EXPERIENCE WITH THE USE OF EVOLOCUMAB THERAPY IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA (IN KARELIA REPUBLIC)
https://doi.org/10.38109/2225-1685-2020-2-42-47
Abstract
Aim: to evaluate the efficacy and safety of the use of evolocumab in patients with familial hypercholesterolemia (FH).
Materials and methods: Fifteen patients with a definite FH were treated with PCSK9 inhibitors, in 11 patients with a history of CAD. Eight patients (53.3%) received evolocumab (Repata) subcutaneously 140 mg once every 2 weeks, their average age was 51.4±2.3 years, 6 men. Lipid spectrum, ALT, AST, creatinine, glucose, Lp (a) were evaluated after 3, 6, 12 and 18 months, the ECG and the clinical picture were monitored. Evolocumab was prescribed in connection with the failure to achieve the target LDL. Before the start of therapy, 7 patients received statins, 5 statins with ezetemib, 1 patient did not receive lipid-lowering therapy due to intolerance. The target LDL levels were considered: for very high risk patients less than 1.4 mmol/L, high risk – less than 1.8 mmol/L. Statistical processing of the material was performed using STATISTICA10.0.
Results: On the background of evolocumab therapy, the average level of LDL after 3 months of therapy decreased by 56.4% (from 3.9±0.3 to 1.71±0.2 mmol/L), the effect persisted after a year. All patients did not stop the therapy; there were no side effects, including local ones. Target LDL was achieved in 62.5% of patients, the average LDL level after 3 months of therapy decreased by 56.4% in patients from the initial, including the case of monotherapy with evolocumab. The Lp (a) level during therapy decreased by 30%.
Conclusions: Evolocumab allows to increase the achievement of the target LDL level on 40% in FH patients; target LDL level was achieved in 62.5%. LDL decreased after 3 months by 56.4%, remaining stable with prolonged therapy. The decrease in Lp(a) reached 30%. Evolocumab therapy was characterized by high adherence and the absence of side effects.
About the Authors
V. A. Korneva
Petrosavodsk State University
Russian Federation
Russian Federation
Viktoriya A. Korneva, MD, PhD associated professor of the department of Faculty Therapy, Phthisiology, Infectious Diseases and Epidemiology
185000, Petrozavodsk, st. North, 4-26
T. Yu. Kuznetsova
Petrosavodsk State University
Russian Federation
Tatiana Yu. Kuznetsova, MD, PhD, associated professor, the head of the department of Faculty Therapy, Phthisiology, Infectious Diseases and Epidemiology
Russian Federation
Tatiana Yu. Kuznetsova, MD, PhD, associated professor, the head of the department of Faculty Therapy, Phthisiology, Infectious Diseases and Epidemiology
N. N. Natal’ya N. Vezikova
Petrosavodsk State University
Russian Federation
Natal’ya N. Vezikova, MD, PhD, professor, the head of the department of Hospital Therapy
Russian Federation
Natal’ya N. Vezikova, MD, PhD, professor, the head of the department of Hospital Therapy
References
1. Nanchen D., Gencer B., Auer R. al. Prevalence and management of familial hypercholesterolaemia in patients with acute coronary syndromes. Eur Heart J. 2015;36(36):2438-45. DOI:10.1093/eurheartj/ehv289.
2. Akioyamen LE, Genest J, Shan SD, Reel RL, Albaum JM, Chu A, Tu JV. Estimating the prevalence of heterozygous familial hypercholesterolaemia: a systematic review and meta-analysis. BMJ Open. 2017;7:e016461. https://doi.org/10.1136/bmjopen-2017–016461.
3. Ezhov M.V., Lazareva N.V., Sagajdak O. V.et al. The frequency of lipid metabolism disorders and the use of statins in acute coronary syndrome (according to the Federal Register of Acute Coronary Syndrome). Ateroskleroz i Dislipidemii. 2018;1:47-57 (in Russ.).
4. Mach F., Baigent C., Catapano A.L., Koskinas K.C., Casula M., Badimon L.et al. ESC Scientific Document Group, 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): 111–188, https://doi.org/10.1093/eurheartj/ehz455.
5. Ference B.A., Ginsberg H.N., Graham I. et al. Low density lipoproteins cause atherosclerotic cardiovascular disease. 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.
6. Ballantyne C.M., Abate N., Yuan Z. et al. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: The Vytorin Versus Atorvastatin (VYVA) Study. Am. Heart J. 2005.Vol. 149, N 3. P. 464–473. DOI: 10.1016/j.ahj.2004.11.023.
7. Kotseva K., Wood D., De Bacquer D. et al. EUROASPIRE IV: A European Society of Cardiology survey on the lifestyle, risk factor and therapeutic management of coronary patients from 24 European countries. Eur. J. Prev. Cardiol. 2016. Vol. 23, N 6. P. 636–648. DOI: 10.1177/2047487315569401
8. Korneva V.A., Kuznetsova T.Yu. Lipid-lowering therapy in patients with familial hypercholesterolemia in the real-life clinical practice. Clin. Pharmacol. Ther. 2018; 27 (4): 24-28. (in Russ.)
