часть МВД России по Самарской области», Самара, Россия;
3 ФГБОУ ВО «Самарский государственный медицинский университет» Минздрава России, Самара, Россия
*mbubnova@gnicpm.ru
________________________________________________
Marina G. Bubnova*1, Marianna Yu. Ilchenko2, Petr A. Lebedev3
1 National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia;
2 Medical and Sanitary Unit of the Ministry of Internal Affairs of Russia for the Samara Region, Samara, Russia;
3 Samara State Medical University, Samara, Russia
*mbubnova@gnicpm.ru