JAMA:sPLA2抑制剂伐瑞拉迪增加ACS后短期内MI风险(VISTA-16研究)

2013-11-22 MedSci MedSci原创

一项国际随机临床试验(RCT)的结果显示,sPLA2抑制剂伐瑞拉迪不但不能降低近期急性冠脉综合征(ACS)患者的心血管事件风险,实际上反而会增加发生心肌梗死(MI)的风险。该研究结果在美国心脏协会(AHA)年会上发布,并同时刊登在JAMA在线版上。伐瑞拉迪是一种非特异性的分泌型磷酸酯酶A2(sPLA2)酶家族的抑制剂,这种酶参与炎症过程,其中一些可见于动脉粥样硬化病变和缺血损伤的心肌区域。在最初的

一项国际随机临床试验(RCT)的结果显示,sPLA2抑制剂伐瑞拉迪不但不能降低近期急性冠脉综合征(ACS)患者的心血管事件风险,实际上反而会增加发生心肌梗死(MI)的风险。该研究结果在美国心脏协会(AHA)年会上发布,并同时刊登在JAMA在线版上。

伐瑞拉迪是一种非特异性的分泌型磷酸酯酶A2(sPLA2)酶家族的抑制剂,这种酶参与炎症过程,其中一些可见于动脉粥样硬化病变和缺血损伤的心肌区域。在最初的研究中,这种药物可使ACS患者循环中sPLA2水平降低90%以上,并降低LDL胆固醇和C-反应蛋白水平。

VISTA-16试验是由伐瑞拉迪的生产商Anthera制药公司发起的,由澳大利亚阿德莱德市澳大利亚南方卫生与医学研究所的Stephen J. Nicholls博士及其同事实施,目的是评估该药物在ACS后最初4个月的高危时期内预防CV事件的疗效。3年期间,共纳入17个国家的362个医疗中心的5,145例表现ACS数小时内的患者。这些患者中CV风险因素和明确的动脉粥样硬化疾病的患病率很高,多数已在接受适当的抗血小板药物、他汀、受体阻滞剂、ACE抑制剂或ACE受体阻滞剂治疗。80%的患者在指示事件后接受冠脉再血管化。研究的主要终点为包括CV原因死亡、非致死性MI、非致死性卒中或需要住院治疗的不稳定心绞痛的复合终点。

结果显示,当试验终止时,记录了212例患者的结果,平均接受治疗的时间为13.4 周。接受伐瑞拉迪治疗的患者中有6.1%发生主要终点,安慰剂组的主要终点发生率为5.1%[危险比(HR)为1.25]。次要终点为包括CV原因死亡、MI和卒中的复合终点,伐瑞拉迪和安慰剂组次要终点发生率分别为4.6%和3.8%(HR,1.36)。“主要原因为伐瑞拉迪组MI发生率高于安慰剂组,分别为3.4%和2.2%(HR,1.66)。”停用研究药物治疗后6个月时,伐瑞拉迪组和安慰剂组的全因死亡率分别为2.7%和2.0%。活性药物治疗组因不良事件或严重不良事件停止治疗的比例为安慰剂组的2倍,分别为2.8%和1.4%。

这一药物确实展现了预期的对炎症和脂肪生物标记物的有益效应,理论上应该转化为ACS后治疗16周期间的斑块破裂倾向性降低。但在对于5,012例参与随机化的患者中的212例患者的结局进行中期分析之后,因活性药物“无益”而提前终止研究。


原始出处:
Nicholls SJ, Kastelein JJ, Schwartz GG, Bash D, Rosenson RS, Cavender MA, Brennan DM, Koenig W, Jukema JW, Nambi V, Wright RS, Menon V, Lincoff AM, Nissen SE; for the VISTA-16 Investigators. Varespladib and Cardiovascular Events in Patients With an Acute Coronary Syndrome: The VISTA-16 Randomized Clinical Trial.

JAMA. 2013 Nov 18. doi: 10.1001/jama.2013.282836.

