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PCSK9 Inhibitors in Clinical Practice: Experience of a Specialized Lipid Center


Aim. To characterize patients receiving PCSK9 inhibitors, and assess the efficiency of their treatment in a specialized lipid center.

Material and methods. A retrospective analysis of the medical records of patients who visited the Lipid clinic of the National Medical Research Center for Therapy and Preventive Medicine (Moscow, Russia), receiving PCSK9 inhibitor and having lipid profile in dynamics, was carried out (n=77). Cardiovascular risk (CVR) and low-density lipoprotein cholesterol (LDL-C) target levels were evaluated in accordance with the Russian guidelines for the diagnostics and correction of dyslipidemias 2020.

Results. Of 77 patients taking PCSK9 inhibitors (44.2% males, the median of age 56 [47; 66] years), the majority (64.0%) had a probable or definite familial hypercholesterolemia (FH). The proportion of other lipid metabolism disorders, pure hypercholesterolemia and combined hyperlipidemia was 21% and 15%. More than half of the patients (68.8%) had a very high CVR, mainly due to the presence of coronary heart disease (84.9%). The proportion of patients receiving PCSK9 inhibitors as monotherapy was 7.8%, in combination with high-intensity statin therapy – 33.8%, as part of triple lipid-lowering therapy (high-intensity statin, ezetimibe, PCSK9 inhibitors) – 50.6%. Addition of PCSK9 inhibitors to combined lipid-lowering therapy enabled to reduce the LDL-C level to 1.02 [0.62; 1.39] mmol/l with its total decrease from the baseline by 87.3%. While taking PCSK9 inhibitors, LDL-C <1.8 mmol/l and <1.4 mmol/l achieved at 78.3% and 57.7% FH patients with high and very high CVR, respectively. Among patients with other hyperlipidemias, 74.1% of patients with very high CVR was achieved the target LDL-C level <1.4 mmol/l.

Conclusion: In a specialized lipid center, PCSK9 inhibitors are prescribed to patients with high or very high CVR, most of whom are FH patients. The effectiveness of the use of PCSK9 inhibitors in real-world practice is comparable to the results of clinical trials.

About the Authors

A. V. Blokhina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Anastasia V. Blokhina.


eLibrary  SPIN  1103-6168

A. I. Ershova
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Alexandra I. Ershova.


eLibrary  SPIN  5292-5612

A. S. Limonova
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Alena S. Limonova.


eLibrary  SPIN  1762-2462

O. V. Kopylova
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Oxana V. Kopylova.


eLibrary  SPIN  9127-0692

A. N. Meshkov
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Alexey N. Meshkov.


eLibrary  SPIN  6340-5187

O. M. Drapkina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Oxana M. Drapkina.


eLibrary  SPIN  4456-1297


1. Townsend N, Wilson L, Bhatnagar P, et al. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016;37(42):3232-45. DOI:10.1093/EURHEARTJ/EHW334.

2. Ference B, Ginsberg H, 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.

3. Mach F, Baigent C, Catapano ALб et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2020;41(1):111-88. DOI:10.1093/EURHEARTJ/EHZ455.

4. Kukharchuk VV, Ezhov MV, Sergienko IV, et al. Diagnostics and correction of lipid metabolism disorders in order to prevent and treat of atherosclerosis Russian recommendations VII revision. Atherosclerosis and Dyslipisemias. 2020;1(38):7-40 (In Russ) DOI:10.34687/2219-8202.JAD.2020.01.0002.

5. Civeira F. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004;173(1):55-68. DOI:10.1016/j.atherosclerosis.2003.11.010.

6. Zafrir B, Jubran A. Lipid‐lowering therapy with PCSK 9‐inhibitors in the real‐world setting: Two‐year experience of a regional lipid clinic. Cardiovascular Therapeutics. 2018;36(5):e12439. DOI:10.1111/1755-5922.12439.

7. Rane PB, Patel J, Harrison DJ, et al. Patient Characteristics and Real-World Treatment Patterns Among Early Users of PCSK9 Inhibitors. Am J Cardiovasc Drugs. 2018;18(2):103-8. DOI:10.1007/s40256-017-0246-z.

