Summary

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• Nexlizet (bempedoic acid and ezetimibe) is indicated as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). It is also indicated to reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy, with established cardiovascular disease (CVD), or at high risk for a CVD event but without established CVD.
• This summary is based on the review of seven systematic review(s)/meta-analysis(es). ^[1-7]
• Major Adverse Cardiovascular Events (MACE): Bempedoic Acid (BA) was associated with a reduced risk of 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) over a median follow-up of 87 weeks.
• Lipid Profile: BA significantly reduced LDL cholesterol (mean difference [MD] -22.42%, 95% CI -24.02% to -20.82%), total cholesterol (MD -16.50%, 95% CI -19.21% to -13.79%), Apo-B lipoprotein (MD -19.55%, 95% CI -22.68% to -16.42%), and high-sensitivity CRP (MD -27.83%, 95% CI -31.71% to -23.96%) at 12 weeks. Combined with ezetimibe, BA further reduced LDL cholesterol (MD -29.14%, 95% CI -39.52% to -18.76%), total cholesterol (MD -15.78%, 95% CI -20.84% to -10.72%), non-HDL cholesterol (MD -18.36%, 95% CI -24.60% to -12.12%), and hsCRP levels (MD -30.48%, 95% CI -44.69% to -16.28%).
• Comparison to Other Drugs: Evolocumab and alirocumab were more efficacious in reducing LDL-C levels compared to BA, with inclisiran, evolocumab, and alirocumab showing superior efficacy over BA and ezetimibe in LDL-C reduction.
• Bempedoic Acid (BA) was associated with a higher risk of gout (OR 1.55, 95% CI 1.27-1.90), elevated serum uric acid levels (OR 3.55, 95% CI 1.03-12.27), elevated liver enzymes (OR 4.28, 95% CI 1.34-13.71), and elevated creatine kinase (OR 3.79, 95% CI 1.06-13.51) compared to placebo. Additionally, BA showed a higher rate of treatment discontinuation due to adverse effects, particularly related to gout flare and increased uric acid levels.
• The combination of BA and ezetimibe showed a non-significant increased risk of drug-related adverse events (RR 1.61, 95% CI 0.86-2.35) and overall adverse events (RR 1.16, 95% CI 0.97-1.35) compared to controls.
• There is no population type or subgroup information available in the reviewed studies.