Hussain Sohail Rangwala, Hareer Fatima, Mirha Ali, Muhammad Ashir Shafiq, Burhanuddin Sohail Rangwala, Vikash Virwani, Aashish Kumar, Syed Ali Arsal, Adarsh Raja, Sandesh Raja, Muhammad Saqlain Mustafa
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This meta-analysis aimed to evaluate the efficacy and safety of evinacumab across diverse patient populations.</p><h3>Methods</h3><p>Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria, relevant randomized controlled trials (RCTs) were systematically retrieved from multiple databases until November 24, 2023. The inclusion criteria were studies comparing evinacumab (at doses of 5 and 15 mg) to placebo, with outcomes focusing on lipid levels and adverse events. Standardized protocols were employed for data extraction and quality assessment, and statistical analysis was conducted using RevMan software.</p><h3>Results</h3><p>Four RCTs, involving 270 patients, were included in the analysis. The analysis revealed significant reductions in lipid markers, particularly with the 15-mg dose of evinacumab, including triacylglycerols (standard mean difference [SMD] = −6.09, 95% confidence interval [CI] − 14.53 to 2.36, <i>P</i> = 0.16), total cholesterol (SMD = − 6.20, 95% CI − 11.53 to − 0.88, <i>P</i> = 0.02), high-density lipoprotein cholesterol (SMD = − 0.79, 95% CI − 1.27 to − 0.31, <i>P</i> = 0.001), LDL-C (SMD = − 4.58, 95% CI − 9.13 to − 0.03, <i>P</i> = 0.05), apolipoprotein (Apo) B (SMD = − 4.01, 95% CI − 7.53 to − 0.46, <i>P</i> = 0.03), and Apo C3 (SMD = − 7.67, 95% CI − 12.94 to − 2.41, <i>P</i> = 0.004). Adverse event analysis revealed no significant association, indicating good tolerability.</p><h3>Conclusion</h3><p>High-dose evinacumab (15 mg) consistently demonstrated efficacy in reducing cholesterol and other lipid markers, with favorable tolerability. 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Standardized protocols were employed for data extraction and quality assessment, and statistical analysis was conducted using RevMan software.</p><h3>Results</h3><p>Four RCTs, involving 270 patients, were included in the analysis. The analysis revealed significant reductions in lipid markers, particularly with the 15-mg dose of evinacumab, including triacylglycerols (standard mean difference [SMD] = −6.09, 95% confidence interval [CI] − 14.53 to 2.36, <i>P</i> = 0.16), total cholesterol (SMD = − 6.20, 95% CI − 11.53 to − 0.88, <i>P</i> = 0.02), high-density lipoprotein cholesterol (SMD = − 0.79, 95% CI − 1.27 to − 0.31, <i>P</i> = 0.001), LDL-C (SMD = − 4.58, 95% CI − 9.13 to − 0.03, <i>P</i> = 0.05), apolipoprotein (Apo) B (SMD = − 4.01, 95% CI − 7.53 to − 0.46, <i>P</i> = 0.03), and Apo C3 (SMD = − 7.67, 95% CI − 12.94 to − 2.41, <i>P</i> = 0.004). 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引用次数: 0
摘要
背景：心血管疾病仍然是全球关注的重大健康问题，而低密度脂蛋白胆固醇（LDL-C）水平过高会增加患病风险。家族性高胆固醇血症（FH）使其治疗更加复杂，需要额外的降脂疗法。Evinacumab是一种血管生成素样蛋白3单克隆抗体，可有效降低低密度脂蛋白胆固醇和甘油三酯水平，是一种潜在的治疗方法，尤其适用于FH患者。这项荟萃分析旨在评估依维莫司在不同患者群体中的疗效和安全性：按照系统综述和荟萃分析首选报告项目（PRISMA）标准，从多个数据库中系统检索了相关的随机对照试验（RCT），直至 2023 年 11 月 24 日。纳入标准是将伊维那单抗（剂量为 5 毫克和 15 毫克）与安慰剂进行比较的研究，结果侧重于血脂水平和不良事件。采用标准化方案进行数据提取和质量评估，并使用RevMan软件进行统计分析：分析共纳入了四项 RCT 研究，涉及 270 名患者。分析显示，血脂指标明显降低，尤其是 15 毫克剂量的依维那单抗，包括三酰甘油（标准平均差 [SMD] = -6.09，95% 置信区间 [CI] - 14.53 至 2.36，P = 0.16）、总胆固醇（SMD = -6.20，95% CI - 11.53 至 - 0.88, P = 0.02）、高密度脂蛋白胆固醇（SMD = - 0.79, 95% CI - 1.27 to - 0.31, P = 0.001）、低密度脂蛋白胆固醇（SMD = - 4.58, 95% CI - 9.13 to - 0.03，P = 0.05）、载脂蛋白（载脂蛋白）B（SMD = - 4.01，95% CI - 7.53 至 - 0.46，P = 0.03）和载脂蛋白 C3（SMD = - 7.67，95% CI - 12.94 至 - 2.41，P = 0.004）。不良事件分析显示无明显关联，表明耐受性良好：结论：大剂量依维那单抗（15 毫克）在降低胆固醇和其他血脂指标方面具有持续疗效，且耐受性良好。需要进一步研究以全面评估其安全性和临床有效性，同时强调需要更多数据来支持其在控制心血管疾病方面的应用。
Evaluating the Effectiveness and Safety of Evinacumab in Treating Hypercholesterolemia and Hypertriglyceridemia: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Background
Cardiovascular disease remains a significant global health concern, with high low-density lipoprotein cholesterol (LDL-C) levels contributing to an increased risk. Familial hypercholesterolemia (FH) further complicates its management, necessitating additional lipid-lowering therapies. Evinacumab, an angiopoietin-like protein 3 monoclonal antibody, has emerged as a potential treatment, particularly for patients with FH, by effectively reducing LDL-C and triglyceride levels. This meta-analysis aimed to evaluate the efficacy and safety of evinacumab across diverse patient populations.
Methods
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria, relevant randomized controlled trials (RCTs) were systematically retrieved from multiple databases until November 24, 2023. The inclusion criteria were studies comparing evinacumab (at doses of 5 and 15 mg) to placebo, with outcomes focusing on lipid levels and adverse events. Standardized protocols were employed for data extraction and quality assessment, and statistical analysis was conducted using RevMan software.
Results
Four RCTs, involving 270 patients, were included in the analysis. The analysis revealed significant reductions in lipid markers, particularly with the 15-mg dose of evinacumab, including triacylglycerols (standard mean difference [SMD] = −6.09, 95% confidence interval [CI] − 14.53 to 2.36, P = 0.16), total cholesterol (SMD = − 6.20, 95% CI − 11.53 to − 0.88, P = 0.02), high-density lipoprotein cholesterol (SMD = − 0.79, 95% CI − 1.27 to − 0.31, P = 0.001), LDL-C (SMD = − 4.58, 95% CI − 9.13 to − 0.03, P = 0.05), apolipoprotein (Apo) B (SMD = − 4.01, 95% CI − 7.53 to − 0.46, P = 0.03), and Apo C3 (SMD = − 7.67, 95% CI − 12.94 to − 2.41, P = 0.004). Adverse event analysis revealed no significant association, indicating good tolerability.
Conclusion
High-dose evinacumab (15 mg) consistently demonstrated efficacy in reducing cholesterol and other lipid markers, with favorable tolerability. Further research is warranted to comprehensively assess its safety and clinical effectiveness, emphasizing the need for additional data to support its use in managing cardiovascular disease.
期刊介绍：
Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents.
Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations.
The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
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