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PCSK9抑制剂终于挺进英国!赛诺菲/安进降胆固醇药物 Praluent/Repatha同获NICE支持

2016-05-12 佚名 生物谷Bioon.com

英国医疗成本控制部门NICE(英国国家卫生与临床优化研究所)近日发布最新指南,推荐将赛诺菲的Praluent和安进的Repatha作为胆固醇代谢障碍患者的用药选择。 英国NICE建议原发性高血胆固醇或混合型血脂异常的成人患者在他汀类及其它药物不能够成功控制胆固醇水平的前提下,服用Praluent和Repatha,有助于降低患心血管疾病的风险。 Praluent(alirocumab)和Re

英国医疗成本控制部门NICE(英国国家卫生与临床优化研究所)近日发布最新指南,推荐将赛诺菲的Praluent和安进的Repatha作为胆固醇代谢障碍患者的用药选择。

英国NICE建议原发性高血胆固醇或混合型血脂异常的成人患者在他汀类及其它药物不能够成功控制胆固醇水平的前提下,服用Praluent和Repatha,有助于降低患心血管疾病的风险。

Praluent(alirocumab)和Repatha(evolocumab)都是PCSK9抑制剂,能够阻断PCSK9蛋白的功能,从而使得肝脏能够代谢血液中的胆固醇。有趣的是,最初赛诺菲和安进在NICE的审批过程中,都遭到了NICE的拒绝。

临床试验中,赛诺菲的Praluent能够大幅降低(与安慰剂相比下降百分比为62%)患者的低密度脂蛋白胆固醇水平(LDL-cholesterol,即所谓的“坏胆固醇”),而与默沙东的ezetimibe相比,用药后胆固醇水平下降了40%。而Repatha的临床试验数据也非常乐观,与安慰剂相比,患者的低密度脂蛋白胆固醇水平下降了55%-75%;而与ezetimibe相比,Repatha治疗组的胆固醇水平也下降了35%-45%。

NICE健康科技评估中心负责人Carole Longson MBE教授表示,Praluent(alirocumab)和Repatha(evolocumab)这两种PCSK9抑制剂和安慰剂/ezetimibe/他汀类药物相比,能够有效控制原发性高血胆固醇或混合型血脂异常的成人患者的胆固醇水平,因此NICE对这两款药物作出了积极的评价和推荐。同时,NICE也指出,这两款药物的价格较为昂贵。服用这两款药物的患者平均每年要花费4000英镑,而ezetemibe只需要350英镑。

因此NICE建议,从节约成本的角度考虑,高胆固醇症患者的首选药物是alirocumab和evolocumab等常规用药,只有当NHS和制药公司达成折扣协议,或者通过改变生活习惯或服用常规药物无法控制胆固醇水平的原发性高血胆固醇或混合型血脂异常的成人患者,才建议使用Praluent(alirocumab)和Repatha(evolocumab)这两种PCSK9抑制剂。

伯明翰市立医院的介入心脏病学专家Derek Connolly表示,心血管疾病仍然是当今造成患者死亡的最大杀手,而高胆固醇是造成心血管疾病的重要原因。有效降低患者的胆固醇水平,对于预防心肌梗死和中风非常重要,这两种意外事件都有可能造成患者死亡或残疾,这对于患者及其家庭而言无疑是非常沉重的负担。因此NICE的决策对高胆固醇血症患者而言是一个巨大的好消息。这也说明现在业内已经对服用PCSK9抑制剂形成了共识,这对于患者非常有利。

关于PCSK9抑制剂

PCSK9抑制剂是一类单抗药物,靶标是一种名为前蛋白转化酶枯草溶菌素9(PCSK9)的蛋白,该蛋白可降低肝脏从血液中清除低密度脂蛋白胆固醇(LDL-C)的能力,而LDL-C被公认为心血管疾病(CVD)的主要风险因子。PCSK9抑制剂提供了一种全新的治疗模式来对抗LDL-C,被视为他汀类(如Lipitor和Zocor)之后降脂领域取得的最大进步。在这一轮研发竞赛中,安进的Repatha(evolocumab)和赛诺菲/Regeneron的Praluent(alirocumab)处于领先地位。()

原始出处:

