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Inhibitors in the Management of Patients with Atherosclerotic Cardiovascular Diseases: Guidelines and Reimbursement Issues

https://doi.org/10.20996/1819-6446-2020-08-21

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Abstract

Current guidelines for the management of patients with dyslipidemia define low-density lipoprotein cholesterol (LDL-C) as the primary target in addressing lipid-lowering therapy. The target level of LDL-C in real clinical practice is achieved in no more than a third of patients who have undergone a coronary event and receive high-intensity lipid-lowering therapy. Achieving the goals of lipid-lowering therapy in a significant proportion of patients with atherosclerotic cardiovascular diseases (ACVD) is impossible with the use of even high doses of statins, which requires its enhancement by other drugs. The article considers the place of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in the prevention of cardiovascular diseases in patients with ACVD in accordance with the latest Russian and international guidelines. A modern decision-making algorithm for the initiation of PCSK9 inhibitors therapy in patients with ACVD is presented. The authors provide a clear understanding about the patient populations that will benefit most from the taking of PCSK9 inhibitors. Particular attention is paid to Guidelines for the management of dyslipidemias developed by European Society of Cardiology and European Atherosclerosis Society in 2019. The issues of patients provision with PCSK9 inhibitors with reference to Russian conditions are described in details in accordance with the requirements for territorial programs of state guarantees. Further improvement in the provision of PCSK9 inhibitors to patients with indications for this therapy is necessary, considering the potential of these drugs in reducing cardiovascular morbidity and mortality in patients with ACVD.

About the Authors

M. V. Zhuravleva
Scientific Center for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Marina V. Zhuravleva – MD, PhD, Professor, Deputy Director, Center for Clinical Pharmacology, Scientific Center for Expert Evaluation of Medicinal Products; Professor, Chair of Clinical Pharmacology and Propedeutics of Internal Diseases, Sechenov University

Petrovskii bulv. 8-2, Moscow, 127051,

Trubetskaya ul. 8-2, Moscow, 119991



A. B. Prokofiev
Scientific Center for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Alexey B. Prokofiev – MD, PhD, Director, Center for Clinical Pharmacology, Scientific Center for Expert Evaluation of Medicinal Products; Professor, Chair of Clinical Pharmacology and Propedeutics of Internal Diseases, Sechenov University

Petrovskii bulv. 8-2, Moscow, 127051,

Trubetskaya ul. 8-2, Moscow, 119991



E. V. Shikh
Scientific Center for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Evgenia V. Shikh – MD, PhD, Professor, Head of Chair of Clinical Pharmacology and Propaedeutics of Internal Medicine, Director of Institute of Professional Education, Sechenov University

Petrovskii bulv. 8-2, Moscow, 127051,

Trubetskaya ul. 8-2, Moscow, 119991



S. Yu. Serebrova
Scientific Center for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Svetlana Yu. Serebrova – MD, PhD, Chief Researcher, Scientific Center for Expert Evaluation of Medicinal Products; Professor, Chair of Clinical Pharmacology and Propedeutics of Internal Diseases, Sechenov University

Petrovskii bulv. 8-2, Moscow, 127051,

Trubetskaya ul. 8-2, Moscow, 119991



G. I. Gorodetskaya
Scientific Center for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Galina I. Gorodetskaya – MD, PhD, Leading Analyst, Scientific Center for Expert Evaluation of Medicinal Products; Assistant, Chair of Clinical Pharmacology and Propaedeutics of Internal Medicine, Sechenov University

Petrovskii bulv. 8-2, Moscow, 127051,

Trubetskaya ul. 8-2, Moscow, 119991



E. Yu. Demchenkova
Scientific Center for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Elena Yu. Demchenkova – PhD (Pharmacology), Senior Analyst, Scientific Center for Expert Evaluation of Medicinal Products; Senior Assistant, Chair of Clinical Pharmacology and Propaedeutics of Internal Medicine, Sechenov University

Petrovskii bulv. 8-2, Moscow, 127051,

Trubetskaya ul. 8-2, Moscow, 119991



References

1. 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.

2. Diagnostics and correction of lipid metabolism disorders in order to prevent and treat atherosclerosis. Russian guidelines (VI revision). Atherosclerosis and Dyslipidemia. 2017;3:5-22 (In Russ.)

3. Mach F., Baigent C., Catapano A.L., et al. 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.

4. Grundy S.M., Stone N.J., Bailey A.L., et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):e285-e350. DOI:10.1016/j.jacc.2018.11.003.

5. 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.

6. Aronov D.M., Arabidze G. G., Akhmedzhanov N.M., et al. Diagnosis and correction of lipid metabolism disorders for the prevention and treatment of atherosclerosis. Russian recommendations, 2012 [cited by Jul 10, 2020]. Available from: https://scardio.ru/content/Guidelines/rek_lipid_2012.pdf (In Russ.)

7. Sabatine M.S., Wiviott S.D., Im K., et al. Efficacy and safety of further lowering of low-density lipoprotein cholesterol in patients starting with very low levels: a meta-analysis. JAMA Cardiol. 2018;3(9):823-8. DOI:10.1001/jamacardio.2018.2258.

8. Schwartz G.G., Steg P.G., Szarek M., et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):2097-107. DOI:10.1056/NEJMoa1801174.

9. Kotseva K. Reaching lipid targets in coronary patents - Temporal trends and state of the art. Presented at ESC 2018, Munich [cited by Jul 10, 2020] Available from: https://esc365.escardio.org/Congress/ESC-Congress-2018/Implementation-of-cardiovascular-disease-prevention-in-dailypractice-Insig/174542-reaching-lipid-targets-in-coronary-patents-temporal-trends-and-stateof-the-art#slide.

