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Компания Санофи представила инновационный препарат для снижения уровня холестерина
Компания Санофи представила инновационный препарат для снижения уровня холестерина
Компания Санофи представила инновационный препарат для снижения уровня холестерина. Consilium Medicum. 2017; 19 (12): 74–75. DOI: 10.26442/2075-1753_19.12.74-75
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Аннотация
Санкт-Петербург, 10 ноября 2017 г. – компания Санофи объявила о запуске в России нового лекарственного препарата для снижения уровня холестерина (ХС) Пралуэнт (алирокумаб) на Национальном конгрессе кардиологов, который прошел с 24 по 27 октября в Санкт-Петербурге. Лекарственный препарат показан для снижения концентрации ХС липопротеинов низкой плотности (ЛПНП) у взрослых пациентов с первичной гиперхолестеринемией (ГХС) или смешанной дислипидемией [1]. Алирокумаб является биологическим препаратом, представителем нового класса ингибиторов пропротеиновой конвертазы субтилизин-кексин типа 9 – PCSK9. Пралуэнт был зарегистрирован в России 16 января 2017 г. и с июня 2017 г. доступен для российских пациентов.
Полный текст
Список литературы
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8. Диагностика и коррекция нарушений липидного обмена с целью профилактики атеросклероза. Российские рекомендации, VI пересмотр. Атеросклероз и дислипидемия. 2017; 3: 5–22. / Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki ateroskleroza. Rossiiskie rekomendatsii, VI peresmotr. Ateroskleroz i dislipidemiia. 2017; 3: 5–22. [in Russian]
9. Оганов Р.Г., Кухарчук В.В. и др. Сохраняющиеся нарушения показателей липидного спектра у пациентов с дислипидемией, получающих статины, в реальной клинической практике в Российской Федерации (российская часть исследования DYSIS). Кардиоваск. терапия и профилактика. 2012; 4. / Oganov R.G., Kukharchuk V.V. i dr. Sokhraniaiushchiesia narusheniia pokazatelei lipidnogo spektra u patsientov s dislipidemiei, poluchaiushchikh statiny, v real'noi klinicheskoi praktike v Rossiiskoi Federatsii (rossiiskaia chast' issledovaniia DYSIS). Kardiovask. terapiia i profilaktika. 2012; 4. [in Russian]
10. Roth EM. Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications. Future Cardiol 2016; 12 (2): 115–28.
11. https://grls.rosminzdrav.ru/CIPermitionReg.aspx Параметры поиска «алирокумаб». / https://grls.rosminzdrav.ru/CIPermitionReg.aspx Parametry poiska «alirokumab». [in Russian]
12. Robinson JG, Farnier M, Krempf M et al, for the ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015; 372 (Suppl.): 1489–99; 1–75.
13. Jones PH et al. Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials. Am J Cardiol 2016; 118: 1805e1811.
14. Schwartz G et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial. Am Heart J 2014; 168: 682–9.e1.
15. Müller-Wieland D et al. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol 2017; 16: 70.
16. Cariou B et al. Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY
DM-INSULIN trial. Diabetes Metab 2017 Mar 24. pii: S1262-3636(17)30008-3. DOI: 10.1016/j.diabet.2017.01.004 [Epub ahead of print]
17. Kastelein J et al. Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia. Coronary Artery Disease 2017; 28: 190–7.
2. Chazova I.E., Oshchepkova E.V., Zhernakova Iu.V. Klinicheskie rekomendatsii. Diagnostika i lechenie arterial'noi gipertonii. Kardiol. vestn. 2015; 1: 3–30. [in Russian]
3. Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe 2014: epidemiological update. Eur Heart J 2014; 35 (42): 2950–9. DOI: 10.1093/eurheartj/ehu299. Epub 2014 Aug 19.
4. Zdravookhranenie v Rossii. 2015. Stat. sb. Rosstat. M., 2015. [in Russian]
5. Ference BA et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, anclinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J 2017.
6. Jacobson TA, Ito MK, Maki KC et al. National Lipid Association recommendations for patient-centered management of dyslipidemia:Part 1-executive summary. J Clin Lipidol 2014; 8: 473–88.
7. Perk J, De backer G, Gohlke H et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J 2012; 33 (13): 1635–701.
8. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki ateroskleroza. Rossiiskie rekomendatsii, VI peresmotr. Ateroskleroz i dislipidemiia. 2017; 3: 5–22. [in Russian]
9. Oganov R.G., Kukharchuk V.V. i dr. Sokhraniaiushchiesia narusheniia pokazatelei lipidnogo spektra u patsientov s dislipidemiei, poluchaiushchikh statiny, v real'noi klinicheskoi praktike v Rossiiskoi Federatsii (rossiiskaia chast' issledovaniia DYSIS). Kardiovask. terapiia i profilaktika. 2012; 4. [in Russian]
10. Roth EM. Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications. Future Cardiol 2016; 12 (2): 115–28.
11. https://grls.rosminzdrav.ru/CIPermitionReg.aspx Parametry poiska «alirokumab». [in Russian]
12. Robinson JG, Farnier M, Krempf M et al, for the ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015; 372 (Suppl.): 1489–99; 1–75.
