PCSK9 inhibitors (temporarily) in the broad practice of outpatient specialists: short but positive experience

Czech version

Authors: Michal Vrablík
Authors‘ workplace: Centrum preventivní kardiologie, III. interní klinika – endokrinologie a metabolismu 1. LF UK a VFN v Praze
Published in: AtheroRev 2024; 9(1): 19-25
Category: Reviews

Overview

Monoclonal antibodies against proprotein convertase subtilisin-kexin 9 are very effective hypolipidemics with a proven positive effect on the prognosis of patients. These are very well tolerated and safe medicines. As of January 1, 2024, there is a change in their prescription system, which is now available to a number of specialists and in the delegated prescription system to primary care physicians as well. This is a step in the right direction, as the previous practice of allowing prescription only to the listed centers represented an unnecessary barrier to the availability of these drugs. However, reimbursement restrictions continue to apply in terms of the definition of patient populations for whom PCSK9 inhibition brings the greatest benefit. Despite the clarification of the terms of reimbursement in their latest version, it is not easy to find your way around the individual aspects, which is why we present a commentary on the most important questions that we have encountered in the course of five years since the introduction of PCSK9 inhibitors into clinical practice in the Czech Republic.

Keywords:

alirocumab – evolocumab – PCSK9 inhibitors – reimbursement conditions

Sources

Horton JD, Cohen JC, Hobbs HH. PCSK9: a convertase that coordinates LDL catabolism. J Lipid Res 2009; 50 Suppl(Suppl): S172-S177. Dostupné z DOI: <http://dx.doi.org/10.1194/jlr.R800091-JLR200>.

Roth EM, Davidson MH. PCSK9 Inhibitors: Mechanism of Action, Efficacy, and Safety. Rev Cardiovasc Med 2018; 19(S1): S31-S46. Dostupné z DOI: <http://dx.doi.org/10.3909/ricm19S1S0002>.

Sabatine MS, Giugliano RP, Wiviott SD 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; 372(16): 1500–1509. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1500858>.

Sabatine MS, Giugliano RP, Keech AC et al. [FOURIER Steering Committee and Investigators]. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376(18): 1713–1722. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1615664>.

Robinson JG, Farnier M, Krempf M et al. [ODYSSEY LONG TERM Investigators]. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015; 372(16): 1489–1499. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1501031>.

Li H, Wei Y, Yang Z et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study. Am J Cardiovasc Drugs 2020; 20(5): 489–503. Dostupné z DOI: <http://dx.doi.org/10.1007/s40256–020–00394–1>.

O‘Donoghue ML, Giugliano RP, Wiviott SD et al. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation 2022; 146(15): 1109–1119. Dostupné z DOI: <http://dx.doi.org/10.1161/CIRCULATIONAHA.122.061620>.

Altschmiedová T, Todorovová V, Šnejdrlová M et al. PCSK9 Inhibitors in Real-world Practice: Analysis of Data from 314 Patients and 2 Years of Experience in a Center of Preventive Cardiology. Curr Atheroscler Rep 2022; 24(5): 357–363. Dostupné z DOI: <http://dx.doi.org/10.1007/s11883–022–01008–8>.

Ray KK, Bruckert E, Peronne-Filardi P et al. Long-term persistence with evolocumab treatment and sustained reductions in LDL-cholesterol levels over 30 months: Final results from the European observational HEYMANS study. Atherosclerosis 2023; 366: 14–21. Dostupné z DOI: <http://dx.doi.org/10.1016/j.atherosclerosis.2023.01.002>.

Gaudet D, López-Sendón JL, Averna M et al. [ODYSSEY APPRISE Study investigators]. Safety and efficacy of alirocumab in a real-life setting: the ODYSSEY APPRISE study. Eur J Prev Cardiol 2022; 28(17): 1864–1872. Dostupné z DOI: <http://dx.doi.org/10.1093/eurjpc/zwaa097>.

Giugliano RP, Pedersen TR, Park JG et al. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet 2017; 390(10106): 1962–1971. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140–6736(17)32290–0>.

Genest J. Transient very low LDL-C levels: a legacy effect for cardiovascular prevention? Eur Heart J 2023; 44(16): 1418–1420. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehad155>.

Gagel A, Zghyer F, Samuel C et al. What is the Optimal Low-Density Lipoprotein Cholesterol? Med Clin North Am 2022; 106(2): 285–298. Dostupné z DOI: <http://dx.doi.org/10.1016/j.mcna.2021.11.005>.

Vrablík M, Freiberger T, Bláha V et al. Souhrn konsenzu panelu expertů European Atherosclerosis Society k otázce diagnostiky a klinickému vedení nemocných s familiární hypercholesterolemií. Hypertenze a KV prevence 2015; 42): 44–48.

Memorandum k předepisování PCSK9 inhibitorů. Dostupné z WWW: <https://athero.cz/2023/06/14/memorandum-k-predepisovani-inhibitoru-pcsk9/>.

Nissen SE, Stroes E, Dent-Acosta R et al. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. JAMA 2016; 315(15): 1580–1590. Dostupné z DOI: <http://dx.doi.org/10.1001/jama.2016.3608>.

Snejdrlova M, Altschmiedova T, Vrablik M et al. Statin Intolerance in Clinical Practice. Curr Atheroscler Rep 2020; 22(7): 27. Dostupné z DOI: <http://dx.doi.org/10.1007/s11883–020–00845–9>.

Vrablík M, Blaha V, Piťha J et al. Stanovisko výboru České společnosti pro aterosklerózu k doporučením ESC/EAS pro diagnostiku a léčbu dyslipidemií z roku 2019. AtheroRev 2019; 4(3): 19–30.

Gargiulo P, Basile C, Cesaro A et al. Efficacy, safety, adherence and persistence of PCSK9 inhibitors in clinical practice: A single country, multicenter, observational study (AT-TARGET-IT). Atherosclerosis 2023; 366: 32–39. Dostupné z DOI: <http://dx.doi.org/10.1016/j.atherosclerosis.2023.01.001>.

Hope HF, Binkley GM, Fenton S et al. Systematic review of the predictors of statin adherence for the primary prevention of cardiovascular disease. PLoS One 2019; 14(1): e0201196. Dostupné z DOI: <http://dx.doi.org/10.1371/journal.pone.0201196>.

Labels

Angiology Diabetology Internal medicine Cardiology General practitioner for adults

Editorial

Consensus statement of the European Atherosclerosis Society on the 2022 lipoprotein(a) – responses to the frequently asked questions about these recommendations

First clinical experience with inclisiran in Slovakia – experience with administration, management and efficacy from one center

News from pre-specified subgroup analyzes of the CLEAR-Outcomes trial

I am 55 years old, my cholesterol is 6.5 mmol/l and I do not want statin

Professor Hana Rosolová jubilating

Semaglutide confirms its position in cardiovascular prevention in the SELECT study

Research on remarkable articles from international literature

Article was published in

Athero Review

2024 Issue 1