Lancet:房颤患者采用新型FXIa小分子抑制剂Asundexian预防卒中的效果和安全性

2022-04-07 Nebula MedSci原创

房颤患者采用新型FXIa小分子抑制剂Asundexian预防卒中的效果不劣于阿哌沙班,且安全性好

心房颤动患者采用直接作用的口服抗凝剂预防卒中受到出血风险的限制。Asundexian是一种新型的口服的激活的凝血因子XIa(FXIa)的小分子抑制剂,有望在不怎么影响出血风险的情况下减少血栓形成。

本研究是一项国际性、多中心、随机、双盲的2期剂量探索性研究,旨在明确Asundexian的最佳剂量,并对比采用Asundexian或阿哌沙班治疗的房颤患者的出血率。

招募了45岁及以上、CHA2DS2-VASc评分≥2/3分(男性≥2分,女性≥3分)且出血风险升高的房颤患者,每日予以Asundexian(20 mg 或 50 mg,1/日)或阿哌沙班(5 mg,2/日)口服抗凝。主要终点是大出血或临床相关的非大出血的复合结局。

2020年1月30日至2021年6月21日,共招募了862位患者,其中755位被随机分至各治疗组。有两位分至Asundexian 20 mg组的患者未服用研究药物,被排除分析,故有753位患者被纳入最终分析:Asundexian 20 mg组 249位,Asundexian 50 mg组 254位,阿哌沙班组 250位。受试患者的中位年龄是73.7岁,41%的女性,216位(29%)患者合并慢性肾病,平均CHA2DS2-VASc评分为3.9分。


Asundexian两剂量组稳定后的FXIa活性

Asundexian 20 mg在谷浓度下可抑制81%的FXIa活性,在峰值浓度下可抑制90%的FXIa活性;Asundexian 50 mg在谷浓度下可抑制92%的FXIa活性,在峰值浓度下可抑制94%的FXIa活性。


各组主要终点的发生率和风险比

与阿哌沙班组(6例)相比,Asundexian 20mg组的主要终点的发生率比为0.50(3例),Asundexian 50mg组的主要终点的发生率比为0.16(1例),Asundexian组的汇总发生率比为0.33(4例)。三个治疗组的任何不良事件的发生率相似:Asundexian 20mg组 47%,Asundexian 50mg组 47%,阿哌沙班组 49%。

综上所述,与标准剂量的阿哌沙班相比,房颤患者采用FXIa抑制剂20 mg或50 mg(1/日)Asundexian治疗时,均可在出血率较低水平上几乎完全抑制体内FXIa活性。

原始出处:

Jonathan P Piccini, et al. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. The Lancet. April 03, 2022. https://doi.org/10.1016/S0140-6736(22)00456-1

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    2023-11-18 侠胆医心 来自加利福尼亚

    与标准剂量的#阿哌沙班#相比,#房颤#患者采用FXIa抑制剂20 mg或50 mg(1/日)#Asundexian#治疗时,均可在出血率较低水平上几乎完全抑制体内FXIa活性。#缺血性卒中#