9. Korneva V.A., Kuznetsova T.Yu., Tihova G.P. Lipid Lowering Therapy with Statins in Patients with Heterozygous Familial Hypercholesterolemia. Kardiologiia. 2019;59(3):27–35. (in Russ.). doi.org/10.18087/cardio.2019.3.10238
10. Bliznyuk S. A., Rozhkova T. A., Ezhov M. V. et al. Lipid-lowering Therapy and Predictors of сcardiovascular Outcomes in Patients with heterozygous Familial Hypercholesterolemia. Ateroskleroz i dislipidemii 2019;4(37):36-45 (in Russ.). DOI: 10.34687/2219-8202
11. Zhang H., Plutzky J., Skentzos S. et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013. Vol.158. P.526-34. doi:10.7326/0003-4819-158-7-201304020-00004
12. Ganga H.V., Slim H.B., Thompson P.D. A systematic review of statininduced muscle problems in clinical trials. Am Heart J. 2014. Vol.168. P.6-15. doi:10.1016/j.ahj.2014.03.019
13. Serban M.C., Colantonio L.D., Manthripragada A.D.,Monda K.L.,Bittner V.A., Banach M. et al. Statin Intolerance and Risk of Coronary Heart Events and All-Cause Mortality Following Myocardial Infarction. J. Am. Coll Cardiol. 2017. Vol. 69(11). P.1386-1395. DOI:10.1016/j.jacc.2016.12.036
14. Kotseva K. on behalf of EUROASPIRE investigators. Implementation of cardiovascular disease prevention in daily practice – Insights from EUROASPIRE V. Reaching lipid targets in coronary patents – Temporal trends and state of the art. Presented at ESC 2018, Munich. [cited by Nov 11, 2018]. https://esc365.escardio.org/Congress/ESC-Congress-2018/ Implementation-of-cardiovascular disease-prevention-in-daily-practiceInsig/17
15. Raal F.J., Panz V.R., Immelman A., Pilcher G.J. Elevated PCSK9 levels in untreated patients with heterozygous or homozygous familial hypercholesterolemia and the response to high-dose statin therapy. J. Am. Heart Assoc. 2013. V. 2. P. e000028. DOI: 10.1161/JAHA.112.000028
16. Karpov Y. A., Talitskaya, A. K. Evalocumab is the representative of a new class of lipid-lowering drugs. Atmosfera. Novosti kardiologii 2015;4:21-28 (in Russ.)
17. Navarese E.P., Kolodziejczak M., Schulze V. et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia:a systematic review and meta-analysis. Ann. Intern. Med. 2015. Vol. 163. P. 40–51. DOI: 10.7326/M14-2957.
18. Raal F.J., Stein E.A., Dufour R. et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015. Vol. 385, N 9965. P. 331–340. DOI: 10.1016/S0140-6736(14)61399-4/
19. Robinson J.G., Nedergaard B.S., Rogers W.J. et al. Effect of evolocumab or ezetimibe added to moderate- or highintensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014. Vol. 18. P. 1870–1882. DOI: 10.1001/jama.2014.4030.
20. Boronat M., Saavedra P., Pérez-Mart n N. et al. High levels of lipoprotein(a) are associated with a lower prevalence of diabetes with advancing age: results of a cross-sectional epidemiological survey in Gran Canaria, Spain. Cardiovasc. Diabetol. 2012. Vol. 11. P. 81. https://doi.org/10.1186/1475-2840-11-81
21. Konovalov G. A.,Bazhan S. S. Evolocumab: innovative opportunities for LDL–C and LP (a) lowering and cardiovascular risk management/Kardiologiya: novosti, mneniya, obuchenie 2017;.2: 45–56 (in Russ.)
22. Vanuzzo D. The epidemiological concept of residual risk. Intern. Emerg. Med. 2011. Vol. 6, suppl. 1. P. 45–51. DOI: 10.1007/s11739-011-0669-5.
23. Sabatine S.M., Giugliano R.P., Wiviott S.D. et al. Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N. Engl. J. Med. 2015. Vol. 372. P. 1500–1509. DOI: 10.1056/NEJMoa1500858.
24. Nicholls S.J., Puri R., Anderson T. et al. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial // JAMA. 2016. Vol. 316, N 22. P. 2373–2384. DOI : 10.1001/jama.2016.16951.
25. Koren M.J., Giugliano R.P., Raal F.J. et al. Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial Circulation. 2014. Vol. 129 (2). P. 234–243. DOI: 10.1161/CIRCULATIONAHA.113.007012
26. Koren M.J., Sabatine M.S., Giugliano R.P. et al. Long-term Low-Density Lipoprotein Cholesterol-Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia: Results Up to 4 Years from the Open-Label OSLER-1 Extension Study. JAMA Cardiol. 2017.2(6). P.598-607. DOI: 10.1001/jamacardio.2017.0747.
Review
For citations:
Korneva V.A., Kuznetsova T.Yu., Natal’ya N. Vezikova N.N. EXPERIENCE WITH THE USE OF EVOLOCUMAB THERAPY IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA (IN KARELIA REPUBLIC). Eurasian heart journal. 2020;(2):42-47. (In Russ.) https://doi.org/10.38109/2225-1685-2020-2-42-47
Views:
3060
Email this article 
