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Динамика параметров липидного обмена при смене таргетной терапии гиперхолестеринемии после перенесенного острого коронарного синдрома
Динамика параметров липидного обмена при смене таргетной терапии гиперхолестеринемии после перенесенного острого коронарного синдрома
Некрасов А.А., Тимощенко Е.С., Ерофеева С.Г., Кузякина Е.С., Некрасова Т.А. Динамика параметров липидного обмена при смене таргетной терапии гиперхолестеринемии после перенесенного острого коронарного синдрома. Терапевтический архив. 2026;98(2):105–109. DOI: 10.26442/00403660.2026.02.203601
© ООО «КОНСИЛИУМ МЕДИКУМ», 2026 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2026 г.
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Аннотация
Цель. Оценить динамику липидного обмена при переходе с инклисирана на алирокумаб в ходе гиполипидемической терапии (ГЛТ) после острого коронарного синдрома (ОКС).
Материалы и методы. Наблюдали 26 больных, переживших ОКС, с холестерином липопротеидов низкой плотности (ХС ЛНП)≥4,0 ммоль/л во время госпитализации. Всем в течение 6 мес после ОКС назначен инклисиран. Каждый больной получил его как минимум 2 раза. У всех ожидали незапланированный переход с инклисирана на алирокумаб по логистическим причинам. Все пациенты дали согласие на участие в исследовании. Провели 8 визитов с оценкой ХС ЛНП: за 3 и 1 мес до окончания терапии инклисираном, в день первой инъекции и через 1, 2, 3, 4 и 5 мес от начала терапии алирокумабом.
Результаты. Уровни ХС ЛНП (Me [Q1; Q3]) в период действия инклисирана (визиты 1–3) составили 1,34 [0,55; 1,41], 1,44 [0,53; 2,00], 1,67 [1,08; 1,96] ммоль/л, на этапе лечения алирокумабом (визиты 4–8) – 1,10 [0,61; 1,55], 0,95 [0,69; 1,40], 1,01 [0,86; 1,55], 0,88 [0,71; 1,53], 0,87 [0,70; 1,22] ммоль/л (р=0,002). Первое введение алирокумаба на визите 3 было связано с наибольшим снижением ХС ЛНП за месяц (-34,1%; р=0,001).
Заключение. Смена инклисирана на алирокумаб у переживших ОКС больных вела к быстрому снижению ХС ЛНП без развития нежелательных явлений.
Ключевые слова: острый коронарный синдром, гиполипидемическая терапия, смена инклисирана на алирокумаб
Materials and methods. 26 patients survived ACS with low-density lipoprotein cholesterol (LDL-C)≥4.0 mmol/L during hospitalization were included. All patients were prescribed inclisiran within 6 months after ACS. Each patient received it at least twice. All patients were expected to undergo an unplanned switch from inclisiran to alirocumab due to logistical reasons. All patients gave consent to participate in the study. Eight visits were conducted to assess LDL-C levels: 3 and 1 month before the end of inclisiran therapy, on the day of the first alirocumab injection and 1, 2, 3, 4, and 5 months after the start of alirocumab therapy.
Results. LDL-C values (Me [Q1; Q3]) during the inclisiran treatment period (visits 1–3) were 1.34 [0.55; 1.41], 1.44 [0.53; 2.00], 1.67 [1.08; 1.96] mmol/l and during alirocumab treatment (visits 4–8) – 1.10 [0.61; 1.55], 0.95 [0.69; 1.40], 1.01 [0.86; 1.55], 0.88 [0.71; 1.53], 0.87 [0.70; 1.22] mmol/l (p=0.002). The first administration of alirocumab at visit 3 was associated with the greatest reduction in LDL-C over the month (-34.1%; p=0.001).
Conclusion. The switch from inclisiran to alirocumab in post-ACS patients resulted in a rapid LDL-C reduction without any adverse events.