    0

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    2022-09-09 howi
  3. [GetPortalCommentsPageByObjectIdResponse(id=2169215, encodeId=17db216921522, content=与标准剂量的<a href='/topic/show?id=95089e7452f' target=_blank style='color:#2F92EE;'>#阿哌沙班#</a>相比,<a href='/topic/show?id=737a54248f5' target=_blank style='color:#2F92EE;'>#房颤#</a>患者采用FXIa抑制剂20 mg或50 mg(1/日)<a href='/topic/show?id=39491046292a' target=_blank style='color:#2F92EE;'>#Asundexian#</a>治疗时,均可在出血率较低水平上几乎完全抑制体内FXIa活性。<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=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54248, encryptionId=737a54248f5, topicName=房颤), TopicDto(id=79359, encryptionId=fa10e93597f, topicName=缺血性卒中), TopicDto(id=97745, encryptionId=95089e7452f, topicName=阿哌沙班), TopicDto(id=104629, encryptionId=39491046292a, topicName=Asundexian)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sat Nov 18 02:53:41 CST 2023, time=2023-11-18, status=1, ipAttribution=加利福尼亚), GetPortalCommentsPageByObjectIdResponse(id=1831525, encodeId=62b118315252d, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Fri Sep 09 10:01:49 CST 2022, time=2022-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1914732, encodeId=62ba1914e32d0, content=<a href='/topic/show?id=84d7469559b' target=_blank style='color:#2F92EE;'>#小分子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46955, encryptionId=84d7469559b, topicName=小分子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6105386, createdName=宋威, createdTime=Fri Feb 10 20:01:49 CST 2023, time=2023-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852935, encodeId=c64d1852935c7, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 10 23:01:49 CST 2022, time=2022-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678219, encodeId=663a16e821976, content=<a href='/topic/show?id=f34c46963cc' target=_blank style='color:#2F92EE;'>#小分子抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46963, encryptionId=f34c46963cc, topicName=小分子抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b6f27658858, createdName=lqrandywkz, createdTime=Fri Aug 26 02:01:49 CST 2022, time=2022-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614639, encodeId=6b651614639de, content=<a href='/topic/show?id=64f95426122' target=_blank style='color:#2F92EE;'>#房颤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54261, encryptionId=64f95426122, topicName=房颤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=937e19519012, createdName=hittouch, createdTime=Wed Apr 06 14:01:49 CST 2022, time=2022-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243959, encodeId=bb101243959bc, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Tue Apr 05 02:01:49 CST 2022, time=2022-04-05, status=1, ipAttribution=)]
    2023-02-10 宋威
  4. [GetPortalCommentsPageByObjectIdResponse(id=2169215, encodeId=17db216921522, content=与标准剂量的<a href='/topic/show?id=95089e7452f' target=_blank style='color:#2F92EE;'>#阿哌沙班#</a>相比,<a href='/topic/show?id=737a54248f5' target=_blank style='color:#2F92EE;'>#房颤#</a>患者采用FXIa抑制剂20 mg或50 mg(1/日)<a href='/topic/show?id=39491046292a' target=_blank style='color:#2F92EE;'>#Asundexian#</a>治疗时,均可在出血率较低水平上几乎完全抑制体内FXIa活性。<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=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54248, encryptionId=737a54248f5, topicName=房颤), TopicDto(id=79359, encryptionId=fa10e93597f, topicName=缺血性卒中), TopicDto(id=97745, encryptionId=95089e7452f, topicName=阿哌沙班), TopicDto(id=104629, encryptionId=39491046292a, topicName=Asundexian)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sat Nov 18 02:53:41 CST 2023, time=2023-11-18, status=1, ipAttribution=加利福尼亚), GetPortalCommentsPageByObjectIdResponse(id=1831525, encodeId=62b118315252d, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Fri Sep 09 10:01:49 CST 2022, time=2022-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1914732, encodeId=62ba1914e32d0, content=<a href='/topic/show?id=84d7469559b' target=_blank style='color:#2F92EE;'>#小分子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46955, encryptionId=84d7469559b, topicName=小分子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6105386, createdName=宋威, createdTime=Fri Feb 10 20:01:49 CST 2023, time=2023-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852935, encodeId=c64d1852935c7, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 10 23:01:49 CST 2022, time=2022-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678219, encodeId=663a16e821976, content=<a href='/topic/show?id=f34c46963cc' target=_blank style='color:#2F92EE;'>#小分子抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46963, encryptionId=f34c46963cc, topicName=小分子抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b6f27658858, createdName=lqrandywkz, createdTime=Fri Aug 26 02:01:49 CST 2022, time=2022-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614639, encodeId=6b651614639de, content=<a href='/topic/show?id=64f95426122' target=_blank style='color:#2F92EE;'>#房颤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54261, encryptionId=64f95426122, topicName=房颤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=937e19519012, createdName=hittouch, createdTime=Wed Apr 06 14:01:49 CST 2022, time=2022-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243959, encodeId=bb101243959bc, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Tue Apr 05 02:01:49 CST 2022, time=2022-04-05, status=1, ipAttribution=)]
    2022-06-10 jklm09
