evolocumab在他汀类药物治疗的心血管危险因素患者中的疗效和安全性：一项系统回顾和荟萃分析

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2025-05-24 DOI:10.1080/14712598.2025.2511063

Mayank Jha, Siddharth Pravin Agrawal, Darshilkumar Maheta, Priyadarshini Bhattacharjee, Hritvik Jain, Jerome Zacks, William H Frishman, Wilbert S Aronow

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引用次数: 0

摘要

本系统综述和荟萃分析评估了evolocumab在他汀类药物治疗的心血管高危患者中的降脂疗效和安全性，重点关注12周后LDL-C、TG、ApoB、HDL-C和Lp(a)的变化。方法：一项综合搜索确定了随机对照试验，比较evolocumab和安慰剂在成人他汀类药物治疗中。研究报告了基线和12周的血脂和安全性数据。使用Cochrane工具评估偏倚风险。随机效应模型用于计算95%置信区间（CI）的平均差异（MD）或比值比（or）。结果：分析了5项试验，共4,009名受试者。Evolocumab显著降低LDL-C (MD: -64.67；95% CI: -66.72 ~ -62.61)、TG、ApoB和Lp(a)以及HDL-C升高。两组总teae差异无统计学意义(OR: 0.97；95% CI: 0.84 ~ 1.14)或严重teae (or: 1.23；95% CI: 0.80 - 1.89)。结论：Evolocumab在他汀类药物治疗的患者中具有强大的降脂效果，其安全性与安慰剂相当。局限性包括随访时间短和他汀类药物治疗方案多变。需要进一步的长期研究来证实心血管结果的益处。协议注册：www.crd.york.ac.uk/prospero标识为CRD42024543525。

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Efficacy and safety of evolocumab in statin-treated patients with cardiovascular risk factors: a systematic review and meta-analysis.

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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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.