Keywords: acute coronary syndrome, lipid-lowering therapy, switching from inclisiran to alirocumab
Материалы и методы. Наблюдали 26 больных, переживших ОКС, с холестерином липопротеидов низкой плотности (ХС ЛНП)≥4,0 ммоль/л во время госпитализации. Всем в течение 6 мес после ОКС назначен инклисиран. Каждый больной получил его как минимум 2 раза. У всех ожидали незапланированный переход с инклисирана на алирокумаб по логистическим причинам. Все пациенты дали согласие на участие в исследовании. Провели 8 визитов с оценкой ХС ЛНП: за 3 и 1 мес до окончания терапии инклисираном, в день первой инъекции и через 1, 2, 3, 4 и 5 мес от начала терапии алирокумабом.
Результаты. Уровни ХС ЛНП (Me [Q1; Q3]) в период действия инклисирана (визиты 1–3) составили 1,34 [0,55; 1,41], 1,44 [0,53; 2,00], 1,67 [1,08; 1,96] ммоль/л, на этапе лечения алирокумабом (визиты 4–8) – 1,10 [0,61; 1,55], 0,95 [0,69; 1,40], 1,01 [0,86; 1,55], 0,88 [0,71; 1,53], 0,87 [0,70; 1,22] ммоль/л (р=0,002). Первое введение алирокумаба на визите 3 было связано с наибольшим снижением ХС ЛНП за месяц (-34,1%; р=0,001).
Заключение. Смена инклисирана на алирокумаб у переживших ОКС больных вела к быстрому снижению ХС ЛНП без развития нежелательных явлений.
Ключевые слова: острый коронарный синдром, гиполипидемическая терапия, смена инклисирана на алирокумаб
________________________________________________
Materials and methods. 26 patients survived ACS with low-density lipoprotein cholesterol (LDL-C)≥4.0 mmol/L during hospitalization were included. All patients were prescribed inclisiran within 6 months after ACS. Each patient received it at least twice. All patients were expected to undergo an unplanned switch from inclisiran to alirocumab due to logistical reasons. All patients gave consent to participate in the study. Eight visits were conducted to assess LDL-C levels: 3 and 1 month before the end of inclisiran therapy, on the day of the first alirocumab injection and 1, 2, 3, 4, and 5 months after the start of alirocumab therapy.
Results. LDL-C values (Me [Q1; Q3]) during the inclisiran treatment period (visits 1–3) were 1.34 [0.55; 1.41], 1.44 [0.53; 2.00], 1.67 [1.08; 1.96] mmol/l and during alirocumab treatment (visits 4–8) – 1.10 [0.61; 1.55], 0.95 [0.69; 1.40], 1.01 [0.86; 1.55], 0.88 [0.71; 1.53], 0.87 [0.70; 1.22] mmol/l (p=0.002). The first administration of alirocumab at visit 3 was associated with the greatest reduction in LDL-C over the month (-34.1%; p=0.001).
Conclusion. The switch from inclisiran to alirocumab in post-ACS patients resulted in a rapid LDL-C reduction without any adverse events.
Keywords: acute coronary syndrome, lipid-lowering therapy, switching from inclisiran to alirocumab
Полный текст
Список литературы
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18. Hwang J, Nguyen D, Turer R, et al. Early experience of inclisiran: real-world analysis of utilization and lipid-lowering effects. European Heart Journal. 2026;46(Suppl. 1). DOI:10.1093/eurheartj/ehaf784.3725
19. Бойцов С.А., Проваторов С.И. Возможности улучшения госпитального и отдаленного прогнозов при нестабильной стенокардии. Терапевтический архив. 2024;96(1):5-10 [Boytsov SA, Provatorov SI. Possibilities for improving hospital and remote forecasts for unstable angina. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(1):5-10 (in Russian)]. DOI:10.26442/00403660.2024.01.202555
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2. Ezhov MV, Kukharchuk VV, Sergienko IV, et al. Disorders of lipid metabolism. Clinical Guidelines 2023. Russian Journal of Cardiology. 2023;28(5):5471 (in Russian). DOI:10.15829/1560-4071-2023-5471
