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De Filippo · Cardiovascular diabetology 2023 · systematic review and meta-analysis of randomized controlled trials · n=18,315 participants across 11 trials

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

Cited 41 times in the scientific literature.

Level 1 - systematic review of randomized trials

Systematic review and meta-analysis of randomized controlled trials

PubMed 38017541 · doi:10.1186/s12933-023-02022-z · record verified 2026-08-30

What was done

Systematic review and meta-analysis of randomized controlled trials identified via PubMed, Scopus, and Cochrane Library evaluating the efficacy and safety of bempedoic acid (180 mg/day) compared with placebo or no treatment in patients with hypercholesterolemia. Major adverse cardiovascular events (MACE) served as the primary clinical endpoint, LDL-cholesterol reduction as the primary laboratory endpoint, and pre-specified safety outcomes included muscle-related adverse events, new-onset diabetes, and gout.

What was found

Eleven trials comprising 18,315 patients (9,854 on bempedoic acid vs. 8,461 on control) were analyzed over a median follow-up of 87 weeks (range 15–162 weeks). Bempedoic acid significantly reduced MACE (OR 0.86, 95% CI 0.79–0.95), myocardial infarction (OR 0.76, 95% CI 0.64–0.88), and unstable angina (OR 0.69, 95% CI 0.54–0.88). At 12 weeks, bempedoic acid reduced LDL-cholesterol (mean difference -22.42%, 95% CI -24.02% to -20.82%), total cholesterol (-16.50%, 95% CI -19.21% to -13.79%), Apo-B lipoprotein (-19.55%, 95% CI -22.68% to -16.42%), and hs-CRP (-27.83%, 95% CI -31.71% to -23.96%). Bempedoic acid increased the risk of gout (OR 1.55, 95% CI 1.27–1.90). Numerical results for muscle-related events and new-onset diabetes were not reported in the abstract.

Why it matters

This meta-analysis confirms that bempedoic acid lowers lipid and inflammatory markers and translates into meaningful reductions in major cardiovascular events, though it carries an elevated risk of gout.

Limits

Trials testing dosages other than 180 mg/day were excluded. Follow-up length varied substantially across included studies (15 to 162 weeks), and the abstract did not report quantitative outcomes for muscle-related adverse events or new-onset diabetes.

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