[Efficacy and safety of bempedoic acid in the prevention of cardiovascular events: results of the CLEAR Outcomes study and subgroup analyses].

Abstract

Bempedoic acid is a lipid-lowering drug recently introduced into clinical practice. The CLEAR Outcomes randomized controlled clinical trial has confirmed the efficacy of bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) levels and has shown that this reduction translates into a significant decrease in major adverse cardiovascular events (MACE). The clinical benefits were consistent with the benefits obtained with other lipid-lowering drugs that have the same efficacy in reducing LDL-C levels. Furthermore, the CLEAR Outcomes trial confirmed the safety of bempedoic acid. This study reported the same frequency of adverse events as observed in previous phase 3 trials. Pre-specified and post-hoc analyses of the CLEAR Outcomes trial showed that treatment with bempedoic acid confers a clinical benefit both in primary prevention and in patients with recurrent events, independent of gender and comorbidities such as diabetes, obesity and metabolic syndrome, and confirmed a potential additive benefit due to the favorable effects on the glycemic profile and high-sensitivity C-reactive protein. In patients with peripheral artery disease, bempedoic acid reduces both MACE and major adverse limb events. Based on the available evidence, the European Medicines Agency has updated the summary of product characteristics to include cardiovascular disease as a therapeutic indication in addition to hypercholesterolemia. Bempedoic acid is now approved in adults with established atherosclerotic cardiovascular disease or at high risk of a first cardiovascular event, to reduce cardiovascular risk by lowering LDL-C levels, in patients treated with the maximum tolerated statin dose (with or without ezetimibe), or in statin-intolerant patients who are not adequately controlled with ezetimibe alone.