3. Sergienko IV, Ezhov MV, Gurevich VS, et al. Comparative efficacy and safety of statins monotherapy and their combination with ezetimibe (Results of the Russian retrospective observational study UNISON). The Journal of Atherosclerosis and Dyslipidemias. 2022;4(49):25-38 (in Russian). DOI:10.34687/2219-8202.JAD.2022.04.0003
4. Mehta SR, Pare G, Lonn EM, et al. Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial. EuroIntervention. 2022;18(11):e888-86. DOI:10.4244/eij-d-22-00735
5. Trankle CR, Wohlford G, Buckley LF, et al. Alirocumab in Acute Myocardial Infarction: Results From the Virginia Commonwealth University Alirocumab Response Trial (VCU-AlirocRT). J Cardiovasc Pharmacol. 2019;74(3):266-9. DOI:10.1097/FJC.0000000000000706
6. Lunven C, Paehler T, Poitiers F, et al. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects. Cardiovasc Ther. 2014;32(6):297-301. DOI:10.1111/1755-5922.12093
7. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol. N Engl J Med. 2017;376(15):1430-40. DOI:10.1056/NEJMoa1615758
8. Toth PP, Bray S, Villa G, et al. Network Meta-Analysis of Randomized Trials Evaluating the Comparative Efficacy of Lipid-Lowering Therapies Added to Maximally Tolerated Statins for the Reduction of Low-Density Lipoprotein Cholesterol. J Am Heart Assoc. 2022;11(18):e025551. DOI:10.1161/JAHA.122.025551
9. Khattak S, Ochoa-Ferraro A, Khan N, et al. Relative Efficacy of Alirocumab, Evolocumab, Inclisiran, and Bempedoic Acid on Lipids in Patients with Cardiovascular Disease or Familial Hypercholesterolaemia. J Clin Med. 2025;14(22):7946. DOI:10.3390/jcm14227946
10. Jukema JW, Szarek M, Zijlstra LE, et al. Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial. J Am Coll Cardiol. 2019;74(9):1167-76. DOI:10.1016/j.jacc.2019.03.013
11. Bittner VA, Schwartz GG, Bhatt DL, et al. Alirocumab and cardiovascular outcomes according to sex and lipoprotein(a) after acute coronary syndrome: a report from the ODYSSEY OUTCOMES study. J Clin Lipidol. 2024;18(4):e548-61. DOI:10.1016/j.jacl.2024.04.122
12. Dutta S, Shah R, Singhal S, et al. A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients. Expert Opin Drug Saf. 2024;23(2):187-98. DOI:10.1080/14740338.2023.2293201
13. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023;11(2):109-19. DOI:10.1016/S2213-8587(22)00353-9
14. Mulder JWCM, Galema-Boers AMH, Roeters van Lennep JE. First clinical experiences with inclisiran in a real-world setting. J Clin Lipidol. 2023;17(6):818-27. DOI:10.1016/j.jacl.2023.09.005
15. Mazdeyasnan D, Birs A, Chiou T, et al. Insights from a real-world experience with inclisiran at a large United States lipid clinic. J Clin Lipidol. 2025;19(4):812-8. DOI:10.1016/j.jacl.2025.06.015
16. Korneva VA, Kuznetsova TY. Features of the management of patients during changing the drugs that affect proprotein convertase subtilisin/kexin type 9 (PCSK9). Kardiologiia. 2025;65(6):74-80 (in Russian). DOI:10.18087/cardio.2025.6.n2950
17. Makhmudova U, Schatz U, Perakakis N, et al. High interindividual variability in LDL-cholesterol reductions after inclisiran administration in a real-world multicenter setting in Germany. Clin Res Cardiol. 2023;112(11):1639-49. DOI:10.1007/s00392-023-02247-8
18. Hwang J, Nguyen D, Turer R, et al. Early experience of inclisiran: real-world analysis of utilization and lipid-lowering effects. European Heart Journal. 2026;46(Suppl. 1). DOI:10.1093/eurheartj/ehaf784.3725
19. Boytsov SA, Provatorov SI. Possibilities for improving hospital and remote forecasts for unstable angina. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(1):5-10 (in Russian). DOI:10.26442/00403660.2024.01.202555
