Drug therapies targeted at the reduction of low-density lipoproteincholesterol (LDL-C) are mainstream in the treatment of cardiovascular disease (CVD) and particularly for the prevention of coronary heart disease. In patients who do not have a sufficient response to, or who do not tolerate traditional LDL-C-lowering therapies such as statins or ezetimibe, monoclonal antibodies (mAbs) against PCSK9 (PCSK9 inhibitors) may provide an alternative treatment. Non-mAb-based PCSK9 inhibitors such as inclisiran are also emerging but currently lack robust outcome data1 and their effects are not considered in the current review. In this synopsis, we summarise findings from a recent update of a Cochrane systematic review on the efficacy and safety of PCSK9 inhibitors.2 This article focuses on the effects on outcomes (CVD and total mortality), safety, and the quality of the evidence in studies of mAb PCSK9 inhibitors alirocumab and evolocumab. Most of the available studies compared PCSK9 mAb treatment against placebo (against a background of usual care including statin and or ezetimibe), with a smaller group of studies evaluating the effects of PCSK9 mAb directly against statins and/or ezetimibe (none of the trials compared PCSK9 exclusively against statin treatment). The following databases were systematically searched for suitable randomised controlled trials (RCTs): Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Web of Science, ClinicalTrials.gov and the International Clinical …

中文翻译：

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Cochrane 角：PCSK9 单克隆抗体用于心血管疾病一级和二级预防


以降低低密度脂蛋白胆固醇（LDL-C）为目标的药物疗法是心血管疾病（CVD）治疗的主流，特别是预防冠心病。对于对他汀类药物或依折麦布等传统 LDL-C 降低疗法没有足够反应或不能耐受的患者，针对 PCSK9（PCSK9 抑制剂）的单克隆抗体 (mAb) 可能提供替代治疗。非单克隆抗体 PCSK9 抑制剂（例如 inclisiran）也在不断涌现，但目前缺乏可靠的结果数据1，并且当前的综述中未考虑其作用。在本概要中，我们总结了最近更新的 Cochrane 系统评价关于 PCSK9 抑制剂的功效和安全性的结果。2 本文重点关注对结果（CVD 和总死亡率）、安全性和证据质量的影响。 mAb PCSK9 抑制剂 alirocumab 和 evolocumab 的研究。大多数现有研究将 PCSK9 mAb 治疗与安慰剂进行比较（在常规护理的背景下，包括他汀类药物和/或依折麦布），一小部分研究评估了 PCSK9 mAb 直接对抗他汀类药物和/或依折麦布的效果（没有一项试验比较PCSK9 专门针对他汀类药物治疗）。系统地搜索了以下数据库以寻找合适的随机对照试验 (RCT)：Cochrane 对照试验中央注册库、MEDLINE、Embase、Web of Science、ClinicalTrials.gov 和 International Clinical …