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 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1851142, encodeId=cbe3185114284, 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=Thu Oct 30 22:19:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789101, encodeId=43141e8910129, content=<a href='/topic/show?id=34871434005' target=_blank style='color:#2F92EE;'>#PLA2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14340, encryptionId=34871434005, topicName=PLA2)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c2b4297, createdName=徐岩, createdTime=Mon Nov 03 06:19:00 CST 2014, time=2014-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995463, encodeId=c2b9199546335, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Jul 22 09:19:00 CST 2014, time=2014-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1669222, encodeId=e4b116692228f, content=<a href='/topic/show?id=561b1846324' target=_blank style='color:#2F92EE;'>#VISTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18463, encryptionId=561b1846324, topicName=VISTA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d46d26532205, createdName=muzishouyi, createdTime=Sun Mar 30 20:19:00 CST 2014, time=2014-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1279034, encodeId=ea9012e90342f, content=<a href='/topic/show?id=316d1882bc' target=_blank style='color:#2F92EE;'>#ACS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1882, encryptionId=316d1882bc, topicName=ACS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=102a153, createdName=yaanren, createdTime=Sun Nov 24 03:19:00 CST 2013, time=2013-11-24, status=1, ipAttribution=)]
    2014-10-30 jklm09
  2. [GetPortalCommentsPageByObjectIdResponse(id=1851142, encodeId=cbe3185114284, 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=Thu Oct 30 22:19:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789101, encodeId=43141e8910129, content=<a href='/topic/show?id=34871434005' target=_blank style='color:#2F92EE;'>#PLA2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14340, encryptionId=34871434005, topicName=PLA2)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c2b4297, createdName=徐岩, createdTime=Mon Nov 03 06:19:00 CST 2014, time=2014-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995463, encodeId=c2b9199546335, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Jul 22 09:19:00 CST 2014, time=2014-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1669222, encodeId=e4b116692228f, content=<a href='/topic/show?id=561b1846324' target=_blank style='color:#2F92EE;'>#VISTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18463, encryptionId=561b1846324, topicName=VISTA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d46d26532205, createdName=muzishouyi, createdTime=Sun Mar 30 20:19:00 CST 2014, time=2014-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1279034, encodeId=ea9012e90342f, content=<a href='/topic/show?id=316d1882bc' target=_blank style='color:#2F92EE;'>#ACS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1882, encryptionId=316d1882bc, topicName=ACS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=102a153, createdName=yaanren, createdTime=Sun Nov 24 03:19:00 CST 2013, time=2013-11-24, status=1, ipAttribution=)]
    2014-11-03 徐岩
  3. [GetPortalCommentsPageByObjectIdResponse(id=1851142, encodeId=cbe3185114284, 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=Thu Oct 30 22:19:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789101, encodeId=43141e8910129, content=<a href='/topic/show?id=34871434005' target=_blank style='color:#2F92EE;'>#PLA2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14340, encryptionId=34871434005, topicName=PLA2)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c2b4297, createdName=徐岩, createdTime=Mon Nov 03 06:19:00 CST 2014, time=2014-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995463, encodeId=c2b9199546335, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Jul 22 09:19:00 CST 2014, time=2014-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1669222, encodeId=e4b116692228f, content=<a href='/topic/show?id=561b1846324' target=_blank style='color:#2F92EE;'>#VISTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18463, encryptionId=561b1846324, topicName=VISTA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d46d26532205, createdName=muzishouyi, createdTime=Sun Mar 30 20:19:00 CST 2014, time=2014-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1279034, encodeId=ea9012e90342f, content=<a href='/topic/show?id=316d1882bc' target=_blank style='color:#2F92EE;'>#ACS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1882, encryptionId=316d1882bc, topicName=ACS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=102a153, createdName=yaanren, createdTime=Sun Nov 24 03:19:00 CST 2013, time=2013-11-24, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1851142, encodeId=cbe3185114284, 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=Thu Oct 30 22:19:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789101, encodeId=43141e8910129, content=<a href='/topic/show?id=34871434005' target=_blank style='color:#2F92EE;'>#PLA2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14340, encryptionId=34871434005, topicName=PLA2)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c2b4297, createdName=徐岩, createdTime=Mon Nov 03 06:19:00 CST 2014, time=2014-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995463, encodeId=c2b9199546335, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Jul 22 09:19:00 CST 2014, time=2014-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1669222, encodeId=e4b116692228f, content=<a href='/topic/show?id=561b1846324' target=_blank style='color:#2F92EE;'>#VISTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18463, encryptionId=561b1846324, topicName=VISTA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d46d26532205, createdName=muzishouyi, createdTime=Sun Mar 30 20:19:00 CST 2014, time=2014-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1279034, encodeId=ea9012e90342f, content=<a href='/topic/show?id=316d1882bc' target=_blank style='color:#2F92EE;'>#ACS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1882, encryptionId=316d1882bc, topicName=ACS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=102a153, createdName=yaanren, createdTime=Sun Nov 24 03:19:00 CST 2013, time=2013-11-24, status=1, ipAttribution=)]
    2014-03-30 muzishouyi
  5. [GetPortalCommentsPageByObjectIdResponse(id=1851142, encodeId=cbe3185114284, 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=Thu Oct 30 22:19:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789101, encodeId=43141e8910129, content=<a href='/topic/show?id=34871434005' target=_blank style='color:#2F92EE;'>#PLA2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14340, encryptionId=34871434005, topicName=PLA2)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c2b4297, createdName=徐岩, createdTime=Mon Nov 03 06:19:00 CST 2014, time=2014-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995463, encodeId=c2b9199546335, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Jul 22 09:19:00 CST 2014, time=2014-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1669222, encodeId=e4b116692228f, content=<a href='/topic/show?id=561b1846324' target=_blank style='color:#2F92EE;'>#VISTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18463, encryptionId=561b1846324, topicName=VISTA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d46d26532205, createdName=muzishouyi, createdTime=Sun Mar 30 20:19:00 CST 2014, time=2014-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1279034, encodeId=ea9012e90342f, content=<a href='/topic/show?id=316d1882bc' target=_blank style='color:#2F92EE;'>#ACS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1882, encryptionId=316d1882bc, topicName=ACS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=102a153, createdName=yaanren, createdTime=Sun Nov 24 03:19:00 CST 2013, time=2013-11-24, status=1, ipAttribution=)]
    2013-11-24 yaanren

