Nat Med:2型糖尿病患者皮下注射艾塞那肽与心血管结局

2021-12-07 网络 网络

对于患有或伴有ASCVD风险的2型糖尿病,ITCA650治疗并不劣于安慰剂。需要进行更大型、持续时间更长的心血管结局试验,以更准确地定义ITCA650在该人群中的心血管效应。

定期注射胰高血糖素样肽1受体激动剂(GLP-1RA)已被证明不会增加,并且对于某些心血管疾病患者可能会降低其心血管事件的风险。持续皮下输注GLP-1RA艾塞那肽(ITCA650)的心血管安全性尚未明确。

近日,顶级医学期刊Nature Medicine上发表了一篇研究文章,研究人员随机分配患有动脉粥样硬化性心血管疾病(ASCVD)或有患动脉粥样硬化性心血管疾病(ASCVD)风险的2型糖尿病患者接受ITCA650或安慰剂治疗,并在这项预批准试验(NCT01455896)中评估了其心血管安全性。

该研究的主要结局是心血管死亡、非致命性心肌梗死、非致命性卒中或因不稳定心绞痛住院的复合结局。根据美国食品和药物管理局2008年指南,研究人员使用了1.8的非劣效边际作为风险比(HR)的95%置信区间(CI)的上限。

研究人员将4156名患者(2075名被分配接受ITCA650治疗和2081名被分配接受安慰剂治疗)随机分组,随访中位时间为16个月。ITCA650组4.6%(95/2075)患者和安慰剂组3.8%(79/2081)患者出现了主要结局,符合预先指定的非劣效性标准(HR=1.21,95%CI为0.90-1.63,非劣效性P=0.004)。两组之间的严重不良事件相似。ITCA650组的不良事件(72%,1491/2074)比安慰剂组(63.9%,1325/2070)更频繁,主要是由于在使用ITCA650治疗期间胃肠道事件和疾病增加。

由此可见,对于患有或伴有ASCVD风险的2型糖尿病,ITCA650治疗并不劣于安慰剂。需要进行更大型、持续时间更长的心血管结局试验,以更准确地定义ITCA650在该人群中的心血管效应。

原始出处:

Christian T. Ruff,et al.Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial.Nature Medicine.2021.https://www.nature.com/articles/s41591-021-01584-3

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    2022-08-17 liye789132251
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    2021-12-10 智慧药

    学习学习

    0

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  8. 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09:10:35 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1077981, encodeId=00fa10e798142, content=学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=49de6390371, createdName=ms6000002040829062, createdTime=Wed Dec 08 08:02:59 CST 2021, time=2021-12-08, status=1, ipAttribution=)]
    2021-12-09 zhaojie88
  9. 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    2021-12-09 智慧药

    学习学习

    0

  10. 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    2021-12-08 ms6000002040829062

    学到了

    0

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与健康人相比,1型糖尿病患者骨折风险增加3倍,其中髋部骨折风险增加近4倍,死亡率也随之增加。而风险可能取决于血糖控制,独立年龄和性别。1型糖尿病髋部骨折风险增加的部分原因是骨密度降低。

Diabetologia:艾塞那肽注射液PB-119可有效治疗未治疗过的2型糖尿病

胰高血糖素样肽1受体激动剂,如艾塞那肽,可作为维持2型糖尿病患者血糖控制的单一疗法和附加疗法。PB-119,是一种聚乙二醇化的艾塞那肽注射液,治疗2型糖尿病的疗效如何?

Pediatr Obes:每周使用艾塞那肽可有效且安全的治疗青少年严重肥胖症

青少年肥胖症患者的药物治疗选择非常有限。胰高血糖素样肽-1(GLP-1)受体激动剂可以作为青少年肥胖症的治疗选择。近日,研究人员进行了一项为期6个月的随机、双盲、平行、安慰剂对照的临床试验,研究了艾塞

Lancet Diabetes Endo:艾塞那肽不能作为I型糖尿病患者胰岛素治疗的辅助治疗手段

研究认为,醋酸艾塞那肽作为I型糖尿病患者胰岛素治疗的辅助治疗效果不理想