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Возможности достижения целевых уровней липидов с помощью комбинированной терапии статинами и эзетимибом
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Shaposhnik I.I., Genkel V.V. Achieving target lipid levels with statin and ezetimibe combination therapy. Consilium Medicum. 2019; 21 (5): 38–42. DOI: 10.26442/20751753.2019.5.190380
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Ключевые слова: эзетимиб, Отрио, статины, холестерин липопротеинов низкой плотности, комбинированная терапия.
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Key words: ezetimibe, Otrio, statins, low-density lipoprotein cholesterol, combination therapy.
[Ezhov M.V., Blizniuk S.A., Alekseeva I.A., Vygodin V.A. Rasprostranennost' giperkholesterinemii i primeneniia statinov v ambulatornoi praktike v Rossiiskoi Federatsii. Issledovanie Aisberg – diagnostirovanie patsientov s giperkholesterinemiei v usloviiakh ambulatornoi praktiki na rannem etape s tsel'iu uluchsheniia serdechno-sosudistogo prognoza. Ateroskleroz i dislipidemii. 2017; 4 (29): 5–17 (in Russian).]
2. Мешков А.Н., Ершова А.И., Деев А.Д. и др. 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; 16 (4): 62–7.
[Meshkov A.N., Ershova A.I., Deev A.D. et al. 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; 16 (4): 62–7 (in Russian).]
3. Концевая А.В., Баланова Ю.А., Имаева А.Э. и др. Экономический ущерб от гиперхолестеринемии на популяционном уровне в Российской Федерации. Рациональная фармакотерапия в кардиологии. 2018; 14 (3): 393–401.
[Kontsevaia A.V., Balanova Iu.A., Imaeva A.E. et al. Ekonomicheskii ushcherb ot giperkholesterinemii na populiatsionnom urovne v Rossiiskoi Federatsii. Ratsional'naia farmakoterapiia v kardiologii. 2018; 14 (3): 393–401 (in Russian).]
4. Kotseva K, De Backer G, De Bacquer D et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol 2019. DOI: 10.1177/2047487318825350
5. Takase H, Dohi Y, Okado T et al. Effects of ezetimibe on visceral fat in the metabolic syndrome: a randomised controlled study. Eur J Clin Invest 2012; 42 (12): 1287–94. DOI: 10.1111/eci.12000
6. Koh KK, Oh PC, Sakuma I et al. Vascular and metabolic effects of ezetimibe combined with simvastatin in patients with hypercholesterolemia. Int J Cardiol 2015; 199: 126–31. DOI: 10.1016/j.ijcard.2015.07.016.
7. Ohbu-Murayama K, Adachi H, Hirai Y et al. Ezetimibe combined with standard diet and exercise therapy improves insulin resistance and atherosclerotic markers in patients with metabolic syndrome. J Diabetes Investig 2015; 6 (3): 325–33. DOI: 10.1111/jdi.12298
8. Wu H, Shang H, Wu J. Effect of ezetimibe on glycemic control: a systematic review and meta-analysis of randomized controlled trials. Endocrine 2018; 60 (2): 229–39. DOI: 10.1007/s12020-018-1541-4
9. Nakade Y, Murotani K, Inoue T, Kobayashi Y et al. Ezetimibe for the treatment of non-alcoholic fatty liver disease: A meta-analysis. Hepatol Res 2017; 47 (13): 1417–28. DOI: 10.1111/hepr.12887
10. Kalogirou M, Tsimihodimos V, Elisaf M. Pleiotropic effects of ezetimibe: do they really exist? Eur J Pharmacol 2010; 633 (1–3): 62–70. DOI: 10.1016/j.ejphar.2010.02.003
11. Hong N, Lee YH, Tsujita K et al. Comparison of the Effects of Ezetimibe-Statin Combination Therapy on Major Adverse Cardiovascular Events in Patients with and without Diabetes: A Meta-Analysis. Endocrinol Metab (Seoul) 2018; 33 (2): 219–27. DOI: 10.3803/EnM.2018.33.2.219
12. Mach F, Ray KK, Wiklund O et al. Adverse effects of statin therapy: perception vs. the evidence – focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract. Eur Heart J 2018; 39 (27): 2526–39. DOI: 10.1093/eurheartj/ehy182
13. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37 (39): 2999–58. DOI: 10.1093/eurheartj/ehw272
14. 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. et al. 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).]
