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Место розувастатина в первичной и вторичной профилактике сердечно-сосудистых заболеваний
Место розувастатина в первичной и вторичной профилактике сердечно-сосудистых заболеваний
Ялымов А.А., Шехян Г.Г., Щикота А.М., Задионченко В.С. Место розувастатина в первичной и вторичной профилактике сердечно-сосудистых заболеваний. Consilium Medicum. 2016; 18 (5): 70–76. DOI: 10.26442/2075-1753_2016.5.70-76
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Аннотация
Атеросклероз и его основные осложнения продолжают лидировать в структуре заболеваемости и смертности западных стран и России. Повышение уровня общего холестерина за счет липопротеидов низкой плотности, по данным ряда эпидемиологических исследований, является одним из основных факторов риска развития и прогрессирования атеросклероза. Клинические исследования позволили обозначить целевые уровни липидов и липопротеидов в крови, которые ассоциированы с минимальным риском развития смертельных и несмертельных сердечно-сосудистых осложнений у пациента. Только достижение целевых липидных значений на фоне медикаментозных и немедикаментозных вмешательств является тем индикатором, по которому оценивается эффективность проводимых профилактических мероприятий против атеросклероза. Изучение эффектов розувастатина проведено в программе GALAXY, в которую вошли более 170 тыс. больных. За прошедшие 10 лет завершен ряд исследований розувастатина по изучению гиполипидемической эффективности и влиянию на маркеры воспаления (исследования ARIES, COMETS, DISCOVERY, EXPLORER, MERCURI I–II, ORBITAL, PULSAR, STELLAR и др.), воздействию розувастатина на регрессию атеросклероза по суррогатным точкам (METEOR, ORION, ASTEROID) и влиянию лечения этим статином на сердечно-сосудистую и общую смертность в специальных популяциях (CORONA, AVRORA, JUPITER). Появление качественных генериков розувастатина (и в частности препарата Тевастор®, фармацевтическая компания «Тева») позволило сделать современную гиполипидемическую терапию более доступной для пациентов. Результаты сравнительных клинических исследований продемонстрировали полную биоэквивалентность препарата Тевастор® и оригинального розувастатина. Тевастор® является эффективным препаратом, препятствующим развитию тяжелых ишемических исходов (сосудистая смерть, инсульт, инфаркт миокарда) и прогрессированию сердечной недостаточности. Благоприятное влияние препарата Тевастор® проявляется в уменьшении частоты эпизодов ишемии и их продолжительности, повышении антиаритмического эффекта проводимого лечения, улучшении показатели центральной гемодинамики, замедлении процессов ремоделирования левого желудочка. Этот статин хорошо переносится, его профиль безопасности сравним с таковыми для других доступных статинов. Таким образом, Тевастор® можно рассматривать как средство, улучшающее прогноз и течение ряда заболеваний сердечно-сосудистой системы.
Ключевые слова: дислипидемии, атерогенные липопротеиды, атеросклероз, ингибиторы редуктазы гидроксиметил-глютарового кофермента А, статины, розувастатин, плейотропные эффекты.
Ключевые слова: дислипидемии, атерогенные липопротеиды, атеросклероз, ингибиторы редуктазы гидроксиметил-глютарового кофермента А, статины, розувастатин, плейотропные эффекты.