8. Jensen JS, Weeke PE, Bang LE, et al. Clinical characteristics and lipid lowering treatment of patients initiated on proprotein convertase subtilisin-kexin type 9 inhibitors: a nationwide cohort study. BMJ Open. 2019;9(4):e022702. DOI:10.1136/bmjopen-2018-022702.

9. Turgeon RD, Tsuyuki RT, Gyenes GT, Pearson GJ. Cardiovascular Efficacy and Safety of PCSK9 Inhibitors: Systematic Review and Meta-analysis Including the ODYSSEY OUTCOMES Trial. Can J Cardiol. 2018;34(12):1600-5. DOI:10.1016/j.cjca.2018.04.002.

10. Matta A, Bongard V, Bouisset F, et al. Real-World Efficacy of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9i) in Heterozygous Familial Hypercholesterolemia Patients Referred for Lipoprotein Apheresis. Medical Science Monitor: International Medical Journal of Experimental and Clinical Research. 2021;27:e928784-1. DOI:10.12659/MSM.928784.

11. Stoekenbroek RM, Hartgers ML, Rutte R, et al. PCSK9 inhibitors in clinical practice: Delivering on the promise? Atherosclerosis. 2018;270:205-10. DOI:10.1016/j.atherosclerosis.2017.11.027.

12. Beheshti SO, Madsen CM, Varbo A, Nordestgaard BG. Worldwide prevalence of familial hypercholesterolemia: meta-analyses of 11 million subjects. J Am Coll Cardiol. 2020;75(20):2553-66. DOI:10.1016/j.jacc.2020.03.057.

13. Meshkov AN, Ershova AI, Kiseleva AV, et al. The Prevalence of Heterozygous Familial Hypercholesterolemia in Selected Regions of the Russian Federation: The FH-ESSE-RF Study. J Pers Med. 2021;11(6):464. DOI:10.3390/jpm11060464.

14. Ezhov MV, Bazhan SS, Ershova AI, et al. Clinical guidelines for familial hypercholesterolemia. Ateroscleroz. 2019;15(1):58-98 (In Russ.)

15. Piccinni C, Antonazzo IC, Maggioni AP, et al. PCSK9 Inhibitors' New Users: Analysis of Prescription Patterns and Patients' Characteristics from an Italian Real-world Study. Clin Drug Investig. 2020;40(2):173-81. DOI:10.1007/s40261-019-00877-3.

16. Schmidt AF, Pearce LS, Wilkins JT, et al. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews. 2017;4(4):CD011748. DOI:10.1002/14651858.CD011748.pub2.

17. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376(18):1713-22. DOI:10.1056/NEJMoa1615664.

18. Schwartz GG, Steg PG, 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.

19. Blokhina AV, Ershova AI, Meshkov AN, et al. Lipid Clinic is an Efficacious Model of Preventive Medicine. Rational Pharmacotherapy in Cardiology 2021;17(1):4-10 (in Russ) DOI:10.20996/1819-6446-2021-01-02.

20. Pechlivanis S, Mahabadi AA, Hoffmann P, et al. Association between lipoprotein (a)(Lp (a)) levels and Lp (a) genetic variants with coronary artery calcification. BMC Med Genet. 2020;21(1):1-10. DOI:10.1186/s12881-020-01003-3.

21. Gaudet D, Watts GF, Robinson JG, et al. Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program). Am J Cardiol. 2017;1;119(1):40-6. DOI:10.1016/j.amjcard. 2016.09.010.

22. Raal FJ, Giugliano RP, Sabatine MS, et al. Reduction in lipoprotein(a) with PCSK9 monoclonal antibody evolocumab (AMG 145): a pooled analysis of more than 1,300 patients in 4 phase II trials. J Am Coll Cardiol. 2014;8;63(13):1278-88. DOI:10.1016/j.jacc.2014.01.006.


For citations:

Blokhina A.V., Ershova A.I., Limonova A.S., Kopylova O.V., Meshkov A.N., Drapkina O.M. PCSK9 Inhibitors in Clinical Practice: Experience of a Specialized Lipid Center. Rational Pharmacotherapy in Cardiology. 2021;17(6):808-815. (In Russ.)

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ISSN 1819-6446 (Print)
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