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Diabetes Obes Metab:利拉鲁肽与口服降糖药作为附加疗法在单独使用二甲双胍的2型糖尿病患者中维持血糖控制

2021-11-13 从医路漫漫 MedSci原创

由于大多数2型糖尿病(T2D)患者是在初级保健中接受治疗的,初级保健临床医生在优化糖尿病管理方面发挥着关键作用。血糖控制的改善和保持与更强的降糖治疗依从性有关,长期保持良好的血糖控制可降低T2D并发症

由于大多数2型糖尿病(T2D)患者是在初级保健中接受治疗的,初级保健临床医生在优化糖尿病管理方面发挥着关键作用。血糖控制的改善和保持与更强的降糖治疗依从性有关,长期保持良好的血糖控制可降低T2D并发症的风险。美国糖尿病协会(ADA)和欧洲糖尿病研究协会指南推荐二甲双胍作为T2D患者的一线药物治疗。一线药物治疗失败后强化治疗的药物选择包括胰高血糖素样肽-1受体激动剂(GLP-1 RA)、葡萄糖钠共转运体-2抑制剂(SGLT-2i)、二肽基肽酶-4抑制剂(DPP-4i)、磺脲类(SU)、噻唑烷二酮和基础胰岛素。或者联合降糖治疗。选择应基于药物特异性作用和患者特征,如动脉粥样硬化性心血管事件或低血糖的风险,减肥的需要,以及成本。本研究的目的是比较利拉鲁肽与口服降糖药物(OAD)在单用二甲双胍的血糖未控制的2型糖尿病(T2D)患者中控制血糖的效果。

方法:18岁或以上T2D (HbA1c 7.5%-9.0% [58.5-74.9 mmol/mol])的患者在筛查前接受稳定剂量的二甲双胍(≥1500 mg/d或最大耐受剂量)单药治疗60天或更长时间,并符合利拉鲁肽和OAD治疗的当地标准,即符合条件。12例孕妇或哺乳期患者,以及筛查前60天或更短时间内接受二甲双胍以外的任何糖尿病药物治疗的患者被排除在外。在2周或更短的筛选期后,患者被随机(1:1)皮下注射利拉鲁肽或OAD (α-葡萄糖苷酶抑制剂,DPP-4i,美格列酮,SGLT-2i, SU或噻唑烷二酮),两者都加入二甲双胍,持续104周。分配的OAD是由研究者选择的,因此不属于随机化过程的一部分。利拉鲁肽的剂量从0.6 mg/d增加到1.2 mg/d,最终剂量为1.8 mg/d。OAD剂量增加到批准/耐受的最大剂量。对于利拉鲁肽和OADs,如果患者的HbA1c低于7.0%,维持低于批准的最大剂量/耐受剂量是可以的。在整个治疗期间,二甲双胍维持在试验前的剂量和用药频率,除非存在安全性问题。随访安排在随机分组后的第2、4、16和26周,此后每季度进行一次,以反映常规实践中的正常随访频率。治疗结束后随访1周。

主要终点:第26周后两次预定连续随访至血糖控制不充分(HbA1c > 7.0%)的时间。分别评估了利拉鲁肽与混合OAD组以及(事后)利拉鲁肽与钠-葡萄糖共转运体-2抑制剂、二肽基肽酶-4抑制剂和磺脲类药物的疗效。

结果:在随机分组的患者(利拉鲁肽,n=996;OAD,n=995)中,47.6%的患者为女性,平均年龄为57.4岁,平均糖化血红蛋白(HbA1c)为8.2%。使用利拉鲁肽的患者血糖控制不佳的中位时间比OAD为44周(109周[25%百分位数,38;75%百分位数]和65周[25%百分位数,35;75%百分位数,107],P<0.0001)。在104周或过早停止治疗的患者中,使用利拉鲁肽比使用OAD的患者糖化血红蛋白和体重变化更明显。两组间低血糖发生率相似,很少有患者因不良事件而停用(利拉鲁肽,7.9%[n=79])。

图1 OAD,4.1%[n=41])。在利拉鲁肽与单独的OAD事后分析中也观察到了类似的结果。利拉鲁肽与OAD治疗至血糖控制不足的时间的Kaplan-Meier图*。*OADs包括研究人员选择的药物类别:α-葡萄糖苷酶抑制剂、二肽基肽酶-4抑制剂、钠-葡萄糖共转运体-2抑制剂、磺脲类或噻唑烷二酮;利拉鲁肽和OADs与二甲双胍联合使用。全分析集。血糖控制不充分的主要时间终点被定义为在治疗前26周至104周后连续两次预定随访时HbA1c > 7.0% (>53 mmol/mol)。第一次可能发生在第38周。无处理差异的检验基于对区间截尾失效时间数据的广义对数秩检验。OAD,口服降糖药

表1 利拉鲁肽与OADa治疗的时间和过早停止治疗的时间

表2 在第104周或过早停止治疗时,临床变量与基线的变化

表3 治疗紧急严重不良事件(SOC和发生在任何组≥1%的患者)

