CIT 2018:FDA新药审批顾问:抗血小板治疗的传说与现实

2018-04-05 国际循环编辑部 国际循环

2018年3月22~25日,在第十六届中国介入心脏病学大会(CIT 2018)的药物学研讨会专场,与会专家聚焦临床研究热点,就ST段抬高型心肌梗死(STEMI)溶栓患者的优化抗栓策略、急性冠状动脉综合征(ACS)患者心肌梗死后的长期抗栓选择等进行了激烈的讨论交流。

2018年3月22~25日,在第十六届中国介入心脏病学大会(CIT 2018)的药物学研讨会专场,与会专家聚焦临床研究热点,就ST段抬高型心肌梗死(STEMI)溶栓患者的优化抗栓策略、急性冠状动脉综合征(ACS)患者心肌梗死后的长期抗栓选择等进行了激烈的讨论交流。关于抗血小板治疗药物如何选择,美国食品药品监督管理局(FDA)新药审批顾问、美国约翰霍普金斯大学医学副教授Victor L. Serebruany在报告中表示,虽然FDA批准了替格瑞洛急性冠状动脉综合征(ACS)适应症,但FDA在审评替格瑞洛的过程中对新药申请进行了多方面评估和二次审核,其有效性及安全性问题存在诸多疑点。Serebruany教授对已发表的文献进行梳理,对其审批、研究的执行及监管等进行了详细解读



表1. FDA关于替格瑞洛审批的审查和建议 

表格1提示,在FDA的审批中,有关替格瑞洛临床安全性、有效性、综合评估和统计学的审查遭到强烈反对,并未得到批准。另外,还有一位小组负责人提出需排除行早期PCI的STEMI患者,即有条件的批准。然而,审查组的部门负责人和办公室负责人基于提供的相关文件最终批准了替格瑞洛上市。 但反对者并不认可提交文件中关于阿司匹林剂量影响的理论可解释PLATO在北美的不同结果,且提出非常有必要在美国进行一项验证性ACS临床研究[5-6]。PEGASUS研究就是迫于该目的,但其录入的为稳定冠心病患者,结果不足以支持ACS适应症。下面是对FDA审查员的主要关注点的详细阐述。

一.对替格瑞洛有效性的质疑

1. 美国地区研究结果显示,氯吡格雷优于替格瑞洛。有关阿司匹林剂量降低替格瑞洛复合终点事件的临床疗效的解释,尚缺乏足够的证据支持。



图1. PLATO研究在美国人群中的结局

2. 在进行早期PCI的患者中,氯吡格雷优于替格瑞洛。

PLATO研究中,绝大部分患者进行了早期PCI治疗。研究结果表明,与氯吡格雷相比,替格瑞洛显著增加早期PCI患者(24 h)全因死亡率(30天达1.89倍,研究结束时达1.41倍)和心血管死亡率(30天达1.31倍,研究结束时达1.35倍)。



图2. 替格瑞洛在早期PCI患者中死亡风险显著增高

3. 中心判断委员会与临床中心报告结果存在反常巨大差异,替格瑞洛在MI的优势需重新审视。临床研究不良事件的报告通常由研究中心进行上报,对于有疑问的病例将由独立的中心判断委员会进行裁决,而FDA的二次审查是针对临床中心的原始报告。中心判断委员会判断后,替格瑞洛预防MI上的获益比氯吡格雷要多出一倍(Δ=89),但临床中心报道事件差距不显著(差距仅44)。假设一个双盲判断委员会发现一例未诊断MI,这起事件属于氯吡格雷组的概率是52.2%。因此,委员会若发现45例未诊断MIs,全部属于氯吡格雷组的概率为0.0000000000002(5万亿分之一)。这个发现并不意味着这些独立且经验丰富的中心判断委员会有意偏袒,只是提示PLATO发起者可能只发送了氯吡格雷组的案例给中心判断委员会,而消除有疑问的替格瑞洛CRFs,从而夸大了替格瑞洛的优势。