15. Grundy SM, Stone NJ, Bailey AL et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation 2018. DOI: 10.1161/CIR.0000000000000625
16. Silverman MG, Ference BA, Im K et al. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA 2016; 316 (12): 1289–197. DOI: 10.1001/jama.2016.13985
17. Leibowitz M, Karpati T, Cohen-Stavi CJ et al. Association Between Achieved Low-Density Lipoprotein Levels and Major Adverse Cardiac Events in Patients With Stable Ischemic Heart Disease Taking Statin Treatment. JAMA Intern Med 2016; 176 (8): 1105-13. DOI: 10.1001/jamainternmed.2016.2751
18. Lee JH, Ko YG, Shin DH et al. Attainment of low-density lipoprotein cholesterol goal after endovascular treatment is associated with reduced cardiovascular events in patients with peripheral arterial disease. J Vasc Surg 2016; 63 (3): 756–63. DOI: 10.1016/j.jvs.2015.09.059
19. Cannon CP, Blazing MA, Giugliano RP et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015; 372: 2387–97. DOI: 10.1056/NEJMoa1410489
20. Giugliano RP, Pedersen TR, Park JG et al. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet 2017; 390 (10106): 1962–71. DOI: 10.1016/S0140-6736(17)32290-0
21. Cholesterol Treatment Trialists' Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. Lancet 2019; 393 (10170): 407–15. DOI: 10.1016/S0140-6736(18)31942-1
22. Ray KK, Bach RG, Cannon CP et al. Benefits of achieving the NCEP optional LDL-C goal among elderly patients with ACS. Eur Heart J 2006; 27 (19): 2310–6. DOI: 10.1093/eurheartj/ehl180
23. Сусеков А.В., Кобалава Ж.Д., Гуревич В.С. и др. Возможности клинического применения препарата эзетимиба Отрио (АО «АКРИХИН», Россия) у пациентов высокого и очень высокого сердечно-сосудистого риска, не достигших целевых значений показателей липидного обмена. Заключение Совета экспертов. Кардиология. 2019; 59 (5S): 47–57.
[Susekov A.V., Kobalava Zh.D., Gurevich V.S. et al. Vozmozhnosti klinicheskogo primeneniia preparata ezetimiba Otrio (AO "AKRIKhIN', Rossiia) u patsientov vysokogo i ochen' vysokogo serdechno-sosudistogo riska, ne dostigshikh tselevykh znachenii pokazatelei lipidnogo obmena. Zakliuchenie Soveta ekspertov. Kardiologiia. 2019; 59 (5S): 47–57. (in Russian).]