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Atherosclerosis and the main complications of atherosclerosis continue to dominate in the structure of morbidity and mortality in Western countries and Russia. Total cholesterol level increase due to low-density lipoprotein, according to the results of epidemiological studies is one of the major risk factors for the development and progression of atherosclerosis. Clinical studies helped to determine the target blood lipid and lipoprotein levels, which were associated with minimal risk of fatal and nonfatal cardiovascular events. Only the achievement of target lipid levels associated with drug application and nondrug acting is the predictor to estimate the efficacy of activity in prevention of atherosclerosis. The GALAXY programme was held to investigate rosuvastatin effect and enrolled over 170 000 patients. Over the past 10 years, the series of studies of rosuvastatin application concerning the hypolipidemic efficacy and the effects on the markers of inflammation (such as ARIES, COMETS, DISCOVERY, EXPLORER, MERCURI I-II, ORBITAL, PULSAR, STELLAR, etc.), of rosuvastatin impact on regression of atherosclerosis according to surrogate endpoints (METEOR, ORION, ASTEROID) and of rosuvastatin effects on cardiovascular and total mortality in special populations (CORONA, AVRORA, JUPITER) were completed. The appearance of qualitative generic rosuvastatin (and in particular the drug Tevastor®, Teva Pharmaceuticals) has made the modern hypolipidemic therapy more accessible to patients. The results of comparative clinical studies have demonstrated that Tevastor® is totally bioequivalent to the original rosuvastatin. Tevastor® is an effective drug preventing bad ischemic outcomes (cardiovascular death, stroke, myocardial infarction) and the progression of heart failure. The favorable effect of Tevastor® is the decrease in the frequency of ischemic episodes and their duration, the increase of the antiarrhythmic treatment effect, the improvement of central hemodynamics parameters and Tevastor® is slowing down the process of left ventricular remodeling. Tevastor® is well tolerated «statin» and has a comparable safety profile to other available statins. Thus, Tevastor® can be considered as a drug improving the prognosis and the course of several cardiovascular diseases.
Key words: dyslipidemia, atherogenic lipoproteins, atherosclerosis, the HMG-CoA reductase inhibitors, statins, rosuvastatin, pleiotropic effects.
Key words: dyslipidemia, atherogenic lipoproteins, atherosclerosis, the HMG-CoA reductase inhibitors, statins, rosuvastatin, pleiotropic effects.
Полный текст
Список литературы
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2. Zadionchenko V.S., Shekhian G.G., Shakhrai N.B. i dr. Vliianie rozuvastatina na lipidnyi obmen, mikrotsirkuliatsiiu i pokazateli tsentral'noi gemodinamiki u bol'nykh s ostrym koronarnym sindromom. Consilium Medicum. 2011; 13 (5): 85–9. [in Russian]
3. Rekomendatsii Komiteta ekspertov Vserossiiskogo nauchnogo obshchestva kardiologov. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza (IV peresmotr). Kardiovask. terapiia i profilaktika. 2009; 8 (6). [in Russian]
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7. Betteridge DJ, Gibson JM, Sager PT. Comparison of effectiveness of rosuvastatin versus atorvastatin on the achievement of combined C-reactive protein (<2 mg/l) and low-density lipoprotein cholesterol (<70 mg/dl) targets in patients with type 2 diabetes mellitus (from the ANDROMEDA study). Am J Cardiol 2007; 100: 1245–8.
8. Binbrek AS, Elis A, Al-Zaibag M et al. Rosuvastatin versus atorvastatin in achieving lipid goals in patients at high risk for cardiovascular disease in clinical practice: a randomized, open-label, parallel-group, multicenter study (DISCOVERY Alpha Study). Curr Ther Res Clin Exp 2006; 67: 21–43.
9. Clearfield M, Kallend D, Palmer M. Efficacy and safety of rosuvastatin 10 mg versus atorvastatin 20 mg: results of the PULSAR study. Atheroscler (Suppl.) 2005; 6: 104.
10. Danchin N, Chadarevian R, Gayet J-L et al. Compared with atorvastatin at a dose of 10 mg per day rosuvastatin was more effective to reach an LDL goal of <1.00 g/l in high cardiovascular risk patients (ARIANE study). Ann Cardiol Angiol (Paris) 2007; 56: 82–7.
11. Faergeman O, Hill L, Windler E et al. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Results from the ECLIPSE Study. Cardiol 2008; 111: 219–28.
12. Jones PH, Davidson MH, Stein EA et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR trial). Am J Cardiol 2003; 92: 152–60.
13. Lablanche JM, Danchin N, Farnier M et al. Effects of rosuvastatin and atorvastatin on the apolipoprotein B/apolipoprotein A-1 ratio in patients with an acute coronary syndrome: The CENTAURUS trial design. Arch Cardiovasc. Dis 2008; 101: 399–406.
14. Ridker PM, MacFadyen J, Cressman M et al. Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein: a secondary analysis from the JUPITER (Justification for the Use of Statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) trial. J Am Coll Cardiol 2010; 55: 1266–73.
15. Schuster H, Barter PJ, Stender S et al. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapy (MERCURY I) study. Am Heart J 2004; 147: 705–12.