4.尽管基于中心事件判断的官方分析说明替格瑞洛在死亡率上有优势,但FDA二次审查的临床中心原始报道的事件计数主要终点并无差异(P=0.095)。

二、对研究执行的质疑

1. 缺乏血脂相关的用药记录。PLATO没有对他汀类药物进行恰当的限制,没有记录他汀类用量,没有记录大部分患者的血脂水平。

2. 有一部分患者变成非盲。在PLATO试验中,通过研碎氯吡格雷/安慰剂氯吡格雷片剂很容易变成非盲。发起者有递交说明,表示仅32例患者在临床中心变成了非盲。事实上,稍后发现有452例患者在数据库锁定之前就已变成了非盲。

3. 报道事件时有太多的“人为记录错误”。根据所得信息很难判断究竟是无意错误还是随机编码操作。

4. PLATO中记录和提交的日期和时间存在疑点。因为错误记录了日期或时间,发起者至少消除了3起替格瑞洛主要终点事件。

5. 替格瑞洛组事件发生的分布存疑。替格瑞洛未报道出血事件表现为非正态分布,氯吡格雷的未报道出血事件分布较均匀。PLATO研究者在发起者删除数据后,立即报道了16起主要终点事件,而氯吡格雷则无此类情况。另外,30起未报道出血事件中有26起发生在早期停用替格瑞洛后。相比氯吡格雷组,替格瑞洛组多出47例患者撤回同意书,多出87例患者不愿完成研究。



6. 出血事件记录不完整。PLATO结果显示更多PCI相关的出血事件,但没有确认替格瑞洛患者与冠状动脉旁路移植相关的轻微出血事件。

7. PLATO的随访不完整,长期结果不可信。尽管PLATO是一项<60%患者需至少跟踪360天的短期结果研究,但研究结束时,存活的患者中约有19%在研究最早间或之后未进行生命体征的随访(19.7%替格瑞洛 vs 18.1% 氯吡格雷)。没有进行生命体征随访和没有主要终点的替格瑞洛患者数量过多,超过了报道的主要终点差值。缺乏最终关键生命体征和严重心血管不良反应终点的替格瑞洛患者远远超过了其他报道的相同终点差值。

8. 研究发起者没有提供完整的临床研究记录,包括严重不良反应记录。例如:1例替格瑞洛患者在第22天因为冠状动脉血栓住院,记录包括肌钙蛋白T水平>5倍正常水平上限,心脏超声检查显示射血分数为55%,下壁运动减弱。没有提供这起事件关于症状,体检结果,实验室检测,治疗方案,先前联合用药或住院期间相关信息。发起者对患者揭盲,但没有提交该事件给予中心判断,因为研究者认为该事件和研究药物无关。

总之,替格瑞洛的安全性问题不仅引发FDA关注,更值得临床研究者和医生深思,在选择抗血小板药物时应客观、全面评估其有效性和安全性,尽可能选择疗效确切、安全性好的药物。2013 ACCF/ AHA美国STEMI指南基于此,对于直接PCI患者应给予负荷剂量的P2Y12受体抑制剂至少治疗1年。氯吡格雷负荷剂量600 mg (Ⅰ,B) 或普拉格雷60 mg、替格瑞洛180 mg(Ⅰ,B);氯吡格雷维持剂量75 mg/天,普拉格雷10mg/天。对于接受溶栓治疗的STEMI 患者,应该给予阿司匹林(162~325 mg 负荷剂量)和氯吡格雷(≤75岁,300 mg 负荷剂量;>75 岁,75 mg 剂量)。因PLATO研究中存在的许多问题,在基于现有真实世界证据下,选择氯吡格雷更为安全、可靠。

此外,为将PLATO研究中替格瑞洛治疗后患者的可观获益推广至东亚患者,尤其是日本ACS患者,开展了PHILO研究,其为PLATO研究的镜像设计。但结果并未达到预期临床获益,未在日本获得批准上市。因此,对于东亚人群来说,可能选择氯吡格雷更适合。

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  4. 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    2018-04-07 wxl882001

    学习一下

    0

  5. 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    2018-04-07 虈亣靌

    学习了.谢谢作者分享!

    0

  6. 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likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 06 08:29:31 CST 2018, time=2018-04-06, status=1, ipAttribution=)]
    2018-04-07 张新亮1853311252142e2fm

    好文献.学习了

    0

  7. 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    2018-04-07 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

  8. 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    2018-04-06 137****8002

    不错!学习了

    0

  9. 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    2018-04-06 三生有幸9135

    学习一下谢谢分享

    0

  10. 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    2018-04-06 yfjms

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