  5. [GetPortalCommentsPageByObjectIdResponse(id=2169215, encodeId=17db216921522, content=与标准剂量的<a href='/topic/show?id=95089e7452f' target=_blank style='color:#2F92EE;'>#阿哌沙班#</a>相比,<a href='/topic/show?id=737a54248f5' target=_blank style='color:#2F92EE;'>#房颤#</a>患者采用FXIa抑制剂20 mg或50 mg(1/日)<a href='/topic/show?id=39491046292a' target=_blank style='color:#2F92EE;'>#Asundexian#</a>治疗时,均可在出血率较低水平上几乎完全抑制体内FXIa活性。<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=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54248, encryptionId=737a54248f5, topicName=房颤), TopicDto(id=79359, encryptionId=fa10e93597f, topicName=缺血性卒中), TopicDto(id=97745, encryptionId=95089e7452f, topicName=阿哌沙班), TopicDto(id=104629, encryptionId=39491046292a, topicName=Asundexian)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sat Nov 18 02:53:41 CST 2023, time=2023-11-18, status=1, ipAttribution=加利福尼亚), GetPortalCommentsPageByObjectIdResponse(id=1831525, encodeId=62b118315252d, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Fri Sep 09 10:01:49 CST 2022, time=2022-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1914732, encodeId=62ba1914e32d0, content=<a href='/topic/show?id=84d7469559b' target=_blank style='color:#2F92EE;'>#小分子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46955, encryptionId=84d7469559b, topicName=小分子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6105386, createdName=宋威, createdTime=Fri Feb 10 20:01:49 CST 2023, time=2023-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852935, encodeId=c64d1852935c7, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 10 23:01:49 CST 2022, time=2022-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678219, encodeId=663a16e821976, content=<a href='/topic/show?id=f34c46963cc' target=_blank style='color:#2F92EE;'>#小分子抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46963, encryptionId=f34c46963cc, topicName=小分子抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b6f27658858, createdName=lqrandywkz, createdTime=Fri Aug 26 02:01:49 CST 2022, time=2022-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614639, encodeId=6b651614639de, content=<a href='/topic/show?id=64f95426122' target=_blank style='color:#2F92EE;'>#房颤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54261, encryptionId=64f95426122, topicName=房颤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=937e19519012, createdName=hittouch, createdTime=Wed Apr 06 14:01:49 CST 2022, time=2022-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243959, encodeId=bb101243959bc, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Tue Apr 05 02:01:49 CST 2022, time=2022-04-05, status=1, ipAttribution=)]
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  7. [GetPortalCommentsPageByObjectIdResponse(id=2169215, encodeId=17db216921522, content=与标准剂量的<a href='/topic/show?id=95089e7452f' target=_blank style='color:#2F92EE;'>#阿哌沙班#</a>相比,<a href='/topic/show?id=737a54248f5' target=_blank style='color:#2F92EE;'>#房颤#</a>患者采用FXIa抑制剂20 mg或50 mg(1/日)<a href='/topic/show?id=39491046292a' target=_blank style='color:#2F92EE;'>#Asundexian#</a>治疗时,均可在出血率较低水平上几乎完全抑制体内FXIa活性。<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=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54248, encryptionId=737a54248f5, topicName=房颤), TopicDto(id=79359, encryptionId=fa10e93597f, topicName=缺血性卒中), TopicDto(id=97745, encryptionId=95089e7452f, topicName=阿哌沙班), TopicDto(id=104629, encryptionId=39491046292a, topicName=Asundexian)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sat Nov 18 02:53:41 CST 2023, time=2023-11-18, status=1, ipAttribution=加利福尼亚), GetPortalCommentsPageByObjectIdResponse(id=1831525, encodeId=62b118315252d, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Fri Sep 09 10:01:49 CST 2022, time=2022-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1914732, encodeId=62ba1914e32d0, content=<a href='/topic/show?id=84d7469559b' target=_blank style='color:#2F92EE;'>#小分子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46955, encryptionId=84d7469559b, topicName=小分子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6105386, createdName=宋威, createdTime=Fri Feb 10 20:01:49 CST 2023, time=2023-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852935, encodeId=c64d1852935c7, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 10 23:01:49 CST 2022, time=2022-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678219, encodeId=663a16e821976, content=<a href='/topic/show?id=f34c46963cc' target=_blank style='color:#2F92EE;'>#小分子抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46963, encryptionId=f34c46963cc, topicName=小分子抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b6f27658858, createdName=lqrandywkz, createdTime=Fri Aug 26 02:01:49 CST 2022, time=2022-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614639, encodeId=6b651614639de, content=<a href='/topic/show?id=64f95426122' target=_blank style='color:#2F92EE;'>#房颤患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54261, encryptionId=64f95426122, topicName=房颤患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=937e19519012, createdName=hittouch, createdTime=Wed Apr 06 14:01:49 CST 2022, time=2022-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243959, encodeId=bb101243959bc, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Tue Apr 05 02:01:49 CST 2022, time=2022-04-05, status=1, ipAttribution=)]
    2022-04-05 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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