16. Schuster 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.
17. Soeda T, Uemura S, Okayama S et al. Intensive Lipid-Lowering Therapy With Rosuvastatin Stabilizes Lipid-Rich Coronary Plaques (Evaluation Using Dual-Source Computed Tomography). Circ J 2011; 75: 2621–7.
18. Erbs S, Beck EB, Linke A et al. High-dose rosuvastatin in chronic heart failure promotes vasculogenesis, corrects endothelial function, and improves cardiac remodeling-results from a randomized, double-blind, and placebo-controlled study. Int J Cardiol 2011; 7, 146 (1): 56–63.
2. Задионченко В.С., Шехян Г.Г., Шахрай Н.Б. и др. Влияние розувастатина на липидный обмен, микроциркуляцию и показатели центральной гемодинамики у больных с острым коронарным синдромом. Consilium Medicum. 2011; 13 (5): 85–9. / Zadionchenko V.S., Shekhian G.G., Shakhrai N.B. i dr. Vliianie rozuvastatina na lipidnyi obmen, mikrotsirkuliatsiiu i pokazateli tsentral'noi gemodinamiki u bol'nykh s ostrym koronarnym sindromom. Consilium Medicum. 2011; 13 (5): 85–9. [in Russian]
3. Рекомендации Комитета экспертов Всероссийского научного общества кардиологов. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза (IV пересмотр). Кардиоваск. терапия и профилактика. 2009; 8 (6). / Rekomendatsii Komiteta ekspertov Vserossiiskogo nauchnogo obshchestva kardiologov. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza (IV peresmotr). Kardiovask. terapiia i profilaktika. 2009; 8 (6). [in Russian]
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5. Бойцов С.А., Сусеков А.В., Аронов Д.М. и др. Актуальные вопросы терапии статинами в клинической практике. Совещание совета экспертов. Атеросклероз и дислипидемии. 2011; 1: 65–6. / Boitsov S.A., Susekov A.V., Aronov D.M. i dr. Aktual'nye voprosy terapii statinami v klinicheskoi praktike. Soveshchanie soveta ekspertov. Ateroskleroz i dislipidemii. 2011; 1: 65–6. [in Russian]
6. Berne C, Siewert-Delle A; and URANUS study investigators. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc. Diabetol 2005; 4: 7.
7. Betteridge DJ, Gibson JM, Sager PT. Comparison of effectiveness of rosuvastatin versus atorvastatin on the achievement of combined C-reactive protein (<2 mg/l) and low-density lipoprotein cholesterol (<70 mg/dl) targets in patients with type 2 diabetes mellitus (from the ANDROMEDA study). Am J Cardiol 2007; 100: 1245–8.
8. Binbrek AS, Elis A, Al-Zaibag M et al. Rosuvastatin versus atorvastatin in achieving lipid goals in patients at high risk for cardiovascular disease in clinical practice: a randomized, open-label, parallel-group, multicenter study (DISCOVERY Alpha Study). Curr Ther Res Clin Exp 2006; 67: 21–43.
9. Clearfield M, Kallend D, Palmer M. Efficacy and safety of rosuvastatin 10 mg versus atorvastatin 20 mg: results of the PULSAR study. Atheroscler (Suppl.) 2005; 6: 104.
10. Danchin N, Chadarevian R, Gayet J-L et al. Compared with atorvastatin at a dose of 10 mg per day rosuvastatin was more effective to reach an LDL goal of <1.00 g/l in high cardiovascular risk patients (ARIANE study). Ann Cardiol Angiol (Paris) 2007; 56: 82–7.
11. Faergeman O, Hill L, Windler E et al. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Results from the ECLIPSE Study. Cardiol 2008; 111: 219–28.
12. Jones PH, Davidson MH, Stein EA et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR trial). Am J Cardiol 2003; 92: 152–60.
13. Lablanche JM, Danchin N, Farnier M et al. Effects of rosuvastatin and atorvastatin on the apolipoprotein B/apolipoprotein A-1 ratio in patients with an acute coronary syndrome: The CENTAURUS trial design. Arch Cardiovasc. Dis 2008; 101: 399–406.
