Clinical Efficacy and Safety of Bempedoic Acid in High Cardiovascular Risk Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Bempedoic acid (BA) is the new addition to lipid-lowering medications. This systematic review and meta-analysis of randomized controlled trials (RCTs) assess the clinical efficacy and safety of BA in high cardiovascular (CV) risk patients along with its effects on low-density lipoprotein cholesterol (LDL-C) and total cholesterol. PubMed, Google Scholar, Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov were searched for RCTs comparing BA with placebo, reporting CV outcomes. Seven RCTs with a total of 17,816 patients were selected for the analysis. Results showed that BA significantly reduced the risk of MACE (RR 0.87, 95% CI 0.80-0.94; P = 0.007), nonfatal myocardial infarction (RR 0.73; 95% CI 0.62-0.85; P < 0.0001), hospitalization for unstable angina (RR 0.69; 95%CI 0.54-0.88; P = 0.003), coronary and noncoronary revascularization (RR 0.82; 95%CI 0.73-0.92; P = 0.0007) and (RR 0.41; 95%CI 0.18-0.96; P = 0.04), respectively. However, BA increased the risk of gout (RR 1.55; 95% CI 1.26-1.90; P < 0.0001), hyperuricemia (RR 1.94; 95% CI 1.73-2.18; P < 0.00001) and worsening renal function (RR 1.34; 95%CI 1.21-1.48; P < 0.00001). BA also reduced LDL-C (MD -22.38%; 95% CI -25.94 to - 18.82; P < 0.00001) and total cholesterol (MD -13.86%; 95% CI -15.82 to -11.91; P < 0.0000) compared with placebo. Bempedoic acid is an addition to the arsenal of lipid-lowering drugs used in patients that are statin intolerant or need additional lipid-lowering therapy.