Abstract
Background: Bempedoic acid (BA) is considered an alternative therapy for hyperlipidemia (HLD) in statin-intolerant patients. Given the positive results from the CLEAR-OUTCOMES trial, we performed a meta-analysis pooling recently conducted randomized control trials (RCTs) to provide a comprehensive clinical evaluation of the safety and efficacy of BA. Hypothesis: Bempedoic acid therapy in HLD patients with statin intolerance may be associated with a significant reduction in LDL-C levels, and CV events. Methods: All RCTs reporting CV outcomes and/or % change in LDL-C from baseline till completion of follow-up duration in HLD patients with statin-intolerance were included in MEDLINE, Google Scholar, and Scopus databases (Inception to April 2023). The outcome measures were summary random effects risk ratio (RR) and mean differences (MD) with 95% confidence intervals. Results: Twelve RCTs were included with 18 510 patients (10,033 BA vs. 8,477 placebo). BA therapy resulted in greater significant % reduction in LDL-C levels post-treatment (mean difference from baseline: 21.73% [-26.94, -16.51], p<0.00001) with no significant impact of the male sex, age, and follow-up duration on LDL-C upon meta-regression analysis. The risk of MACE (RR, 0.86 [0.79, 0.93], p < 0.0004), coronary artery revascularization (RR, 0.81 [0.72, 0.91], p = 0.0005), and myocardial infarction (RR, 0.71 [0.51, 0.99], p= 0.04) were significantly reduced with BA ( Figure 1) . However, no significant reduction in cardiac death (RR, 1.05 [0.89, 1.24], p = 0.56) was observed. A total of 1,019 new-onset DM events (521/6027 with BA; 498/4946 with placebo) were reported, and demonstrated a non-significant lower risk of new-onset or worsening DM (RR 0.83; 95% CI [0.62, 1.13]; P = 0.24) with BA vs. placebo. Conclusion: BA was observed to be safe, efficacious, associated with improved cardiovascular outcomes, and with no effect on new-onset or worsening DM among HLD patients with statin intolerance.
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