10. 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 ITTIMI 22 substudy. J Am Coll Cardiol. 2005;46(8):1411-6. DOI:10.1016/j.jacc.2005.04.064.

11. Abifadel M., Varret M., Rabès J.P., et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003;34(2):154-6. DOI:10.1038/ng1161.

12. Brown M.S., Anderson R.G., Goldstein J.L. Recycling receptors: the round-trip itinerary of migrant membrane proteins. Cell. 1983;32(3):663-7. DOI:10.1016/0092-8674(83)90052-1.

13. Seidah N.G., Awan Z., Chrétien M., et al. PCSK9: a key modulator of cardiovascular health. Circ Res. 2014;114(6):1022-36. DOI:10.1161/CIRCRESAHA.114.301621.

14. Instructions for use of the drug for medical use of Praluent [cited by Jul 10, 2020]. Available from: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=ac6be197-2ce4-4e0f-9577-bf5e55ad2d2a&t= (In Russ.)

15. Instructions for use of the drug for medical use of Repatha [cited by Jul 10, 2020]. Available from: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=1939ecad-6fb8-4a15-8479-d97a45adba6b&t= (In Russ.)

16. Roth E.M., Diller P. Alirocumab for hyperlipidemia: physiology of PCSK9 inhibition, pharmacodynamics and Phase I and II clinical trial results of a PCSK9 monoclonal antibody. Future Cardiol. 2014;10(2):183-99. DOI:10.2217/fca.13.107.

17. Schmidt A.F., Pearce L.S., Wilkins J.T., et al. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017;4(4):CD011748. DOI:10.1002/14651858.CD011748.pub2.

18. Zhuravleva M.V., Kokushkin K.A., Prokofiev A.B., et al. PCSK9 inhibitors in real clinical practice: to whom, when and how? Cardiology: News, Opinions, Training. 2018;6(3):31-40 (In Russ.) DOI:10.24411/2309-1908-2018-13002.

19. Cannon C.P., Khan I., Klimchak A.C., et al. Simulation of lipid-lowering therapy intensification in a population with atherosclerotic cardiovascular disease. JAMA Cardiol. 2017;2(9):959-66. DOI:10.1001/jamacardio.2017.2289.

20. Galstyan G.R., Galyavich A.S., Grineva E.N., et al. Lipid-lowering treatment in the improvement of outcomes in patients with atherosclerotic cardiovascular disease and diabetes mellitus: the role of PCSK9 inhibitors. Russian Journal of Cardiology. 2018;23(12):103-6. DOI:10.15829/1560-4071-2018-12-103-106 (In Russ.) DOI:10.15829/1560-4071-2018-12-103-106].

21. Resolution of the Government of the Russian Federation (July 30, 1994) No 890 "On state support for the development of the medical industry and improving the provision of the population and health care institutions with medicines and medical devices (as amended). "Assembly of Legislation of the Russian Federation", 1994, No 15, Article 1791. Russian News. №148, 10.08.1994 (In Russ.)

22. Resolution of the Government of the Russian Federation (December 10, 2018) No 1506 “About the Program of state guarantees of free medical care to citizens for 2019 and for the planning period of 2020 and 2021”. The text of the resolution was published on the "Official Internet portal of legal information" [cited by Jul 10, 2020]. Available on: http://publication.pravo.gov.ru/Document/View/0001201812110017 (In Russ.)

23. Order of the Government of the Russian Federation of December 10, 2018. No. 2738-p “About the statement of the list of vital and most important medicines for medical use for 2019” [cited Jul 10, 2020]. Available from: https://base.garant.ru/72123048/ (In Russ.)

24. Stable Coronary Heart Disease. 2016 Clinical Guidelines (Russian Society of Cardiology / Russian National Atherosclerosis Society / Atherothrombosis National Society) [cited by Jul 10, 2020]. Available on: http://cr.rosminzdrav.ru/schema.html?id=133#/part/7 (In Russ.)

25. Familiar Hypercholesterolemia. 2018 National Clinical Guidelines [cited by Jul 10, 2020] Available on: http://cr.rosminzdrav.ru/#!/recomend/940 (In Russ.)

26. Order of the Ministry of Health and Social Development of the Russian Federation (May 5, 2012) No. 502n “About approval of the procedure for establishing and operating a medical commission of a medical organization” (as amended by the Order of the Ministry of Health of the Russian Federation dated 02.12.2013 No. 886n). Registered in the Ministry of Justice of the Russian Federation on Jun 2020, No24516. Rossiyskaya Gazeta. 2012;141 (In Russ.)

27. Order of the Ministry of Health of the Russian Federation (December 2, 2014) No 796n “About approval of the Regulations on the organization of specialized, including high-tech, medical care.” Registered in the Ministry of Justice of the Russian Federation on February 2, 2015, No35821. Rossiyskaya Gazeta. 2015;30 (In Russ.)

28. Ziryanov S.K., Diakov I.N. Expected economic effect of the alirocumab administration in patients with hypercholesterolemia and high cardiovascular risk. Clin Pharmacol Ther. 2018;27(1):90-6 (In Russ.)


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For citations:


Zhuravleva M.V., Prokofiev A.B., Shikh E.V., Serebrova S.Yu., Gorodetskaya G.I., Demchenkova E.Yu. Inhibitors in the Management of Patients with Atherosclerotic Cardiovascular Diseases: Guidelines and Reimbursement Issues. Rational Pharmacotherapy in Cardiology. 2020;16(4):644-653. (In Russ.) https://doi.org/10.20996/1819-6446-2020-08-21

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ISSN 1819-6446 (Print)
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