14. Ridker PM, MacFadyen J, Cressman M et al. Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein: a secondary analysis from the JUPITER (Justification for the Use of Statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) trial. J Am Coll Cardiol 2010; 55: 1266–73.
15. Schuster H, Barter PJ, Stender S et al. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapy (MERCURY I) study. Am Heart J 2004; 147: 705–12.
16. Schuster 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.
17. Soeda T, Uemura S, Okayama S et al. Intensive Lipid-Lowering Therapy With Rosuvastatin Stabilizes Lipid-Rich Coronary Plaques (Evaluation Using Dual-Source Computed Tomography). Circ J 2011; 75: 2621–7.
18. Erbs S, Beck EB, Linke A et al. High-dose rosuvastatin in chronic heart failure promotes vasculogenesis, corrects endothelial function, and improves cardiac remodeling-results from a randomized, double-blind, and placebo-controlled study. Int J Cardiol 2011; 7, 146 (1): 56–63.
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2. Zadionchenko V.S., Shekhian G.G., Shakhrai N.B. i dr. Vliianie rozuvastatina na lipidnyi obmen, mikrotsirkuliatsiiu i pokazateli tsentral'noi gemodinamiki u bol'nykh s ostrym koronarnym sindromom. Consilium Medicum. 2011; 13 (5): 85–9. [in Russian]
3. Rekomendatsii Komiteta ekspertov Vserossiiskogo nauchnogo obshchestva kardiologov. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza (IV peresmotr). Kardiovask. terapiia i profilaktika. 2009; 8 (6). [in Russian]
4. Rekomendatsii Komiteta ekspertov Vserossiiskogo nauchnogo obshchestva kardiologov i Natsinal'nogo nauchnogo obshchestva «Kardiovaskuliarnaia profilaktika i reabilitatsiia». Kardiovaskuliarnaia profilaktika. Kardiovask. terapiia i profilaktika. 2011; 10 (6), Pril. 2. [in Russian]
5. Boitsov S.A., Susekov A.V., Aronov D.M. i dr. Aktual'nye voprosy terapii statinami v klinicheskoi praktike. Soveshchanie soveta ekspertov. Ateroskleroz i dislipidemii. 2011; 1: 65–6. [in Russian]
6. Berne C, Siewert-Delle A; and URANUS study investigators. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc. Diabetol 2005; 4: 7.
7. Betteridge DJ, Gibson JM, Sager PT. Comparison of effectiveness of rosuvastatin versus atorvastatin on the achievement of combined C-reactive protein (<2 mg/l) and low-density lipoprotein cholesterol (<70 mg/dl) targets in patients with type 2 diabetes mellitus (from the ANDROMEDA study). Am J Cardiol 2007; 100: 1245–8.
8. Binbrek AS, Elis A, Al-Zaibag M et al. Rosuvastatin versus atorvastatin in achieving lipid goals in patients at high risk for cardiovascular disease in clinical practice: a randomized, open-label, parallel-group, multicenter study (DISCOVERY Alpha Study). Curr Ther Res Clin Exp 2006; 67: 21–43.
9. Clearfield M, Kallend D, Palmer M. Efficacy and safety of rosuvastatin 10 mg versus atorvastatin 20 mg: results of the PULSAR study. Atheroscler (Suppl.) 2005; 6: 104.
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Авторы
А.А.Ялымов*, Г.Г.Шехян, А.М.Щикота, В.С.Задионченко
ГБОУ ВПО Московский государственный медико-стоматологический университет им. А.И.Евдокимова Минздрава России. 127473, Россия, Москва, ул. Делегатская, д. 20, стр. 1
*ayalymov@gmail.com
ГБОУ ВПО Московский государственный медико-стоматологический университет им. А.И.Евдокимова Минздрава России. 127473, Россия, Москва, ул. Делегатская, д. 20, стр. 1
*ayalymov@gmail.com
________________________________________________
A.A.Yalymov*, G.G.Shekhyan, A.M.Shchikota, V.S.Zadionchenko
A.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian Federation. 127473, Russian Federation, Moscow,ul. Delegatskaia, d. 20, str. 1
*ayalymov@gmail.com
A.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian Federation. 127473, Russian Federation, Moscow,ul. Delegatskaia, d. 20, str. 1
*ayalymov@gmail.com
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