News from pre-specified subgroup analyzes of the CLEAR-Outcomes trial
Authors:
Ubomíra Fábryová 1,2,3,4
Authors‘ workplace:
MetabolKLINIK s. r. o., Ambulancia pre diabetológiu, poruchy látkovej premeny a výživy, MED PED centrum, Bratislava
1; Ústav výživy FOaZOŠ, Slovenská zdravotnícka univerzita v Bratislave
2; Biomedicínske centrum Slovenskej Akadémie Vied, Bratislava
3; Vysoká škola zdravotníctva a sociálnej práce sv. Alžbety, Inštitút prevencie a intervencie, Bratislava
4
Published in:
AtheroRev 2024; 9(1): 35-40
Category:
Reviews
Overview
The number of patients using hypolipidemic treatment is increasing from year to year. On a global scale, the most frequently prescribed hypolipidemic drugs are statins, which have become first-line drugs as well as the cornerstone of combined hypolipidemic therapy. Suboptimal adherence to hypolipidemic treatment is associated with suboptimal control of the lipid spectrum, with an increase in cardiovascular disease and death, as well as with increasing costs for the management of dyslipidemia treatment and associated diseases and complications. The most common cause of non-adherence or interruption of hypolipidemic treatment is muscle symptomatology with subsequent statin intolerance, for which we have defined precise procedures. The possibility of continuing the treatment is the use of combined hypolipidemic treatment with the use of ezetimibe and/or bempedoic acid, or their fixed combinations. Recently published pre-specified analyzes of the CLEAR-Outcomes trial proved that bempedoic acid is effective in reducing further (subsequent) cardiovascular events, is effective in patients with various degrees of impaired glucose tolerance, without increasing the risk of developing new-onset diabetes mellitus and can be safely and effectively used in combination with ezetimibe in individuals with statin intolerance.
Keywords:
bempedoic acid – statin intolerance – ezetimibe – CLEAR-Outcomes trial – pre-specified subgroup analysis
Sources
Mach F, Baigent C, Catapano AL 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): 111–188. Dostupné z DOI: <https://doi.org/10.1093/eurheartj/ehz455>. Erratum et Corrigendum: 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J 2020; 41(44): 4255. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehz826>.
Visseren FLJ, Mach F, Smulders YM et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2021; 42(34): 3227–3337. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehab484>. Erratum: Eur Heart J 2022; 43(42): 4468. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehac458>.
Marx N, Federici M, Schütt K et al. [ESC Scientific Document Group]. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J 2023; 44(39): 4043–4140. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehad192>. Erratum: Eur Heart J 2023; 44(48): 5060. Dostupné u DOI: <http://dx.doi.org/10.1093/eurheartj/ehad774>. Erratum: Eur Heart J 2024; 45(7): 518. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehad857>.
Nielsen SF, Nordestgaard BG. Negative statin-related news stories decrease statin persistence and increase myocardial infarction and cardiovascular mortality: a nationwide prospective cohort study. Eur Heart J 2016 Mar; 37(11): 908–916. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehv641>.
Jacobson TA, Cheeley MK, Jones PH et al. The statin adverse treatment experience survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol 2019; 13(3): 415–424. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jacl.2019.04.011>.
Stroes ES, Thompson PD, Corsini A et al. Statin-associated muscle symptoms: impact on statin therapy – European Atherosclerosis Society consensus panel statement on assessment, aetiology and management. Eur Heart J 2015; 36(17): 1012–1022. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehv043>.
Li JJ, Liu HH, Wu NQ et al. Statin intolerance: an updated, narrative review mainly focusing on muscle adverse effects. Expert Opin Drug Metab Toxicol 2020; 16(9): 837–851. Dostupné z DOI: <https://doi.org/10.1080/17425255.2020.1802426>.
Fábryová Ľ. Manažment pacienta so statínovou intoleranciou v ambulancii všeobecného lekára. Všeobec Lék 2023; 2(2): 73–78.
Gažová A. Kyselina bempedoová – liečivo ovplyvňujúce dyslipidémiu zatiaľ nepoužívaným mechanizmom účinku. Nové Lieky 2023; (Suppl 2): 9–12.
Soška V, Kyselák O. Kyselina bempedová – nový lék ke snižování hladiny LDL-cholesterolu. AtheroRev 2022; 7(3): 147–151.
Pinkosky SL, Newton RS, Day EA et al. Liver specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun 2016; 28(7):13457. Dostupné z DOI: <http://dx.doi.org/10.1038/ncomms13457>.
Ballantyne CM, Laufs U, Ray KK et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol 2020; 27(6): 593–603. Dostupné z DOI: <http://dx.doi.org/10.1177/2047487319864671>.
Ballantyne CM, Bays H, Catapano AL et al. Role of Bempedoic Acid in Clinical Practice. Cardiovasc Drugs Ther 2021; 35(4): 853–864. Dostupné z DOI: <http://dx.doi.org/10.1007/s10557–021–07147–5>. Erratum: Cardiovasc Drugs Ther 2021; 35(4): 865. Dostupné z DOI: <http://dx.doi.org/10.1007/s10557–021–07188-w>.
Nicholls S, Lincoff AM, Bays HE et al. Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance. Am Heart J 2021; 235: 104–112. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ahj.2020.10.060>.
Nissen SE, Lincoff AM, Brennan D et al. CLEAR Outcomes Investigators. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med 2023; 388(15): 1353–1364. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa2215024>.
Nissen SE, Menon V, Nicholls SJ et al. Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients. JAMA 2023; 330(2): 131–140. Dostupné z DOI: <http://dx.doi.org/10.1001/jama.2023.9696>.
Nicholls SJ. Impact of Bempedoic Acid on Total Cardiovascular Events: Pre-Specified Analysis of the CLEAR Outcomes Study. Presented on 26 August as a late-breaker oral presentation at ESC 2023, Amsterdam, Netherlands.
Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375(9716): 735–742. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140–6736(09)61965–6>.
Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA 2011; 305(24): 2556–2564. Dostupné z DOI: <http://dx.doi.org/10.1001/jama.2011.860>.
Ridker PM, Lei L, Louie MJ et al. [CLEAR Outcomes Investigators]. Inflammation and Cholesterol as Predictors of Cardiovascular Events Among 13 970 Contemporary High-Risk Patients With Statin Intolerance. Circulation 2024; 149(1): 28–35. Dostupné z DOI: <http://dx.doi.org/10.1161/CIRCULATIONAHA.123.066213>.
Ray KK, Nicholls SJ, Li N et al. CLEAR OUTCOMES Committees and Investigators. Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial. Lancet Diabetes Endocrinol 2024; 12(1): 19–28. Dostupné z DOI: <http://dx.doi.org/10.1016/S2213–8587(23)00316–9>.
Laffin LJ, Brennan D, Mason D et al. Background Ezetimibe Use Among Participants in the CLEAR Outcomes Trial. Poster ID: 316 presented at the American Society for Preventive Cardiology (ASPC) Congress – 21st-23rd July 2023.
Labels
Angiology Diabetology Internal medicine Cardiology General practitioner for adultsArticle was published in
Athero Review
2024 Issue 1
Most read in this issue
- I am 55 years old, my cholesterol is 6.5 mmol/l and I do not want statin
- Semaglutide confirms its position in cardiovascular prevention in the SELECT study
- 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