NICE backs Sanofi's Praluent' Amgen's Repatha for cholesterol disorder

 

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    2017-02-17 Tamikia
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    2017-04-26 jklm09
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    2016-10-05 FukaiBao
  4. [GetPortalCommentsPageByObjectIdResponse(id=1685579, encodeId=2db816855e9a2, content=<a href='/topic/show?id=a340138e48a' target=_blank style='color:#2F92EE;'>#PCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13874, encryptionId=a340138e48a, topicName=PCS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=173d28230918, createdName=Tamikia, createdTime=Fri Feb 17 22:57:00 CST 2017, time=2017-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851308, encodeId=886f185130870, 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=51, 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=Wed Apr 26 19:57:00 CST 2017, time=2017-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1777239, encodeId=dca61e7723916, content=<a href='/topic/show?id=678d5348a6' target=_blank style='color:#2F92EE;'>#Csk#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5348, encryptionId=678d5348a6, topicName=Csk)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=979839152460, createdName=FukaiBao, createdTime=Wed Oct 05 21:57:00 CST 2016, time=2016-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786847, encodeId=a8cc1e868475b, content=<a href='/topic/show?id=4c5b138824d' target=_blank style='color:#2F92EE;'>#PCSK9抑制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13882, encryptionId=4c5b138824d, topicName=PCSK9抑制)], attachment=null, authenticateStatus=null, createdAvatar=/img/user_icon.png, createdBy=1072181, createdName=wjywjy, createdTime=Thu Sep 08 22:57:00 CST 2016, time=2016-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1288927, encodeId=26f9128892eea, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1426644, encodeId=08891426644b2, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1541155, encodeId=cdf31541155cf, content=<a href='/topic/show?id=5c961e37307' target=_blank style='color:#2F92EE;'>#THA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17373, encryptionId=5c961e37307, topicName=THA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=615b13300589, createdName=1249842em13(暂无昵称), createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621264, encodeId=02a016212643e, content=<a href='/topic/show?id=bdf61532e21' target=_blank style='color:#2F92EE;'>#Repatha#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15327, encryptionId=bdf61532e21, topicName=Repatha)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d4f620230812, createdName=mei538, createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1685579, encodeId=2db816855e9a2, content=<a href='/topic/show?id=a340138e48a' target=_blank style='color:#2F92EE;'>#PCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13874, encryptionId=a340138e48a, topicName=PCS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=173d28230918, createdName=Tamikia, createdTime=Fri Feb 17 22:57:00 CST 2017, time=2017-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851308, encodeId=886f185130870, 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=51, 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=Wed Apr 26 19:57:00 CST 2017, time=2017-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1777239, encodeId=dca61e7723916, content=<a href='/topic/show?id=678d5348a6' target=_blank style='color:#2F92EE;'>#Csk#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5348, encryptionId=678d5348a6, topicName=Csk)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=979839152460, createdName=FukaiBao, createdTime=Wed Oct 05 21:57:00 CST 2016, time=2016-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786847, encodeId=a8cc1e868475b, content=<a href='/topic/show?id=4c5b138824d' target=_blank style='color:#2F92EE;'>#PCSK9抑制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13882, encryptionId=4c5b138824d, topicName=PCSK9抑制)], attachment=null, authenticateStatus=null, createdAvatar=/img/user_icon.png, createdBy=1072181, createdName=wjywjy, createdTime=Thu Sep 08 22:57:00 CST 2016, time=2016-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1288927, encodeId=26f9128892eea, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1426644, encodeId=08891426644b2, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1541155, encodeId=cdf31541155cf, content=<a href='/topic/show?id=5c961e37307' target=_blank style='color:#2F92EE;'>#THA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17373, encryptionId=5c961e37307, topicName=THA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=615b13300589, createdName=1249842em13(暂无昵称), createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621264, encodeId=02a016212643e, content=<a href='/topic/show?id=bdf61532e21' target=_blank style='color:#2F92EE;'>#Repatha#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15327, encryptionId=bdf61532e21, topicName=Repatha)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d4f620230812, createdName=mei538, createdTime=Sat May 14 02:57:00 CST 2016, time=2016-05-14, status=1, ipAttribution=)]
    2016-05-14 fusion
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    2016-05-14 gwc384
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    2016-05-14 mei538

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