Efficacy and safety of the use of alirocumab in real clinical practice

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Abstract

Aim. To evaluate the results of two-year use of alirokumab in Karelia Republic.

Materials and methods. The observation group consisted of 27 patients (17 patients with familial hypercholesterolemia, 10 patients with the history of myocardial infarction), mean age 53.4±4.3 years, 70.3% men, follow-up duration from one year to 2.5 years, 18 (66.6%) patients received therapy for more than 2 years. 19 patients received alirocumab at a dose of 75 mg/ml once every 2 weeks, eight – at a dose of 150 mg/ml once every 2 weeks. Before the start of therapy, the majority received maximally tolerated statin therapy, 10 patients received statin therapy in combination with ezetemibe, 3 patients received ezetemibe monotherapy due to statin intolerance. The target levels of LDL cholesterol were considered for very high risk patients less than 1.4 mmol/L, high risk – less than 1.8 mmol/L, extreme risk – less than 1 mmol/L.

Results. The reduction of LDL on therapy with alirocumab was 58%; target levels of LDL were achieved in 77.8%. The level of decrease in LDL cholesterol less than 50% was noted only in 7.4% of cases. Patients requiring a large dose of the drug were classified as very high risk, had higher cholesterol and LDL-C levels. The level of Lp(a) decrease on 29.7% by 6–12 months. No destabilization of coronary heart disease, new cases of stroke were registered.

Conclusion. The inclusion of alirocumab in the treatment regimen contributed to the stable course of atherosclerosis-associated diseases, the achievement of LDL cholesterol targets in 77.8% of patients, was not accompanied by side effects during 2.5 years therapy.

About the authors

Viktoria A. Korneva

Petrozavodsk State University

Author for correspondence.
Email: vikkorneva@mail.ru
ORCID iD: 0000-0003-2231-4695

канд. мед. наук, доц. каф. факультетской терапии, фтизиатрии, инфекционных болезней и эпидемиологии

Russian Federation, Petrozavodsk

Tatiana Y. Kuznetsova

Petrozavodsk State University

Email: vikkorneva@mail.ru
ORCID iD: 0000-0002-6654-1382

д-р мед. наук, доц., зав. каф. факультетской терапии, фтизиатрии, инфекционных болезней и эпидемиологии

