欧盟批准利伐沙班用于急性冠状动脉综合征的二级预防

2013-05-27 MedScape dxy

5月24日，拜耳宣布欧洲委员会批准口服凝血因子Xa抑制剂利伐沙班（拜瑞妥，拜耳/杨森制药）用于生物标志物确诊的急性冠状动脉综合征(ACS)成人患者的二级预防。针对该适应症，利伐沙班每天服用两次，每次2.5 mg，并与标准抗血小板治疗药物合并用药。今年3月份，欧洲药品管理局（EMA）人用医药产品委员会(CHMP)主要基于随机的、有15000多名患者参与的ATLAS ACS 2 TIMI 51临床

5月24日，拜耳宣布欧洲委员会批准口服凝血因子Xa抑制剂利伐沙班（拜瑞妥，拜耳/杨森制药）用于生物标志物确诊的急性冠状动脉综合征(ACS)成人患者的二级预防。针对该适应症，利伐沙班每天服用两次，每次2.5 mg，并与标准抗血小板治疗药物合并用药。

今年3月份，欧洲药品管理局（EMA）人用医药产品委员会(CHMP)主要基于随机的、有15000多名患者参与的ATLAS ACS 2 TIMI 51临床试验就已推荐批准利伐沙班用于治疗急性冠状动脉综合征。临床试验中，每日服用两次2.5mg剂量的利伐沙班，与安慰剂相比，尽管会增加出血和颅内出血(ICH)的风险，但能够降低总体死亡率和心血管病死亡率。临床试验中同时也检测了5mg剂量的利伐沙班，但与其有关的出血风险超过其带来的治疗收益。

对于新一代口服抗凝血药，相其它适应症，急性冠状动脉综合征在寻求美国和欧洲药品监管机构批准时往往会面临更多的挑战。例如今年3月份，美国FDA推迟了利伐沙班用于急性冠状动脉综合征二级预防的这一备受期待的审批决定，同时FDA要求公司提供更多的安全性数据。

版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言

评论区 (3)

#插入话题

插入图片

[GetPortalCommentsPageByObjectIdResponse(id=1706813, encodeId=07481e0681333, content=<a href='/topic/show?id=15bd30902cc' target=_blank style='color:#2F92EE;'>#冠状动脉综合征#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30902, encryptionId=15bd30902cc, topicName=冠状动脉综合征)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=345831322662, createdName=124985dbm16(暂无昵称), createdTime=Mon Mar 24 18:10:00 CST 2014, time=2014-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1430384, encodeId=6d2f1430384a7, content=<a href='/topic/show?id=f9b9e9124a8' target=_blank style='color:#2F92EE;'>#综合征#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79124, encryptionId=f9b9e9124a8, topicName=综合征)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Wed May 29 05:10:00 CST 2013, time=2013-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589918, encodeId=d267158991826, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Wed May 29 05:10:00 CST 2013, time=2013-05-29, status=1, ipAttribution=)]
2014-03-24 124985dbm16(暂无昵称)

#冠状动脉综合征#

74 0
[GetPortalCommentsPageByObjectIdResponse(id=1706813, encodeId=07481e0681333, content=<a href='/topic/show?id=15bd30902cc' target=_blank style='color:#2F92EE;'>#冠状动脉综合征#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30902, encryptionId=15bd30902cc, topicName=冠状动脉综合征)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=345831322662, createdName=124985dbm16(暂无昵称), createdTime=Mon Mar 24 18:10:00 CST 2014, time=2014-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1430384, encodeId=6d2f1430384a7, content=<a href='/topic/show?id=f9b9e9124a8' target=_blank style='color:#2F92EE;'>#综合征#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79124, encryptionId=f9b9e9124a8, topicName=综合征)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Wed May 29 05:10:00 CST 2013, time=2013-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589918, encodeId=d267158991826, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Wed May 29 05:10:00 CST 2013, time=2013-05-29, status=1, ipAttribution=)]
2013-05-29 zhouqu_8

#综合征#

102 0
[GetPortalCommentsPageByObjectIdResponse(id=1706813, encodeId=07481e0681333, content=<a href='/topic/show?id=15bd30902cc' target=_blank style='color:#2F92EE;'>#冠状动脉综合征#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30902, encryptionId=15bd30902cc, topicName=冠状动脉综合征)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=345831322662, createdName=124985dbm16(暂无昵称), createdTime=Mon Mar 24 18:10:00 CST 2014, time=2014-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1430384, encodeId=6d2f1430384a7, content=<a href='/topic/show?id=f9b9e9124a8' target=_blank style='color:#2F92EE;'>#综合征#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79124, encryptionId=f9b9e9124a8, topicName=综合征)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Wed May 29 05:10:00 CST 2013, time=2013-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589918, encodeId=d267158991826, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Wed May 29 05:10:00 CST 2013, time=2013-05-29, status=1, ipAttribution=)]
2013-05-29 chenwq14

#欧盟批准#

109 0

内科

外科

专科科室

热点

按科室浏览

临床工具

科研工具

其他工具

科研数智化

真实世界研究解决方案

数字化学术传播解决方案

其它

心血管

欧盟批准利伐沙班用于急性冠状动脉综合征的二级预防

相关资讯

科室

工具

服务