Ghasempour Ghasem, Zamani-Garmsiri Fahimeh, Shaikhnia Farhad, Soleimani Ali Akbar, Hosseini Fard Syed Reza, Leila Janani, Teimuri Shohreh, Parvaz Najmeh, Mohammadi Payam, Najafi Mohammad
Davee Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago Illnosis, USA.
Department of Clinical Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Curr Med Chem. 2024;31(2):223-241. doi: 10.2174/0929867330666230228120601.
Familial hypercholesterolemia (FH) is a prevalent and potentially fatal illness that causes a substantial elevation in low-density lipoprotein cholesterol (LDL-C).
The aim of this study was to investigate the effects of monoclonal antibodies alirocumab and evolocumab on LDL-C and other lipid parameters, as well as their safety in familial hypercholesterolemia patients.
A comprehensive search was done on PubMed/MEDLINE, EMBASE, Web of Science (WOS/ ISI), Scopus, ClinicalTrials (www.
gov), and conferences/ congress research papers. Random effect models were used to calculate mean differences (%) and risk ratios (RRs), and confidence intervals (95%).
Ten studies (n=1489 patients) were included in this study. PCSK9 inhibitors decreased the levels of LDL-C by -49.59% (95%CI -55.5%, -43.67%) as compared to placebo. They also didn't alter the Treatment-Emergent Adverse Event (TEAE) and neuronal events by RR 0.92 (0.75, 1.13) and 1.31 (0.66, 2.59), respectively. PCSK9 inhibitors were effective and safe in treating patients with FH.
There was high-quality evidence showing that monoclonal antibodies (alirocumab & evolocumab) lower LDL-C (GRADE: high), lipoprotein (a) (GRADE: High), triglycerides (TG) (GRADE: High), total cholesterol (GRADE: High), non-high-density lipoprotein cholesterol (non- HDL-C) (GRADE: Moderate), and apolipoprotein B (GRADE: High), and increase the HDL-C (GRADE: High) as well as apolipoprotein A1 (GRADE: High). Comparing PCSK9 inhibitors against placebo, neither TEAE (GRADE: high) nor neuronal events (GRADE: moderate) were changed.
家族性高胆固醇血症（FH）是一种常见且可能致命的疾病，会导致低密度脂蛋白胆固醇（LDL-C）大幅升高。
本研究旨在探讨单克隆抗体阿利西尤单抗和依洛尤单抗对LDL-C及其他血脂参数的影响，以及它们在家族性高胆固醇血症患者中的安全性。
对PubMed/MEDLINE、EMBASE、科学网（WOS/ISI）、Scopus、临床试验（www.CLINICALTRIALS.gov）以及会议/大会研究论文进行全面检索。采用随机效应模型计算平均差异（%）和风险比（RRs）以及置信区间（95%）。
本研究纳入了10项研究（n = 1489例患者）。与安慰剂相比，前蛋白转化酶枯草溶菌素9（PCSK9）抑制剂使LDL-C水平降低了-49.59%（95%CI -55.5%，-43.67%）。它们也未分别通过RR 0.92（0.75，1.13）和1.31（0.66，2.59）改变治疗引发的不良事件（TEAE）和神经事件。PCSK9抑制剂在治疗FH患者方面有效且安全。
有高质量证据表明单克隆抗体（阿利西尤单抗和依洛尤单抗）可降低LDL-C（证据等级：高）、脂蛋白（a）（证据等级：高）、甘油三酯（TG）（证据等级：高）、总胆固醇（证据等级：高）、非高密度脂蛋白胆固醇（非HDL-C）（证据等级：中等）和载脂蛋白B（证据等级：高），并升高HDL-C（证据等级：高）以及载脂蛋白A1（证据等级：高）。与安慰剂相比，PCSK9抑制剂既未改变TEAE（证据等级：高）也未改变神经事件（证据等级：中等）。
