Efficacy and Safety of Bempedoic Acid to Prevent Cardiovascular Events in Individuals at Risk of Cardiovascular Diseases: A Meta-Analysis of Randomized-Control Trials

Abstract

The purpose of this study was to evaluate the effectiveness and safety of bempedoic acid in preventing cardiovascular events among high-risk patients. We conducted a meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Two independent researchers carried out online database searches on Medline, the Cochrane Library of Clinical Trials, and EMBASE until April 15, 2023, using search terms such as "bempedoic acid," "cardiovascular outcomes," and "randomized controlled trial." We also utilized medical subject heading (MeSH) terms and Boolean algebra operators to refine our search. We included articles that compared cardiovascular outcomes between patients receiving bempedoic acid and those receiving a placebo. The primary outcome assessed was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, nonfatal stroke, hospitalization for unstable angina, and coronary revascularization. The meta-analysis included three randomized controlled trials with a total of 16,978 patients. The use of bempedoic acid was associated with a significant reduction in major adverse cardiovascular events. Individual analyses reported a low risk of myocardial infarction, coronary revascularization, and hospitalization due to unstable angina in patients receiving bempedoic acid. Furthermore, our meta-analysis found that bempedoic acid is a safe treatment option, as there was no significant difference between the bempedoic acid and placebo groups in terms of adverse events and serious adverse events. Our findings support the use of bempedoic acid as a promising treatment option for high-risk cardiovascular patients. However, since our meta-analysis included a limited number of studies with short follow-up periods, larger studies are necessary to provide more definitive evidence.

Safety and efficacy of bempedoic acid: a systematic review and meta-analysis of randomised controlled trials

“…To the best of our knowledge this is the largest meta-analysis investigating the clinical properties of BA and including a sample size that is sufficiently powered to assess the efficacy of the drug on hard cardiovascular endpoints following the inclusion of the CLEAR outcome trial [ 17 ]. Our findings indeed confirm and extend those of previously published metanalyses focusing on cardiovascular events, where BA proved to be associated with a significant reduction of MACE, myocardial infarction, and myocardial revascularizations, with no substantial signs of heterogeneity or harm [ 27 – 29 ]. While the efficacy of BA in improving the lipidic profile has been previously confirmed both in patients with and without metabolic syndrome [ 30 ], the current analysis also allows to assess with greater precision the incremental benefit of the drug across different statin and non-statin background LLT and according to background medical history (either in patients with established ASCD or not).…”

Bempedoic Acid: How Will It Shape the Future Lipid-Lowering Landscape? Mode of Action, Evidence, and Clinical Use

“…A meta-analysis published in May 2023 [26], covering data from 16,978 patients, confirmed the safety data from individual trials and underlined the efficacy of BA in reducing a 5-point MACE (cardiovascular death, myocardial infarction, nonfatal stroke, hospitalization due to unstable angina, and coronary revascularization). Here, it should be mentioned that a 5-point MACE endpoint is not uniformally accepted because only the first three event types are considered hard endpoints that are not influenced by physician decision [12].…”

Dyslipidaemia in elderly and stroke patients

“…In that study the individual analyses showed a low risk of MI, coronary revascularization, and hospitalization due to unstable angina but without any effect on stroke. 38 Thus, in future more number of studies are much awaited to validate its optimal benefit in patients with outcomes of stroke.…”