24. Kashani A, Sallam T, Bheemreddy S et al. Review of side-effect profile of combination ezetimibe and statin therapy in randomized clinical trials. Am J Cardiol 2008; 101 (11): 1606–13. DOI: 10.1016/j.amjcard.2008.01.041
25. Luo L, Yuan X, Huang W et al. Safety of coadministration of ezetimibe and statins in patients with hypercholesterolaemia: a meta‐analysis. Intern Med J 2015; 45 (5): 546–57. DOI: 10.1111/imj.12706
26. Davies GM, Vyas A, Baxter CA. Economic evaluation of ezetimibe treatment in combination with statin therapy in the United States. J Med Eco 2017; 20 (7): 723–31. DOI: 10.1080/13696998.2017.1320559
27. Suh DC, Griggs SK, Henderson ER et al. Comparative effectiveness of lipid-lowering treatments to reduce cardiovascular disease. Expert Rev Pharmacoecon Outcomes Res 2018; 18 (1): 51–69. DOI: 10.1080/14737167.2018.1407246
28. Ballantyne CM, Weiss R, Moccetti T et al. Efficacy and Safety of Rosuvastatin 40 mg Alone or in Combination with Ezetimibe in Patients at High Risk of Cardiovascular Disease. (results from the Explorer Study). Am J Cardiol 2007; 99: 673–80. DOI: 10.1016/j.amjcard.2006.10.022
29. Gryskiewicz KA, Coleman CI, Gillespie EL et al. Cost-Effectiveness Analysis of Combination Statin/Ezetimibe Therapy for the Treatment of Elevated Low-Density Lipoprotein Cholesterol. Hospital Pharmacy 2005; 40 (8): 687–92. DOI: 10.1177/001857870504000808
30. Wu NQ, Guo YL, Zhu CG et al. Comparison of statin plus ezetimibe with double-dose statin on lipid profiles and inflammation markers. Lipids Health Dis 2018; 17 (1): 265. DOI: 10.1186/s12944-018-0909-z
31. Foody JM, Toth PP, Tomassini JE et al. Changes in LDL-C levels and goal attainment associated with addition of ezetimibe to simvastatin, atorvastatin, or rosuvastatin compared with titrating statin monotherapy. Vasc Health Risk Manag 2013; 9: 719–27. DOI: 10.2147/VHRM.S49840
32. Ambegaonkar BM, Tipping D, Polis AB et al. Achieving goal lipid levels with ezetimibe plus statin add-on or switch therapy compared with doubling the statin dose. A pooled analysis. Atherosclerosis 2014; 237 (2): 829–37. DOI: 10.1016/j.atherosclerosis.2014.10.105
33. Lorenzi M, Ambegaonkar B, Baxter CA et al. Ezetimibe in high-risk, previously treated statin patients: a systematic review and network meta-analysis of lipid efficacy. Clin Res Cardiol 2019; 108 (5): 487–509. DOI: 10.1007/s00392-018-1379-z
34. Landmesser U, Chapman MJ, Farnier M et al. European Society of Cardiology/European Atherosclerosis Society Task Force consensus statement on proprotein convertase subtilisin/kexin type 9 inhibitors: practical guidance for use in patients at very high cardiovascular risk. Eur Heart J 2017; 38 (29): 2245–55. DOI: 10.1093/eurheartj/ehw480
35. Lloyd-Jones DM, Morris PB, Ballantyne CM et al. 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol 2017; 70 (14): 1785–822. DOI: 10.1016/j.jacc.2017.07.745
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1. Ezhov M.V., Blizniuk S.A., Alekseeva I.A., Vygodin V.A. Rasprostranennost' giperkholesterinemii i primeneniia statinov v ambulatornoi praktike v Rossiiskoi Federatsii. Issledovanie Aisberg – diagnostirovanie patsientov s giperkholesterinemiei v usloviiakh ambulatornoi praktiki na rannem etape s tsel'iu uluchsheniia serdechno-sosudistogo prognoza. Ateroskleroz i dislipidemii. 2017; 4 (29): 5–17 (in Russian).
2.Meshkov A.N., Ershova A.I., Deev A.D. et al. 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; 16 (4): 62–7 (in Russian).
3. Kontsevaia A.V., Balanova Iu.A., Imaeva A.E. et al. Ekonomicheskii ushcherb ot giperkholesterinemii na populiatsionnom urovne v Rossiiskoi Federatsii. Ratsional'naia farmakoterapiia v kardiologii. 2018; 14 (3): 393–401 (in Russian).
4. Kotseva K, De Backer G, De Bacquer D et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol 2019. DOI: 10.1177/2047487318825350
5. Takase H, Dohi Y, Okado T et al. Effects of ezetimibe on visceral fat in the metabolic syndrome: a randomised controlled study. Eur J Clin Invest 2012; 42 (12): 1287–94. DOI: 10.1111/eci.12000
6. Koh KK, Oh PC, Sakuma I et al. Vascular and metabolic effects of ezetimibe combined with simvastatin in patients with hypercholesterolemia. Int J Cardiol 2015; 199: 126–31. DOI: 10.1016/j.ijcard.2015.07.016.
