Clinical efficacy and safety outcomes of bempedoic acid: An updated systematic review and meta-analysis after CLEAR Outcomes trial

Abstract

Purpose

Statins are the cornerstone therapy for primary or secondary prevention of atherosclerotic cardiovascular disease (ASCVD). However, a significant portion of patients are intolerant to statin or show inadequate lipid-lowering. Bempedoic acid (BA) has been shown to decrease low-density lipoprotein cholesterol (LDL-C) in clinical trials. However, the evidence on the effect of BA on clinical cardiovascular outcomes was limited until the CLEAR Outcomes trial. Thus, to fully appraise the available data, we performed this meta-analysis.

Methods

PubMed, Pubmed Central, Embase, and Scopus databases were searched for relevant articles published before May 1, 2023. Pertinent data from the included studies were extracted and analyzed using RevMan v5.4.

Results

Out of 2209 studies evaluated, five randomized control trials with 17,384 patients with established ASCVD or at high risk of ASCVD were included for analysis. The BA therapy reduced major adverse cardiovascular events (OR 0.85, CI 0.77-0.93; <0.0001), non-fatal myocardial infarction (OR 0.75, 95 % CI 0.64-0.88; p <0.0001), hospitalization for unstable angina (OR 0.69, CI 0.53-0.89; p = 0.005) and coronary revascularization (OR 0.80, CI 0.61-0.91; <0.0001) significantly without decreasing the risk of all-cause death (OR 1.19, CI 0.73-1.94; p = 0.49), cardiovascular death (OR 1.04, CI 0.87-1.25; p = 0.68) and non-fatal stroke (OR 0.84, CI 0.66-1.06; p = 0.15).

Conclusion

Based on our analysis the bempedoic acid addition to therapy reduced cardiovascular events in selective patients who are either intolerant to statins or do not achieve recommended LDL-C levels despite being on a maximum dose of statins and/or ezetimibe.