13. Jones PH et al. Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials. Am J Cardiol 2016; 118: 1805e1811.
14. Schwartz G et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial. Am Heart J 2014; 168: 682–9.e1.
15. Müller-Wieland D et al. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol 2017; 16: 70.
16. Cariou B et al. Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY
DM-INSULIN trial. Diabetes Metab 2017 Mar 24. pii: S1262-3636(17)30008-3. DOI: 10.1016/j.diabet.2017.01.004 [Epub ahead of print]
17. Kastelein J et al. Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia. Coronary Artery Disease 2017; 28: 190–7.
2. Чазова И.Е., Ощепкова Е.В., Жернакова Ю.В. Клинические рекомендации. Диагностика и лечение артериальной гипертонии. Кардиол. вестн. 2015; 1: 3–30. / Chazova I.E., Oshchepkova E.V., Zhernakova Iu.V. Klinicheskie rekomendatsii. Diagnostika i lechenie arterial'noi gipertonii. Kardiol. vestn. 2015; 1: 3–30. [in Russian]
3. Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe 2014: epidemiological update. Eur Heart J 2014; 35 (42): 2950–9. DOI: 10.1093/eurheartj/ehu299. Epub 2014 Aug 19.
4. Здравоохранение в России. 2015. Стат. сб. Росстат. М., 2015. / Zdravookhranenie v Rossii. 2015. Stat. sb. Rosstat. M., 2015. [in Russian]
5. Ference BA et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, anclinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J 2017.
6. Jacobson TA, Ito MK, Maki KC et al. National Lipid Association recommendations for patient-centered management of dyslipidemia:Part 1-executive summary. J Clin Lipidol 2014; 8: 473–88.
7. Perk J, De backer G, Gohlke H et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J 2012; 33 (13): 1635–701.
8. Диагностика и коррекция нарушений липидного обмена с целью профилактики атеросклероза. Российские рекомендации, VI пересмотр. Атеросклероз и дислипидемия. 2017; 3: 5–22. / Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki ateroskleroza. Rossiiskie rekomendatsii, VI peresmotr. Ateroskleroz i dislipidemiia. 2017; 3: 5–22. [in Russian]
9. Оганов Р.Г., Кухарчук В.В. и др. Сохраняющиеся нарушения показателей липидного спектра у пациентов с дислипидемией, получающих статины, в реальной клинической практике в Российской Федерации (российская часть исследования DYSIS). Кардиоваск. терапия и профилактика. 2012; 4. / Oganov R.G., Kukharchuk V.V. i dr. Sokhraniaiushchiesia narusheniia pokazatelei lipidnogo spektra u patsientov s dislipidemiei, poluchaiushchikh statiny, v real'noi klinicheskoi praktike v Rossiiskoi Federatsii (rossiiskaia chast' issledovaniia DYSIS). Kardiovask. terapiia i profilaktika. 2012; 4. [in Russian]
10. Roth EM. Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications. Future Cardiol 2016; 12 (2): 115–28.
11. https://grls.rosminzdrav.ru/CIPermitionReg.aspx Параметры поиска «алирокумаб». / https://grls.rosminzdrav.ru/CIPermitionReg.aspx Parametry poiska «alirokumab». [in Russian]
12. Robinson JG, Farnier M, Krempf M et al, for the ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015; 372 (Suppl.): 1489–99; 1–75.
13. Jones PH et al. Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials. Am J Cardiol 2016; 118: 1805e1811.
14. Schwartz G et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial. Am Heart J 2014; 168: 682–9.e1.
15. Müller-Wieland D et al. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol 2017; 16: 70.
16. Cariou B et al. Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY
DM-INSULIN trial. Diabetes Metab 2017 Mar 24. pii: S1262-3636(17)30008-3. DOI: 10.1016/j.diabet.2017.01.004 [Epub ahead of print]
17. Kastelein J et al. Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia. Coronary Artery Disease 2017; 28: 190–7.
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2. Chazova I.E., Oshchepkova E.V., Zhernakova Iu.V. Klinicheskie rekomendatsii. Diagnostika i lechenie arterial'noi gipertonii. Kardiol. vestn. 2015; 1: 3–30. [in Russian]
3. Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe 2014: epidemiological update. Eur Heart J 2014; 35 (42): 2950–9. DOI: 10.1093/eurheartj/ehu299. Epub 2014 Aug 19.
4. Zdravookhranenie v Rossii. 2015. Stat. sb. Rosstat. M., 2015. [in Russian]
5. Ference BA et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, anclinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J 2017.
6. Jacobson TA, Ito MK, Maki KC et al. National Lipid Association recommendations for patient-centered management of dyslipidemia:Part 1-executive summary. J Clin Lipidol 2014; 8: 473–88.
7. Perk J, De backer G, Gohlke H et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J 2012; 33 (13): 1635–701.
8. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki ateroskleroza. Rossiiskie rekomendatsii, VI peresmotr. Ateroskleroz i dislipidemiia. 2017; 3: 5–22. [in Russian]
9. Oganov R.G., Kukharchuk V.V. i dr. Sokhraniaiushchiesia narusheniia pokazatelei lipidnogo spektra u patsientov s dislipidemiei, poluchaiushchikh statiny, v real'noi klinicheskoi praktike v Rossiiskoi Federatsii (rossiiskaia chast' issledovaniia DYSIS). Kardiovask. terapiia i profilaktika. 2012; 4. [in Russian]
10. Roth EM. Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications. Future Cardiol 2016; 12 (2): 115–28.
11. https://grls.rosminzdrav.ru/CIPermitionReg.aspx Parametry poiska «alirokumab». [in Russian]
12. Robinson JG, Farnier M, Krempf M et al, for the ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015; 372 (Suppl.): 1489–99; 1–75.
13. Jones PH et al. Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials. Am J Cardiol 2016; 118: 1805e1811.
14. Schwartz G et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial. Am Heart J 2014; 168: 682–9.e1.
15. Müller-Wieland D et al. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol 2017; 16: 70.
16. Cariou B et al. Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY
DM-INSULIN trial. Diabetes Metab 2017 Mar 24. pii: S1262-3636(17)30008-3. DOI: 10.1016/j.diabet.2017.01.004 [Epub ahead of print]
17. Kastelein J et al. Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia. Coronary Artery Disease 2017; 28: 190–7.
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