Alirocumab in patients of very high cardiovascular risk


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Abstract

In the present review, the focus is on the rationale for proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors in the dyslipidemia correction in patients with very high and extreme cardiovascular risk.

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About the authors

Olga I. Boeva

Central State Medical Academy of the Presidential Executive Office

Email: box0271@mail.ru
MD, PhD, DMSci., professor of the Department of therapy, cardiology and functional diagnostics with the course of nephrology Moscow

Valentin A. Kokorin

N.I. Pirogov Russian National Research Medical University

Email: valentinkokorin@yahoo.com
MD, PhD, DMSci., professor of the Department of hospital therapy Moscow

References

  1. Awan Z., Seidah N.G., MacFadyen J.G. et al. Rosuvastatin, proprotein convertase subtilisin/kexin type 9 concentrations, and LDL cholesterol response: the JUPITER trial. Clin Chem. 2012; 58(1): 183-89. doi: 10.1373/clinchem.2011.172932.
  2. Welder G., Zineh I., Pacanowski M.A. et al. High-dose atorvastatin causes a rapid sustained increase in human serum PCSK9 and disrupts its correlation with LDL cholesterol. J Lipid Res. 2010; 51(9): 2714-21. doi: 10.1194/jlr.M008144.
  3. Stein E.A., Mellis S., Yancopoulos G.D. et al. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012; 366(12): 1108-18. doi: 10.1056/NEJMoa1105803.
  4. Dias C.S., Shaywitz A.J., Wasserman S.M. et al. Effects of AMG145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins. J Am Coll Cardiol. 2012; 60(19): 1888-98. doi: 10.1016/j.jacc.2012.08.986.
  5. ClinicalTrials.gov. The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-2) [Internet]. Available at: https://clinicaltrials.gov/ct2/show/NCT01975389 (cited 2013 October 21).
  6. Norata G.D., Tibolla G., Catapano A.L. Targeting PCSK9 for hypercholesterolemia. Annu Rev Pharmacol Toxicol. 2014; 54: 273-93. doi: 10.1146/annurev-pharmtox-011613-140025.
  7. Abifadel M., Varret M., Rabes J.-P. et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003; 34(2): 154-56. doi: 10.1038/ng1161.41.
  8. Shimada Y.J., Cannon C.P. PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitors: past, present, and the future. Eur Heart J. 2015; 36(36): 2415-24. doi: 10.1093/eurheartj/ehv174.
  9. Кухарчук В.В., Ежов М.В., Сергиенко И.В. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Российские рекомендации, VII пересмотр. Атеросклероз и дислипидемии. 2020; 1: 7-42
  10. Mach F., Baigent C., Catapano A.L. et al. ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020; 41(1): 111-88. doi: 10.1093/eurheartj/ehz455.
  11. Schmidt A.F., Carter J.-P.L., Pearce L.S. et al. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020; 10(10): CD011748. doi: 10.1002/14651858.CD011748.pub3.
  12. Ference B.A., Ginsberg H.N., 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(32): 2459-72. doi: 10.1093/eurheartj/ehx144.
  13. Catapano A.L., Graham I., De Backer G. et al. 2016 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2016; 37(39): 2999-3058. doi: 10.1093/eurheartj/ehw272.
  14. McKenney J.M., Koren M.J., Kereiakes D.J. et al. Safety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy. J Am Coll Cardiol. 2012; 59(25): 2344-53. doi: 10.1016/j.jacc.201 2.03.007.
  15. Schwartz G.G., Bessac L., Berdan L.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(5): 682-89. doi: 10.1016/j.ahj.2014.07.028.
  16. Landmesser U., Chapman M.J., Stock J.K. et al. 2017 Update of ESC/EAS Task Force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia. Eur Heart J. 2018; 39(14): 1131-43. doi: 10.1093/eurheartj/ehx549.
  17. Stein E.A., Gipe D., Bergeron J. et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet. 2012; 380(9836): 29-36. doi: 10.1016/S0140-6736(12)60771-5.
  18. Teramoto T., Kobayashi M., Uno K. et al. Efficacy and Safety of Alirocumab in Japanese Subjects (Phase 1 and 2 Studies). Am J Cardiol. 2016; 118(1): 56-63. doi: 10.1016/j.amjcard.2016.04.011.