7. Ohbu-Murayama K, Adachi H, Hirai Y et al. Ezetimibe combined with standard diet and exercise therapy improves insulin resistance and atherosclerotic markers in patients with metabolic syndrome. J Diabetes Investig 2015; 6 (3): 325–33. DOI: 10.1111/jdi.12298
8. Wu H, Shang H, Wu J. Effect of ezetimibe on glycemic control: a systematic review and meta-analysis of randomized controlled trials. Endocrine 2018; 60 (2): 229–39. DOI: 10.1007/s12020-018-1541-4
9. Nakade Y, Murotani K, Inoue T, Kobayashi Y et al. Ezetimibe for the treatment of non-alcoholic fatty liver disease: A meta-analysis. Hepatol Res 2017; 47 (13): 1417–28. DOI: 10.1111/hepr.12887
10. Kalogirou M, Tsimihodimos V, Elisaf M. Pleiotropic effects of ezetimibe: do they really exist? Eur J Pharmacol 2010; 633 (1–3): 62–70. DOI: 10.1016/j.ejphar.2010.02.003
11. Hong N, Lee YH, Tsujita K et al. Comparison of the Effects of Ezetimibe-Statin Combination Therapy on Major Adverse Cardiovascular Events in Patients with and without Diabetes: A Meta-Analysis. Endocrinol Metab (Seoul) 2018; 33 (2): 219–27. DOI: 10.3803/EnM.2018.33.2.219
12. Mach F, Ray KK, Wiklund O et al. Adverse effects of statin therapy: perception vs. the evidence – focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract. Eur Heart J 2018; 39 (27): 2526–39. DOI: 10.1093/eurheartj/ehy182
13. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37 (39): 2999–58. DOI: 10.1093/eurheartj/ehw272
14. Ezhov M.V., Sergienko I.V., Aronov D.M. et al. 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).
15. Grundy SM, Stone NJ, Bailey AL et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation 2018. DOI: 10.1161/CIR.0000000000000625
16. Silverman MG, Ference BA, Im K et al. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA 2016; 316 (12): 1289–197. DOI: 10.1001/jama.2016.13985
17. Leibowitz M, Karpati T, Cohen-Stavi CJ et al. Association Between Achieved Low-Density Lipoprotein Levels and Major Adverse Cardiac Events in Patients With Stable Ischemic Heart Disease Taking Statin Treatment. JAMA Intern Med 2016; 176 (8): 1105-13. DOI: 10.1001/jamainternmed.2016.2751
18. Lee JH, Ko YG, Shin DH et al. Attainment of low-density lipoprotein cholesterol goal after endovascular treatment is associated with reduced cardiovascular events in patients with peripheral arterial disease. J Vasc Surg 2016; 63 (3): 756–63. DOI: 10.1016/j.jvs.2015.09.059
19. Cannon CP, Blazing MA, Giugliano RP et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015; 372: 2387–97. DOI: 10.1056/NEJMoa1410489
20. Giugliano RP, Pedersen TR, Park JG et al. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet 2017; 390 (10106): 1962–71. DOI: 10.1016/S0140-6736(17)32290-0
21. Cholesterol Treatment Trialists' Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. Lancet 2019; 393 (10170): 407–15. DOI: 10.1016/S0140-6736(18)31942-1
22. Ray KK, Bach RG, Cannon CP et al. Benefits of achieving the NCEP optional LDL-C goal among elderly patients with ACS. Eur Heart J 2006; 27 (19): 2310–6. DOI: 10.1093/eurheartj/ehl180
23. Susekov A.V., Kobalava Zh.D., Gurevich V.S. et al. Vozmozhnosti klinicheskogo primeneniia preparata ezetimiba Otrio (AO "AKRIKhIN', Rossiia) u patsientov vysokogo i ochen' vysokogo serdechno-sosudistogo riska, ne dostigshikh tselevykh znachenii pokazatelei lipidnogo obmena. Zakliuchenie Soveta ekspertov. Kardiologiia. 2019; 59 (5S): 47–57. (in Russian).