相关资讯

AJC:高残余血小板活性的ACS患者预后差(VIP研究)

意大利一项研究表明,在接受经皮冠脉介入(PCI)和支架置入的急性冠脉综合征(ACS)患者中,约1/3表现为高残余血小板活性(HRPR)并且伴有较差预后,但抑制血小板水平与缺血或出血事件的发生不独立相关。论文于6月7日在线发表于《美国心脏病学杂志》(Am J Cardiol)。 此项研究共纳入833例接受PCI和支架置入的非ST段抬高型ACS患者,并PCI后30天进行血

EJEM:和肽素(copeptin)或可用作急性冠脉综合征的生物标记物

      科学家最近发现一种名为和肽素的物质可以作为急性冠脉综合症非常有效的生物标记物。通过和肽素监测,研究人员可以迅速确定患者是否为心脏病发作。一项有902人参与的临床研究显示,通过和肽素检测方法可以大大提高心脏病确诊的准确性。 一位英国的医生表示,在医院中有类似胸口疼痛等心脏病疑似症状的患者中大概只有10%真正患有急性心脏病。这一生物标记物如能应用,将大大提高医院工

Heart:吸烟影响氯吡格雷药效

  四川大学华西医院黄德嘉教授等评估了吸烟对氯吡格雷的临床和药效反应的影响。结果表明,吸烟似乎确实改变了相关临床疗效和氯吡格雷的药效,论文6月8日在线发表于《心脏》(Heart)杂志。   研究者检索了Medline,EMBASE和Cochrane图书馆。入选了那些记录主要心血管不良事件和通过吸烟状态进行分类的血小板对氯吡格雷反应性的临床和实验室试验。利用随机效应模型进行主要分析。对于临床研究,

赵水平:急性冠脉综合征如何调脂治疗?

中南大学湘雅二医院心血管内科  赵水平急 性冠状动脉综合征(ACS)患者特别是急性心肌梗死(AMI)患者,可因应激状态,基线血脂浓度有较大波动。AMI发生24h后,总胆固醇(TC)、低密 度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、载脂蛋白(apo)A1及apoB均有明显下降,而甘油三酯(TG)却增加;4~5d 后变化最为明显,2~3个月后可回到基线状态。此

我国心血管病诊疗将有法可依

5月25日上午,2013年度国家卫生和计划生育委员会“心血管疾病诊疗标准的制订与推广项目”讨论会在东方会期间举行。 该项目旨在通过建立心血管领域各病种(学科)诊断依据及规范的治疗操作规程,规范心血管病临床诊疗,优化治疗策略,规范医疗服务体系质量控制,加强监督评价,促进医疗质量总体提升。 中华医学会心血管病学分会主任委员霍勇教授在会上强调,“诊疗标准”不同于“临床指南”,它是由卫生计生委

Am Heart J:运动负荷成像模式可短期影响急性冠脉综合征患者转归

美国一项研究表明,在行经皮冠脉介入(PCI)的急性冠脉综合征患者中,与接受运动负荷核素显像的患者相比,超声心动图成像者的有创操作实施率较低,重复检查率较高,但上述差异持续时间有限。论文8月19日在线发表于《美国心脏杂志》(Am Heart J)。因急性冠脉综合征行PCI的患者往往实施运动负荷试验。此项纵向观察研究共纳入63,100例于PCI后3至15个月期间行负荷试验的患者,并对比了运动负荷超声心