图2 利拉鲁肽治疗至血糖控制不充分与事后OAD亚组的Kaplan-Meier时间图*。*OADs包括研究人员选择的药物类别:α-葡萄糖苷酶抑制剂、DPP-4i、SGLT-2i、SU或噻唑烷二酮;利拉鲁肽和OADs与二甲双胍联合使用。全分析集。血糖控制不充分的主要时间终点被定义为在治疗前26周至104周后连续两次预定随访时HbA1c > 7.0% (>53 mmol/mol)。第一次可能发生在第38周。无处理差异的检验基于对区间截尾失效时间数据的广义对数秩检验。二肽基肽酶-4抑制剂DPP-4i;SGLT-2i,钠-葡萄糖共转运体-2抑制剂;SU,磺脲类

结论:与OAD相比,利拉鲁肽能更好地维持血糖控制,支持在T2D患者强化治疗时使用利拉鲁肽。

原文出处:

 Unger J,  Allison DC,  Kaltoft M,et al.Maintenance of Glycemic Control with Liraglutide versus Oral Antidiabetic Drugs as Add-on Therapies in Patients with Type 2 Diabetes Uncontrolled with Metformin Alone: A Randomized Clinical Trial in Primary Care (LIRA-PRIME).Diabetes Obes Metab 2021 Oct 07

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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a44885671, createdName=419040982, createdTime=Tue Nov 16 22:45:13 CST 2021, time=2021-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270932, encodeId=47a312e09324a, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=127, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273053, encodeId=120712e30534c, content=<a href='/topic/show?id=2f468983351' target=_blank style='color:#2F92EE;'>#血糖控制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89833, encryptionId=2f468983351, topicName=血糖控制)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef84111, createdName=whlxd, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1312778, encodeId=7bd61312e7804, content=<a href='/topic/show?id=59af3824946' target=_blank style='color:#2F92EE;'>#口服降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38249, encryptionId=59af3824946, topicName=口服降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=49ef408, createdName=hunizi005, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1383736, encodeId=858c1383e3697, content=<a href='/topic/show?id=196a1101f7' target=_blank style='color:#2F92EE;'>#2型糖尿病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1101, encryptionId=196a1101f7, topicName=2型糖尿病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec19483, createdName=aids213, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=)]
    2022-07-24 guojianrong
  4. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a44885671, createdName=419040982, createdTime=Tue Nov 16 22:45:13 CST 2021, time=2021-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270932, encodeId=47a312e09324a, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=127, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273053, encodeId=120712e30534c, content=<a href='/topic/show?id=2f468983351' target=_blank style='color:#2F92EE;'>#血糖控制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89833, encryptionId=2f468983351, topicName=血糖控制)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef84111, createdName=whlxd, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1312778, encodeId=7bd61312e7804, content=<a href='/topic/show?id=59af3824946' target=_blank style='color:#2F92EE;'>#口服降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38249, encryptionId=59af3824946, topicName=口服降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=49ef408, createdName=hunizi005, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1383736, encodeId=858c1383e3697, content=<a href='/topic/show?id=196a1101f7' target=_blank style='color:#2F92EE;'>#2型糖尿病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1101, encryptionId=196a1101f7, topicName=2型糖尿病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec19483, createdName=aids213, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=)]
    2022-09-06 一闲
  5. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a44885671, createdName=419040982, createdTime=Tue Nov 16 22:45:13 CST 2021, time=2021-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270932, encodeId=47a312e09324a, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=127, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273053, encodeId=120712e30534c, content=<a href='/topic/show?id=2f468983351' target=_blank style='color:#2F92EE;'>#血糖控制#</a>, beContent=null, objectType=article, 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  6. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a44885671, createdName=419040982, createdTime=Tue Nov 16 22:45:13 CST 2021, time=2021-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270932, encodeId=47a312e09324a, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=127, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273053, encodeId=120712e30534c, content=<a href='/topic/show?id=2f468983351' target=_blank style='color:#2F92EE;'>#血糖控制#</a>, beContent=null, objectType=article, 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href='/topic/show?id=196a1101f7' target=_blank style='color:#2F92EE;'>#2型糖尿病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1101, encryptionId=196a1101f7, topicName=2型糖尿病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec19483, createdName=aids213, createdTime=Mon Nov 15 04:13:44 CST 2021, time=2021-11-15, status=1, ipAttribution=)]
    2021-11-16 419040982

    好的!

    0

  7. 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  9. 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结合运动和利拉鲁肽治疗的策略更能改善健康的减肥维持。

Antioxidants:GLP-1类似物利拉鲁肽通过减少氧化应激和炎症改善脓毒血症影响的血管功能

利拉鲁肽是一种长效胰高血糖素样肽-1 (GLP-1)的类似物,在食物摄取后释放,参与葡萄糖的调节。

Diabetes Obes Metab:利拉鲁肽可减少2型糖尿病患者心脏脂肪量

利拉鲁肽治疗26周后可减少心脏脂肪组织。心脏脂肪组织减少与体重减轻无关,表明这不是药物特异性作用。

Lancet子刊:“明星药”利拉鲁肽对超重和肥胖成人内脏脂肪的影响

对于已发生糖尿病及冠心病的胖人而言,减轻体重,改善胰岛素敏感性,是治疗的基础。

2021年美国内分泌年会速递:老药新用,利拉鲁肽,减肥新希望

利拉鲁肽(Liraglutide)可改善与遗传性肥胖患者的体重、代谢参数和生活质量。

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