  19. Инструкция по медицинскому применению лекарственного препарата Пралуэнт, раствор для подкожного введения, 75 или 150 мг/мл. РУ № ЛП-004078 (АО «Санофи-Авентис Груп», Франция). Доступ: https://grls.rosminzdrav.ru/Grls_View_v2_aspx?routingGuid=72fb3609-34cf-40e6-b158-50d388a4d0d8&t= (дата обращения - 01.09.2021).
  20. Greig S.L., Deeks E.D. Alirocumab: a review in hypercholesterolemia. Am J Cardiovasc Drugs. 2016; 16(2): 141-52. doi: 10.1007/s40256-016-0166-3.
  21. Tsimikas S., Fazio S., Ferdinand K.C. et al. NHLBI Working Group recommendations to reduce lipoprotein(a)-mediated risk of cardiovascular disease and aortic stenosis. J Am Coll Cardiol. 2018; 71(2): 177-92. doi: 10.1016/j.jacc.2017.11.014.
  22. Cannon C.P., Braunwald E., McCabe C.H. et al.Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004; 350(15): 1495-504. doi: 10.1056/NEJMoa040583.
  23. Wiviott S.D., Cannon C.P., Morrow D.A. et al. Can low-density lipoprotein be too low? The safety and efficacy of achieving very low low-density lipoprotein with intensive statin therapy: a PROVE IT-TIMI 22 substudy. J Am Coll Cardiol. 2005; 46(8): 1411-16. doi: 10.1016/j.jacc.2005.04.064.
  24. Szarek M., White H.D., Schwartz G.G. Alirocumab reduces total nonfatal cardiovascular and fatal events: The ODYSSEY OUTCOMES trial. J Am Coll Cardiol. 2019; 73(4): 387-96. doi: 10.1016/j.jacc.2018.10.039.
  25. Steg P.G., Szarek M., Bhatt D.L. et al. Effect of alirocumab on mortality after acute coronary syndromes. Circulation. 2019; 140(2): 103-12. doi: 10.1161/CIRCULATIONAHA.118.038840.
  26. Kearney P.M., Blackwell L., Collins R. et al.; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008; 371(9607): 117-25. doi: 10.1016/S0140-6736(08)60104-X.
  27. Ginsberg H.N., Elam M.B., Lovato L.C. et al. ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010; 362(17): 1563-74. doi: 10.1056/NEJMoa1001282.
  28. Boekholdt S.M., Hovingh G.K., Mora S. et al. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a metaanalysis of statin trials. J Am Coll Cardiol. 2014; 64(5): 485-94. doi: 10.1016/j.jacc.2014.02.615.
  29. Cannon C.P., Blazing M.A., Giugliano R.P. et al. IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015; 372(25): 2387-97. doi: 10.1056/NEJMoa1410489.
  30. Keech A., Simes R.J., Barter P. et al. Field Study Investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005; 366(9500): 1849-61. doi: 10.1016/S0140-6736(05)67667-2.
  31. Roth E.M., Taskinen M.R., Ginsberg H.N. et al. Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: results of a 24 week, double-blind, randomized phase 3 trial.Int J Cardiol. 2014; 176(1): 55-61. doi: 10.1016/j.ijcard.2014.06.049.
  32. Moriarty P.M., Thompson P.D., Cannon C.P. et al. Efficacy and safety of alirocumab versus ezetimibe in statin-intolerant patients, with a statin rechallenge arm: the ODYSSEY ALTERNATIVE randomized trial. J Clin Lipidol. 2015; 9(6): 758-69. doi: 10.1016/j.jacl.201 5.08.006.
  33. Stroes E., Guyton J.R., Farnier M. et al. for the ODYSSEY CHOICE II investigators. Efficacy and safety of alirocumab 150 mg every 4 weeks in patients with hypercholesterolemia not on statin therapy: the ODYSSEY CHOICE II study. J Am Heart Assoc. 2016; 5(9): e003421. doi: 10.1161/JAHA.116.003421.
  34. Kastelein J.J., Ginsberg H.N., Langslet G. et al. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolemia. Eur Heart J. 2015; 36(43): 2996-3003. doi: 10.1093/eurheartj/ehv370.
  35. Ginsberg H.N., Rader D.J., Raal F.J. et al. Efficacy and safety of alirocumab in patients with severe heterozygous familial hypercholesterolemia. Cardiovasc Drugs Ther. 2016; 30(5): 473-83. doi: 10.1007/s10557-016-6685-y.
  36. Schwartz G.G., Steg P.G., Szarek M. et al. ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018; 379(22): 2097-107. doi: 10.1056/NEJMoa1801174.
  37. Jernberg T., Hasvold P., Henriksson M. et al. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015; 36(19): 1163-70. doi: 10.1093/eurheartj/ehu505.
  38. Zhao S., Wang Y., Mu Y. et al. Prevalence of dyslipidaemia in patients treated with lipid-lowering agents in China: results of the DYSlipidemia International Study (DYSIS). Atherosclerosis. 2014; 235(2): 463-69. doi: 10.1016/j.atherosclerosis.2014.05.916.