24. Kashani A, Sallam T, Bheemreddy S et al. Review of side-effect profile of combination ezetimibe and statin therapy in randomized clinical trials. Am J Cardiol 2008; 101 (11): 1606–13. DOI: 10.1016/j.amjcard.2008.01.041
25. Luo L, Yuan X, Huang W et al. Safety of coadministration of ezetimibe and statins in patients with hypercholesterolaemia: a meta‐analysis. Intern Med J 2015; 45 (5): 546–57. DOI: 10.1111/imj.12706
26. Davies GM, Vyas A, Baxter CA. Economic evaluation of ezetimibe treatment in combination with statin therapy in the United States. J Med Eco 2017; 20 (7): 723–31. DOI: 10.1080/13696998.2017.1320559
27. Suh DC, Griggs SK, Henderson ER et al. Comparative effectiveness of lipid-lowering treatments to reduce cardiovascular disease. Expert Rev Pharmacoecon Outcomes Res 2018; 18 (1): 51–69. DOI: 10.1080/14737167.2018.1407246
28. Ballantyne CM, Weiss R, Moccetti T et al. Efficacy and Safety of Rosuvastatin 40 mg Alone or in Combination with Ezetimibe in Patients at High Risk of Cardiovascular Disease. (results from the Explorer Study). Am J Cardiol 2007; 99: 673–80. DOI: 10.1016/j.amjcard.2006.10.022
29. Gryskiewicz KA, Coleman CI, Gillespie EL et al. Cost-Effectiveness Analysis of Combination Statin/Ezetimibe Therapy for the Treatment of Elevated Low-Density Lipoprotein Cholesterol. Hospital Pharmacy 2005; 40 (8): 687–92. DOI: 10.1177/001857870504000808
30. Wu NQ, Guo YL, Zhu CG et al. Comparison of statin plus ezetimibe with double-dose statin on lipid profiles and inflammation markers. Lipids Health Dis 2018; 17 (1): 265. DOI: 10.1186/s12944-018-0909-z
31. Foody JM, Toth PP, Tomassini JE et al. Changes in LDL-C levels and goal attainment associated with addition of ezetimibe to simvastatin, atorvastatin, or rosuvastatin compared with titrating statin monotherapy. Vasc Health Risk Manag 2013; 9: 719–27. DOI: 10.2147/VHRM.S49840
32. Ambegaonkar BM, Tipping D, Polis AB et al. Achieving goal lipid levels with ezetimibe plus statin add-on or switch therapy compared with doubling the statin dose. A pooled analysis. Atherosclerosis 2014; 237 (2): 829–37. DOI: 10.1016/j.atherosclerosis.2014.10.105
33. Lorenzi M, Ambegaonkar B, Baxter CA et al. Ezetimibe in high-risk, previously treated statin patients: a systematic review and network meta-analysis of lipid efficacy. Clin Res Cardiol 2019; 108 (5): 487–509. DOI: 10.1007/s00392-018-1379-z
34. Landmesser U, Chapman MJ, Farnier M et al. European Society of Cardiology/European Atherosclerosis Society Task Force consensus statement on proprotein convertase subtilisin/kexin type 9 inhibitors: practical guidance for use in patients at very high cardiovascular risk. Eur Heart J 2017; 38 (29): 2245–55. DOI: 10.1093/eurheartj/ehw480
35. Lloyd-Jones DM, Morris PB, Ballantyne CM et al. 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol 2017; 70 (14): 1785–822. DOI: 10.1016/j.jacc.2017.07.745
ФГБОУ ВО «Южно-Уральский государственный медицинский университет» Минздрава России, Челябинск, Россия
*shaposhnik@yandex.ru
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South-Ural State Medical University, Chelyabinsk, Russia
*shaposhnik@yandex.ru