ROLE OF BEMPEDOIC ACID IN PREVENTION OF CARDIOVASCULAR EVENTS

In the editorial of the March issue of the New England Journal of Medicine (NEJM), it is clearly stated that compelling results from the randomized, placebo-controlled CLEAR (Cholesterol Lowering via Bempedoic Acid and ACL-Inhibiting Regimen) Outcomes study could and should increase the use of bempedoic acid in patients with established atherosclerosis who have a high cardiovascular (CV) risk and cannot or do not want to take statins due to side effects. This clinical trial included a composite primary endpoint (CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization) in patients on bempedoic acid 180 mg (n=6992) reduced by 13% compared to patients on placebo (n=6978). The primary outcome occurred in 11.7% of patients on bempedoic acid compared to 13.3% on placebo; the absolute risk reduction was 1.6% (risk ratio 0.87; 95% confidence interval, 0.79 to 0.96; P=0.004). The participants were followed for 6 months. Bempedoic acid did not have a significant effect on CV death or all-cause mortality. The editor emphasizes that bempedoic acid cannot be considered an alternative to statins. High-quality evidence exists for the benefits of statins, and clinicians should continue to prescribe them at the maximum tolerable doses for appropriate patients. Although bempedoic acid also lowers LDL cholesterol levels in patients taking statins, the clinical benefit of simultaneous use is not known/confirmed. The editor also highlights that two observations from the CLEAR Outcomes study should be further investigated - the suggestion that bempedoic acid has a greater effect in primary prevention and the finding that there was no effect of the drug on mortality. Is this due to effective concomitant therapy, a short follow-up period, or an actual lack of the drug's effect on mortality? With this report, bempedoic acid is added to the list of alternatives to statins for primary and secondary prevention in patients with a high CV risk. The study has provided numerous data and clarified the effectiveness and safety of the drug. The drug is approved in the European Union under the name Nilemdo and is intended for standalone use as well as for use with statins and other lipid-lowering medications. It is not on the list of drugs covered by the Croatian Health Insurance Fund (HZZO).

LiteraturE:

1. Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial. JAMA.

2019;322(18):1780–1788. doi:10.1001/jama.2019.16585

2. Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-intolerant patients. N Engl J Med. DOI: 10.1056/NEJMoa2215024