FDA批准替格瑞洛用于降低卒中风险

2020-11-09 MedSci原创 MedSci原创

与单独使用阿司匹林相比,连续30天每天服用两次Brilinta联合阿司匹林,将中风和死亡发生率降低了17%。

阿斯利康周五表示,FDA批准使用Brilinta(ticagrelor,替格瑞洛)用于降低急性缺血性中风或高危短暂性脑缺血发作(TIA)患者的中风风险,此次批准将其应用范围从血管疾病(CV)扩展到轻度至中度的中风患者。Brilinta是口服的P2Y12受体拮抗剂。这是基于THALES试验的结果,该结果是2020年夏天发表在新英格兰杂志上。

 AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

图片来源:www.pharmashots.com

此次批准是基于III期THALES试验结果,该试验对11000多名急性缺血性中风或TIA患者进行了研究。结果显示,与单独使用阿司匹林相比,连续30天每天服用两次Brilinta联合阿司匹林,将中风和死亡发生率降低了17%。

The THALES Trial(图片来源:Claiborne Johnston S et al. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. NEJM 2020)

接受Brilinta加阿司匹林的患者发生严重出血的风险为0.5%,仅接受阿司匹林的患者为0.1%,而两组的颅内出血和致命性出血的发生率分别为0.4%和0.1%。阿斯利康表示,这一发现与Brilinta的已知安全性相符。

THALES试验的主要研究者Clay Johnston指出:“四分之一的中风患者会经历第二次中风,头30天内的风险特别高。”他补充说,Brilinta与阿司匹林联用的批准是“减少中风复发风险的重大进展。”

注:这项研究与2015年中国的CHANCE研究结果一致。CHANCE研究使用的是氯吡格雷

阿斯利康最近报告显示,Brilinta第三季度的销售额为3.85亿美元,较去年同期下降7%。

原始出处:

https://beta.firstwordpharma.com/story/5146125

Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA.N Engl J Med. 2020 Jul 16;383(3):207-217

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    2021-08-25 bugit
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    2020-11-09 Psycho.Dr Du

    需重视高危短暂性脑缺血发作(TIA)患者的卒中风险#卒中#

    0

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    2020-11-09 健健

    卒中虽然是临床上常见病,溶栓,取栓等血管内治疗也很成熟,但是仍然有很多未知问题有待认知!

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1249461, encodeId=b79012494619f, content=<a href='/topic/show?id=eb103e35fe' target=_blank style='color:#2F92EE;'>#Brilinta#</a>(即<a href='/topic/show?id=43666034930' target=_blank style='color:#2F92EE;'>#替格瑞洛#</a>)<a href='/topic/show?id=fa10e93597f' target=_blank style='color:#2F92EE;'>#缺血性卒中#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3735, encryptionId=eb103e35fe, topicName=Brilinta), TopicDto(id=60349, encryptionId=43666034930, topicName=替格瑞洛), TopicDto(id=79359, encryptionId=fa10e93597f, topicName=缺血性卒中)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=小小医者, createdTime=Sat Sep 17 06:04:05 CST 2022, time=2022-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839888, encodeId=cefa183988855, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Aug 25 23:13:15 CST 2021, time=2021-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1281352, encodeId=46bc128135219, content=<a href='/topic/show?id=455f36085f0' target=_blank style='color:#2F92EE;'>#卒中风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36085, encryptionId=455f36085f0, topicName=卒中风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Nov 11 05:13:15 CST 2020, time=2020-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=898013, encodeId=3fe889801342, content=需重视高危短暂性脑缺血发作(TIA)患者的卒中风险<a href='/topic/show?id=b64035999ca' target=_blank style='color:#2F92EE;'>#卒中#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35999, encryptionId=b64035999ca, topicName=卒中)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210607/9f00a0de660e4b36b77a9a5f7620d6bf/98c22b17ddf7446fa7b9a618fabcb9f7.jpg, createdBy=a8fb2299762, createdName=Psycho.Dr Du, createdTime=Mon Nov 09 18:08:06 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1026711, encodeId=f95e1026e1192, content=卒中虽然是临床上常见病,溶栓,取栓等血管内治疗也很成熟,但是仍然有很多未知问题有待认知!, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=健健, createdTime=Mon Nov 09 17:13:15 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1045990, encodeId=572110459903f, content=中风是俗称,应该称为缺血性卒中吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=guging, createdTime=Mon Nov 09 17:13:15 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=897988, encodeId=299089e988fa, content=与单独使用阿司匹林相比,连续30天每天服用两次Brilinta联合阿司匹林,将中风和死亡发生率降低了17%, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b58d5402080, createdName=咻凡, createdTime=Mon Nov 09 15:46:03 CST 2020, time=2020-11-09, status=1, ipAttribution=)]
    2020-11-09 guging

    中风是俗称,应该称为缺血性卒中吧

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1249461, encodeId=b79012494619f, content=<a href='/topic/show?id=eb103e35fe' target=_blank style='color:#2F92EE;'>#Brilinta#</a>(即<a href='/topic/show?id=43666034930' target=_blank style='color:#2F92EE;'>#替格瑞洛#</a>)<a href='/topic/show?id=fa10e93597f' target=_blank style='color:#2F92EE;'>#缺血性卒中#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3735, encryptionId=eb103e35fe, topicName=Brilinta), TopicDto(id=60349, encryptionId=43666034930, topicName=替格瑞洛), TopicDto(id=79359, encryptionId=fa10e93597f, topicName=缺血性卒中)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=小小医者, createdTime=Sat Sep 17 06:04:05 CST 2022, time=2022-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839888, encodeId=cefa183988855, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Aug 25 23:13:15 CST 2021, time=2021-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1281352, encodeId=46bc128135219, content=<a href='/topic/show?id=455f36085f0' target=_blank style='color:#2F92EE;'>#卒中风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36085, encryptionId=455f36085f0, topicName=卒中风险)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Nov 11 05:13:15 CST 2020, time=2020-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=898013, encodeId=3fe889801342, content=需重视高危短暂性脑缺血发作(TIA)患者的卒中风险<a href='/topic/show?id=b64035999ca' target=_blank style='color:#2F92EE;'>#卒中#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35999, encryptionId=b64035999ca, topicName=卒中)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210607/9f00a0de660e4b36b77a9a5f7620d6bf/98c22b17ddf7446fa7b9a618fabcb9f7.jpg, createdBy=a8fb2299762, createdName=Psycho.Dr Du, createdTime=Mon Nov 09 18:08:06 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1026711, encodeId=f95e1026e1192, content=卒中虽然是临床上常见病,溶栓,取栓等血管内治疗也很成熟,但是仍然有很多未知问题有待认知!, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=健健, createdTime=Mon Nov 09 17:13:15 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1045990, encodeId=572110459903f, content=中风是俗称,应该称为缺血性卒中吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=guging, createdTime=Mon Nov 09 17:13:15 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=897988, encodeId=299089e988fa, content=与单独使用阿司匹林相比,连续30天每天服用两次Brilinta联合阿司匹林,将中风和死亡发生率降低了17%, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b58d5402080, createdName=咻凡, createdTime=Mon Nov 09 15:46:03 CST 2020, time=2020-11-09, status=1, ipAttribution=)]
    2020-11-09 咻凡

    与单独使用阿司匹林相比,连续30天每天服用两次Brilinta联合阿司匹林,将中风和死亡发生率降低了17%

    0

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