20. Livori AC, Pol D, Levkovich B, Oqueli E. Optimising adherence to secondary prevention medications following acute coronary syndrome utilising telehealth cardiology pharmacist clinics: a matched cohort study. Int J Clin Pharm. 2023;45(3):722-30. DOI:10.1007/s11096-023-01562-4
2. Ежов М.В., Кухарчук В.В., Сергиенко И.В., и др. Нарушения липидного обмена. Клинические рекомендации 2023. Российский кардиологический журнал. 2023;28(5):5471 [Ezhov MV, Kukharchuk VV, Sergienko IV, et al. Disorders of lipid metabolism. Clinical Guidelines 2023. Russian Journal of Cardiology. 2023;28(5):5471 (in Russian)]. DOI:10.15829/1560-4071-2023-5471
3. Сергиенко И.В., Ежов М.В., Гуревич В.С., и др. Сравнительная эффективность и безопасность монотерапии статинами и их комбинации с эзетимибом (Результаты российского ретроспективного наблюдательного исследования УНИСОН). Атеросклероз и дислипидемии. 2022;4(49):25-38 [Sergienko IV, Ezhov MV, Gurevich VS, et al. Comparative efficacy and safety of statins monotherapy and their combination with ezetimibe (Results of the Russian retrospective observational study UNISON). The Journal of Atherosclerosis and Dyslipidemias. 2022;4(49):25-38 (in Russian)]. DOI:10.34687/2219-8202.JAD.2022.04.0003
4. Mehta SR, Pare G, Lonn EM, et al. Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial. EuroIntervention. 2022;18(11):e888-86. DOI:10.4244/eij-d-22-00735
5. Trankle CR, Wohlford G, Buckley LF, et al. Alirocumab in Acute Myocardial Infarction: Results From the Virginia Commonwealth University Alirocumab Response Trial (VCU-AlirocRT). J Cardiovasc Pharmacol. 2019;74(3):266-9. DOI:10.1097/FJC.0000000000000706
6. Lunven C, Paehler T, Poitiers F, et al. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects. Cardiovasc Ther. 2014;32(6):297-301. DOI:10.1111/1755-5922.12093
7. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol. N Engl J Med. 2017;376(15):1430-40. DOI:10.1056/NEJMoa1615758
8. Toth PP, Bray S, Villa G, et al. Network Meta-Analysis of Randomized Trials Evaluating the Comparative Efficacy of Lipid-Lowering Therapies Added to Maximally Tolerated Statins for the Reduction of Low-Density Lipoprotein Cholesterol. J Am Heart Assoc. 2022;11(18):e025551. DOI:10.1161/JAHA.122.025551
9. Khattak S, Ochoa-Ferraro A, Khan N, et al. Relative Efficacy of Alirocumab, Evolocumab, Inclisiran, and Bempedoic Acid on Lipids in Patients with Cardiovascular Disease or Familial Hypercholesterolaemia. J Clin Med. 2025;14(22):7946. DOI:10.3390/jcm14227946
10. Jukema JW, Szarek M, Zijlstra LE, et al. Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial. J Am Coll Cardiol. 2019;74(9):1167-76. DOI:10.1016/j.jacc.2019.03.013
11. Bittner VA, Schwartz GG, Bhatt DL, et al. Alirocumab and cardiovascular outcomes according to sex and lipoprotein(a) after acute coronary syndrome: a report from the ODYSSEY OUTCOMES study. J Clin Lipidol. 2024;18(4):e548-61. DOI:10.1016/j.jacl.2024.04.122
12. Dutta S, Shah R, Singhal S, et al. A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients. Expert Opin Drug Saf. 2024;23(2):187-98. DOI:10.1080/14740338.2023.2293201
13. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023;11(2):109-19. DOI:10.1016/S2213-8587(22)00353-9
14. Mulder JWCM, Galema-Boers AMH, Roeters van Lennep JE. First clinical experiences with inclisiran in a real-world setting. J Clin Lipidol. 2023;17(6):818-27. DOI:10.1016/j.jacl.2023.09.005