  39. Reiner Z., De Backer G., Fras Z. et al. Lipid lowering drug therapy in patients with coronary heart disease from 24 European countries - findings from the EUROASPIRE IV survey. Atherosclerosis. 2016; 246: 243-50. doi: 10.1016/j.atherosclerosis.2016.01.018.
  40. De Backer G., Jankowski P., Kotseva K. Management of dyslipidaemia in patients with coronary heart disease: Results from the ESC-EORP EUROASPIRE V survey in 27 countries. Atherosclerosis. 2019; 285: 135-46. doi: 10.1016/j.atherosclerosis.2019.03.014
  41. Gitt A.K., Drexel H., Feely J. et al. Persistent lipid abnormalities in statin-treated patients and predictors of LDL-cholesterol goal achievement in clinical practice in Europe and Canada. Eur J Prevent Cardiol. 2012; 19(2): 221-30. doi: 10.1177/1741826711400545.
  42. Benn M., Watts G.F., Tybjaerg-Hansen A. et al. Familial hypercholesterolemia in the Danish general population: prevalence, coronary artery disease, and cholesterol-lowering medication. J Clin Endocrinol Metab. 2012; 97(11): 3956-64. doi: 10.1210/jc.2012-1563.
  43. Nanchen D., Gencer B., Auer R. et al. Prevalence and management of familial hypercholesterolemia in patients with acute coronary syndromes. Eur Heart J. 2015; 36(36): 2438-45. doi: 10.1093/eu-rheartj/ehv289.
  44. Ежов М.В., Лазарева Н.В., Сагайдак О.В. с соавт. Частота нарушений липидного обмена и применение статинов при остром коронарном синдроме (по данным Федерального Регистра острого коронарного синдрома). Атеросклероз и дислипиде-мии. 2018; 1: 47-57.
  45. Россия в цифрах - 2019. Краткий статистический сборник. М.: Росстат. 2019. [Russia in Figures 2019. Brief statistical book. Moscow: Rosstat. 2019 (In Russ.)].
  46. Nordestgaard B.G., Chapman M.J., Humphries S.E. et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: Guidance for clinicians to prevent coronary heart disease: Consensus statement of the European Atherosclerosis Society. Eur Heart J. 2013; 34(45): 3478-3490a. doi: 10.1093/eurheartj/eht273.
  47. Дедов И.И., Александров A.A. Проблемы острого инфаркта миокарда у больных сахарным диабетом. Сахарный диабет. 2008; 1: 4-10.
  48. Какорин С.В., Тулякова Э.В., Воронкова К.В., Мкртумян А.М. Острое нарушение мозгового кровообращения у больных сахарным диабетом 2 типа. Сахарный диабет. 2013; 1: 63-70
  49. Sarwar N., Gao P., Seshasai S.R. et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: A collaborative meta-analysis of 102 prospective studies. Lancet. 2010; 375(9733): 2215-22. doi: 10.1016/S0140-6736(10)60484-9.
  50. Simpson S.H., Lin M., Eurich D.T.Community pharmacy-based inducement programs associated with better medication adherence: a cohort study. Ann Pharmacother. 2017; 51(8): 630-39. doi: 10.1177/1060028017703720.
  51. Голухова Е.З., Кузнецова Е.В. Реваскуляризация миокарда у больных ИБС в сочетании с сахарным диабетом 2-го типа: обзор современных технологий. Сахарный диабет. 2016; 5: 406-13
  52. Ярбеков Р.Р., Чигогидзе Н.А., Сигаев И.Ю., Керен М.А. Ближайшая и отдаленная эффективность чрескожного коронарного вмешательства у больных ИБС с многососудистым поражением коронарных артерий и сахарным диабетом II типа. Анналы хирургии. 2014; 5: 21-26
  53. Толпыгина С.Н., Марцевич С.Ю. Изучение динамики частоты приема основных классов лекарственных препаратов, показанных при лечении пациентов с хронической ишемической болезнью сердца, с 2004 по 2014 г. данные регистра прогноз ИБС. Клиницист. 2016; 1: 29-35
  54. Vonbank A., Agewall S., Kjeldsen K.P. et al.Comprehensive efforts to increase adherence to statin therapy. Eur Heart J. 2017; 38(32): 2473-79. doi: 10.1093/eurheartj/ehw628.
  55. Krempf M., Simpson R.J., Ramey D.R. et al. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015; 14(1): 45-47. doi: 10.1186/s12944-015-0037-y.
  56. Недогода С.В., Чумачек Е.В., Саласюк А.С. Обоснование применения алирокумаба при остром коронарном синдроме с клинико-экономической точки зрения. Клиническая фармакология и терапия. 2019; 2: 99-104
  57. Зырянов С.К., Дьяков И.Н. Прогнозный экономический эффект применения алирокумаба у пациентов с гиперхолестеринемией и высоким сердечно-сосудистым риском. Клиническая фармакология и терапия. 2018; 1: 90-96

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