NYMC Faculty Publications

Efficacy and Safety of Evolocumab in Statin-Treated Patients With Cardiovascular Risk Factors: A Systematic Review and Meta-Analysis

Author Type(s)

Student, Faculty

DOI

10.1080/14712598.2025.2511063

Journal Title

Expert Opinion on Biological Therapy

First Page

749

Last Page

759

Document Type

Article

Publication Date

1-1-2025

Department

Medicine

Keywords

efficacy, Evolocumab, randomized control trials, safety, statin therapy

Disciplines

Medicine and Health Sciences

Abstract

Introduction: This systematic review and meta-analysis evaluated the lipid-lowering efficacy and safety of evolocumab in statin-treated patients at high cardiovascular risk, focusing on changes in LDL-C, TG, ApoB, HDL-C, and Lp(a) after 12 weeks. Methods: A comprehensive search identified randomized controlled trials comparing evolocumab to placebo in adults on statin therapy. Studies reporting baseline and 12-week lipid and safety data were included. Risk of bias was assessed using the Cochrane tool. Random-effects models were used to calculate mean differences (MD) or odds ratios (OR) with 95% confidence intervals (CI). Results: Five trials with 4,009 participants were analyzed. Evolocumab significantly reduced LDL-C (MD: −64.67; 95% CI: −66.72 to −62.61), TG, ApoB, and Lp(a), and increased HDL-C. No significant difference was observed in total TEAEs (OR: 0.97; 95% CI: 0.84 to 1.14) or serious TEAEs (OR: 1.23; 95% CI: 0.80 to 1.89) versus placebo. Conclusions: Evolocumab offers robust lipid-lowering benefits with a safety profile comparable to placebo in statin-treated patients. Limitations include short follow-up and variable statin regimens. Further long-term studies are needed to confirm cardiovascular outcome benefits. Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024543525.

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