Russian Federation, Petrozavodsk

Inga S. Scopets

Petrozavodsk State University

Email: vikkorneva@mail.ru
ORCID iD: 0000-0002-5157-5547

канд. мед. наук, доц. каф. госпитальной терапии

Russian Federation, Petrozavodsk

Natalia N. Vezikova

Petrozavodsk State University

Email: vikkorneva@mail.ru
ORCID iD: 0000-0002-8901-3363

д-р мед. наук, проф., зав. каф. госпитальной терапии

Russian Federation, Petrozavodsk

References

  1. Кухарчук В.В., Ежов М.В., Сергиенко И.В., и др. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Российские рекомендации, VII пересмотр. Атеросклероз и дислипидемии. 2020;1:7-40 [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 Dyslipidemia. 2020;1:7-40 (in Russian)]. doi: 10.34687/2219-8202.JAD.2020.01.0002
  2. Mach F, Baigent C, Catapano AL, et al. 2019ESC/EAS Guidelines for the management of dyslipidemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;41(1):111-88. doi: 10.1093/eurheartj/ehz455
  3. Кухарчук В.В. О новой версии рекомендаций по коррекции дислипидемии с целью профилактики атеросклероза и его осложнений. Атеросклероз и дислипидемии. 2020;1:5-6 [Kukharchuk VV. About the new version of recommendations for the correction of dyslipidemia in order to prevent atherosclerosis and its complications. Atherosclerosis and Dyslipidemia. 2020;1:5-6 (in Russian)]. doi: 10.34687/2219-8202.JAD.2020.01.0001
  4. Sabatine MS, Giugliano RP, Keech AC, et al. Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017;376:1713-22. doi: 10.1056/NEJMoa1615664
  5. Schwartz GG, Steg PG, Szarek M, et al. ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379:2097-107. doi: 10.1056/NEJMoa1801174
  6. Stock JK. Da Vinchi study: change in approach to cholesterol management will be needed to reduce the implementation gap between guidlines and clinical practice in Europe. Atherosclerosis. 2020;314:74-6. doi: 10.1016/j.atherosclerosis.2020.09.023
  7. Farnier M, Gaudet D, Valcheva V, et al. Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: pooled analysis of eight ODYSSEY Phase 3 clinical program trials. Int J Cardiol. 2016;223:750-7. doi: 10.1016/j.ijcard.2016.08.273
  8. Kastelein JJ, Hovingh GK, Langslet G, et al. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017;11:195-203. doi: 10.1016/j.jacl.2016.12.004
  9. Goldberg AC, Dunbar RL, Hemphill L, et al. A retrospective analysis of clinical use of alirocumab in lipoprotein apheresis patients. J Clin Lipidol. 2020;14:818-24. doi: 10.1016/j.jacl.2020.08.005
  10. Schwartz GG, Szarek MM, Bhatt DL, et al. Alirocumab Reduces Risk of Death after Acute Coronary Syndrome in Patients with Persistently Elevated Atherogenic Lipoproteins on Intensive Statin Treatment. Presentation at American Heart Association Scientific Session (November 11, 2018), Chicago (Illinois), USA. Available at: http://abstractsonline.com/pp8/#!/ 4682/presentation/59973. Accessed: 10.11.2018.
  11. Tunon J, Steg PJ, Bhatt DL, et al. Effect of alirocumab onmajor adverse cardiovascular events according to renal function in patients with a recent acute coronary syndrome: prespecified analysis from the ODYSSEY OUTCOMES randomized clinical trial. Eur Heart J. 2020;41:4114-23. doi: 10.1093/eurheartj/ehaa498
  12. Cholesterol Treatment Trialists’ (CTT) Collaboration. Impact of renal function on the effects of LDL cholesterol lowering with statin-based regimens: a meta-analysis of individual participant data from 28 randomised trials. Lancet Diabetes Endocrinol. 2016;4:829-39. doi: 10.1016/S2213-8587(16)30156-5
  13. Sagris D, Ntaios G, Georgiopoulos G, et al. Proprotein Convertase Subtilisin-Kexin Type 9 inhibitors and stroke prevention: A meta-analysis. Eur J Intern Med. 2021;85:130-2. doi: 10.1016/j.ejim.2020.11.021
  14. Diaz R, Li QH, Bhatt DL. Intensity of statin treatment after acute coronary syndrome, residual risk, and its modification by alirocumab: insights from the ODYSSEY OUTCOMES trial. Eur J Prev Cardiol. 2021;28:33-43. doi: 10.1177/2047487320941987
  15. Benhuria B, Ueyamaa H, Takagib H, et al. PCSK9 Inhibitors and Ezetimibe Monotherapy in Patients Not Receiving Statins: A Meta-Analysis of Randomized Trials. Curr Vasc Pharmacol. 2020;18:1-8. doi: 10.2174/1570161118666200807114559
  16. Bittner VA, Szarek M, Aylward PE, et al. Effect of Alirocumab on Lipoprotein(a) and Cardiovascular Risk After Acute Coronary Syndrome. J Am Col Cardiol. 2020;75(2):133-44. doi: 10.1016/j.jacc.2019.10.057
  17. Карпов Ю.А. Ингибиторы PCSK9 в улучшении прогноза у пациентов после острого коронарного синдрома: данные исследования ODYSSEY OUTCOMES. Рациональная фармакотерапия в кардиологии. 2018;14(6):922-34 [Karpov YuA. The Role of PCSK9 Inhibitors in the Improvement of Outcomes in Patients after Acute Coronary Syndrome: Results of ODYSSEY OUTCOMES Trial. Rational Pharmacotherapy in Cardiology. 2018;14(6):922-34 (in Russian)]. doi: 10.20996/1819-6446-2018-14-6-922-934
  18. Szarek M, Bittner VA, Aylward P. Lipoprotein(a) lowering by alirocumab reduces the total burden of cardiovascular events independent of low-density lipoprotein cholesterol lowering: ODYSSEY OUTCOMES trial. Eur Heart J. 2020(41):4245-55. doi: 10.1093/eurheartj/ehaa649
  19. Brandts J, Ray K, Hons B. Low Density Lipoprotein Cholesterol – Lowering Strategies and Population Health Time to Move to a Cumulative Exposure Model. Circulation. 2020;141:873-6. doi: 10.1161/CIRCULATIONAHA.119.043406

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