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2018AHA热点持续升温！PCSK9抑制剂再添新证

2018-11-13 中国心血管健康联盟进阶学院 MedSci原创

抑制剂
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AHA科学年会如火如荼的进行当中，PCSK9抑制剂作为本次大会讨论的热点之一，亦有众多精彩内容呈现！

AHA科学年会如火如荼的进行当中，PCSK9抑制剂作为本次大会讨论的热点之一，亦有众多精彩内容呈现！

FOURIER亚组研究分析：PCSK9抑制剂对于存在MI病史患者的临床获益

FOURIER研究已为大众所熟知，依洛尤单抗在他汀治疗的基础上进一步降低LDL-C水平约60%。本次大会上，Marc Sabatine教授对FOURIER研究的亚组分析进行了汇报，分析纳入了22,351例既往发生MI的患者（总体队列的81%），针对三个特征将患者进行分组，包括既往发生MI的时间、基线时发生MI的次数以及基线时是否存在残余多支血管病变，在组间比较依洛尤单抗与安慰剂的疗效，并对患者的CV死亡、MI和卒中风险进行分析。

研究显示既往2年以内发生MI、MI发生次数2次以上和多血管病变均是CV死亡、MI和卒中的危险因素。而对于这些风险较高的患者，采用依洛尤单抗的获益更大。

在既往2年内发生MI的患者中，依洛尤单抗可降低相对风险24%，绝对风险2.9%。


同样的，在既往发生2次以上（含）MI的患者中，依洛尤单抗可降低相对风险21%，绝对风险2.6%。


对于合并多支血管病变的患者，依洛尤单抗的疗效更为显著，可降低相对风险30%，绝对风险3.4%。


Sabatine教授指出至少存在一个高危因素的患者占了亚组分析整体人群的63%。综合来看，存在1个以上（含）高风险因素的患者，依洛尤单抗治疗可降低相对风险22%，绝对风险2.5%。Landmark分析同样显示，依洛尤单抗治疗的获益在1年后更为显著。


总而言之，该亚组分析验证了依洛尤单抗对于既往存在MI病史患者的获益，特别是对于那些心血管事件高风险的患者，获益尤为显著。

亚洲人群使用PCSK9抑制剂获益

FOURIER研究和GLAGOV研究显示出PCSK9抑制剂对于缺血性心脏病患者的疗效。对于ASCVD二级预防而言，高风险患者应将LDL-C水平控制在70mg/dL以下。然而对于杂合子型家族性高胆固醇血症（HeFH）患者，通过传统的降脂药物很难达到这一靶标。来自东京的Sato教授在本次大会上发表了一篇研究，评估了PCSK9抑制剂在高风险HeFH患者中的疗效。

研究纳入了存在多种风险因素的HeFH患者，如既往CVD病史、男性35岁以上、女性45岁以上、TG＞150mg/dL、HDL-C＜40mg/dL、Lp(a)＞50mg/dL、跟腱黄色瘤＞15mm、吸烟、糖尿病、高血压或慢性肾病患者。对于无法获得理想LDL-C水平且已经接受最大耐受剂量他汀的患者采用PCSK9抑制剂治疗。同时，研究分析一级预防和二级预防的临床进程、临床特征、实验室生化数据、体格检查等。HeFH患者中位年龄59.4±13.2岁、BMI26.9±4.1kg/m2。研究发现，在接受PCSK9抑制剂治疗4周后，T-C、LDL-C、ApoB、Lp(a)和氧化LDL-C水平均有显著改善，治疗24周后颈动脉内膜中层厚度（IMT）、冠状动脉斑块显著消退。

PCSK9抑制剂除了可显著降低高风险HeFH患者血脂水平，同时改善了斑块形成，可预防未来心血管事件发生。


PCSK9抑制剂对于心肌缺血/再灌注损伤导致的脑损伤具有神经保护作用

心肌缺血/再灌注损伤（I/R）不仅会减少脑血流，同时会引起大脑线粒体功能异常，微神经胶质功能亢进和降低树突棘密度。PCSK9抑制剂作为新型降胆固醇药物显示出了减少细胞凋亡和炎症的作用，来自泰国的Chattipakorn团队在本次大会上就PCSK9抑制剂对于改善心肌I/R造成脑损伤作用进行评估。

研究采用成年雄性维斯塔鼠，分为假手术组（n=4）或心肌I/R手术组（n=40）。心肌I/R小鼠进一步分为4组（每组10只）：1）媒介组；2）缺血前使用PCSK9抑制剂组（10μg/kg IV）；3）缺血中给予PCSK9抑制剂组；4）再灌注时给予PCSK9抑制剂组。最后摘除大脑评估大脑线粒体形态、微神经胶质和星形细胞活性以及树突棘密度。

心肌I/R可通过增加CD11b+/CD45+high细胞、CD11b+/CD45+low细胞、和Iba1+微神经胶质细胞和GFAP+星形胶质细胞来激活大脑固有免疫。此外心肌I/R可导致微神经胶质和星形胶质细胞功能亢进，降低树突棘密度。但研究并没有发现线粒体功能异常。只有在缺血前使用PCSK9抑制剂具有神经保护作用。该研究显示，PCSK9抑制剂不仅有降胆固醇功能，还可减少心肌I/R对大脑带来的不利影响。

 

PCSK9抑制剂自上市以来就获得了广泛的关注，其卓越的降胆固醇疗效也已获得广泛认可，本次大会上，除了持续验证了PCSK9抑制剂对于心血管高风险患者的获益之外，还显示了其可能存在降胆固醇以外的获益，显示了PCSK9抑制剂未来更广阔的应用前景。但目前这些研究仅局限于小规模临床研究或者动物研究上，还需要更多的临床研究来探索及验证其额外获益！

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    2018-12-14 Tamikia

    #PCS#

    0

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    2018-12-06 wjywjy

    #PCSK9抑制#

    0

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    2019-10-22 FukaiBao

    #Csk#

    0

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    2019-02-04 jklm09

    #抑制剂#

    0

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    2018-11-15 zhaohui6731

    #AHA#

    0

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