15. Mazdeyasnan D, Birs A, Chiou T, et al. Insights from a real-world experience with inclisiran at a large United States lipid clinic. J Clin Lipidol. 2025;19(4):812-8. DOI:10.1016/j.jacl.2025.06.015
16. Корнева В.А., Кузнецова Т.Ю. Особенности ведения пациентов при смене препаратов, влияющих на пропротеинконвертазу субтилизин / кексин 9 го типа (PCSK9). Кардиология. 2025;65(6):74-80 [Korneva VA, Kuznetsova TY. Features of the management of patients during changing the drugs that affect proprotein convertase subtilisin/kexin type 9 (PCSK9). Kardiologiia. 2025;65(6):74-80 (in Russian)]. DOI:10.18087/cardio.2025.6.n2950
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18. Hwang J, Nguyen D, Turer R, et al. Early experience of inclisiran: real-world analysis of utilization and lipid-lowering effects. European Heart Journal. 2026;46(Suppl. 1). DOI:10.1093/eurheartj/ehaf784.3725
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13. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023;11(2):109-19. DOI:10.1016/S2213-8587(22)00353-9
14. Mulder JWCM, Galema-Boers AMH, Roeters van Lennep JE. First clinical experiences with inclisiran in a real-world setting. J Clin Lipidol. 2023;17(6):818-27. DOI:10.1016/j.jacl.2023.09.005
15. Mazdeyasnan D, Birs A, Chiou T, et al. Insights from a real-world experience with inclisiran at a large United States lipid clinic. J Clin Lipidol. 2025;19(4):812-8. DOI:10.1016/j.jacl.2025.06.015
16. Korneva VA, Kuznetsova TY. Features of the management of patients during changing the drugs that affect proprotein convertase subtilisin/kexin type 9 (PCSK9). Kardiologiia. 2025;65(6):74-80 (in Russian). DOI:10.18087/cardio.2025.6.n2950
17. Makhmudova U, Schatz U, Perakakis N, et al. High interindividual variability in LDL-cholesterol reductions after inclisiran administration in a real-world multicenter setting in Germany. Clin Res Cardiol. 2023;112(11):1639-49. DOI:10.1007/s00392-023-02247-8
18. Hwang J, Nguyen D, Turer R, et al. Early experience of inclisiran: real-world analysis of utilization and lipid-lowering effects. European Heart Journal. 2026;46(Suppl. 1). DOI:10.1093/eurheartj/ehaf784.3725
19. Boytsov SA, Provatorov SI. Possibilities for improving hospital and remote forecasts for unstable angina. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(1):5-10 (in Russian). DOI:10.26442/00403660.2024.01.202555
20. Livori AC, Pol D, Levkovich B, Oqueli E. Optimising adherence to secondary prevention medications following acute coronary syndrome utilising telehealth cardiology pharmacist clinics: a matched cohort study. Int J Clin Pharm. 2023;45(3):722-30. DOI:10.1007/s11096-023-01562-4
Авторы
А.А. Некрасов1,2, Е.С. Тимощенко2, С.Г. Ерофеева2, Е.С. Кузякина1, Т.А. Некрасова*1
1ФГБОУ ВО «Приволжский исследовательский медицинский университет» Минздрава России, Нижний Новгород, Россия;
2ГБУЗ НО «Городская клиническая больница №5 Нижегородского района города Нижнего Новгорода», Нижний Новгород, Россия
*tatnecrasova@yandex.ru
1Privolzhsky Research Medical University, Nizhniy Novgorod, Russia;
2City Clinical Hospital No. 5, Nizhniy Novgorod, Russia
*tatnecrasova@yandex.ru
1ФГБОУ ВО «Приволжский исследовательский медицинский университет» Минздрава России, Нижний Новгород, Россия;
2ГБУЗ НО «Городская клиническая больница №5 Нижегородского района города Нижнего Новгорода», Нижний Новгород, Россия
*tatnecrasova@yandex.ru
________________________________________________
1Privolzhsky Research Medical University, Nizhniy Novgorod, Russia;
2City Clinical Hospital No. 5, Nizhniy Novgorod, Russia
*tatnecrasova@yandex.ru
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