NEJM:超重或肥胖患者每周应用一次索玛鲁肽的效果(STEP 1试验)

2021-02-11 MedSci原创 MedSci原创

导语:过年了,少吃一点。

导语:过年了,少吃一点。

肥胖是一种慢性疾病,也是全球公共卫生的挑战。 肥胖会导致胰岛素抵抗,高血压和血脂异常,带来伴有例如2型糖尿病血管疾病和非酒精性脂肪肝等的并发症,相应的也会缩短寿命。 最近的研究指向,肥胖或与新冠患者中与住院人数增加,机械通气需求增大以及死亡率的升高有关。

尽管生活方式干预(饮食和锻炼)是控制体重的基石,但长期保持体重仍然是一项艰巨的任务。 临床指南建议进行药物辅助治疗,特别是对于身体质量指数(BMI)超过30的成年人,或BMI超过27的伴并发症患者。 但是,可用药物的使用仍然受到效果,安全性和成本的限制。

索马鲁肽是一种已获批准的胰高血糖素样肽1(GLP-1)类似物,每周一次1mg皮下给药,可用于治疗成人2型糖尿病并降低2型糖尿病和心血管疾病患者发生心血管事件的风险。索玛鲁肽成功使得参加2期试验的2型糖尿病患者和肥胖成人的体重减轻,这些发现支持研究人员进行进一步的研究。 全球3期索玛鲁肽在肥胖症患者中的治疗效果(STEP)计划旨在评估在体重超重或肥胖,伴或不伴体重相关并发症的人群中,每周一次2.4mg剂量皮下注射的疗效和安全性。

这项为期68周的试验评估了索玛鲁肽与安慰剂的有效性和安全性(作为生活方式干预的辅助手段),这些干预措施可减轻体重过重或肥胖且无糖尿病的成年人的体重并达到其他相关终点。

在这项双盲试验中,我们招募了1961名成年受试者,均非糖尿病患者。他们的BMI至少为30(若他们存在超过一种与体重过重相关的疾病,则只要求BMI超过27),并按2:1的比例将其随机分配至两组,除生活方式干预外,一组每周一次皮下注射索玛鲁肽(剂量为2.4 mg),一组注射安慰剂,共治疗68周。 主要终点是体重的百分比变化和体重减轻至少5%。

索玛鲁肽组从基线到第68周的平均体重变化为-14.9%,而安慰剂为-2.4%,估计治疗差异为-12.4个百分点(95%置信区间[CI],-13.4  -11.5; P <0.001)。  在68周时,索玛鲁肽组与安慰剂组相比,体重减轻超过5%的人数分别为1047人[86.4%]与182 [31.5%],体重减轻超过10%的人数为分别为838人人 [69.1%]与69 [12.0%],超过15%的人数分别为612 人[50.5%] 与28人 [4.9%],(所有三项赔率比较,P <0.001)。索玛鲁肽组从基线到第68周的体重变化为-15.3 kg,而安慰剂组为-2.6 kg(估计治疗差异为-12.7 kg; 95%置信区间[CI]为-13.7至-11.7)。与服用安慰剂的受试者相比,接受索玛鲁肽治疗的受试者在心血管代谢危险因素方面的改善更大,并且参与者报告的身体功能从基线开始的增加更强。索玛鲁肽最常见的不良反应是恶心和腹泻。 他们通常是短暂的,轻度至中度,并随着时间消退。索玛鲁肽组因胃肠道事件而终止治疗的人数(59人 [4.5%]) 要多于安慰剂组(5 人[0.8%])。

实验结果表明,在超重或肥胖的参与者中,每周一次2.4mg的索玛鲁肽加上生活方式干预与持续,能够有效减轻体重。

相关信息:

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索马鲁肽治疗阿尔茨海默病!诺和诺德直接启动3700人IIIa期试验

JCEM:索马鲁肽对囊性纤维化相关性糖尿病的疗效分析

NEJM:利拉鲁肽治疗青少年肥胖

原始出处:

John P.H. Wilding, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. NEJM, DOI: 10.1056/NEJMoa2032183

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    2021-03-03 carrotlyl

    新颖研究

    0

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    2021-02-13 carrotlyl

    感谢分享

    0

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    2021-02-11 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1951027, encodeId=88df195102ea3, content=<a href='/topic/show?id=72078190803' target=_blank style='color:#2F92EE;'>#肥胖患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81908, encryptionId=72078190803, topicName=肥胖患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28b7142, createdName=liuquan, createdTime=Wed Mar 31 07:20:37 CST 2021, time=2021-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1974230, encodeId=a54a19e42309b, content=<a href='/topic/show?id=bcbe9293912' target=_blank style='color:#2F92EE;'>#超重或肥胖#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92939, encryptionId=bcbe9293912, topicName=超重或肥胖)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/3239AC2A9C7E6019A0BC3C0489A21F7A/100, createdBy=c6a52500178, createdName=41514487@qq.com, createdTime=Mon Jun 21 01:20:37 CST 2021, time=2021-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=945014, encodeId=d75b9450143e, content=新颖研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210127/50a003c4097845e182c08afd64d8a509/bd766dfebe9c40e0bca2dae964601bdc.jpg, createdBy=22de5454917, createdName=carrotlyl, createdTime=Wed Mar 03 06:44:26 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924393, encodeId=e34c9243932e, content=感谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210127/50a003c4097845e182c08afd64d8a509/bd766dfebe9c40e0bca2dae964601bdc.jpg, createdBy=22de5454917, createdName=carrotlyl, createdTime=Sat Feb 13 08:20:55 CST 2021, time=2021-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035569, encodeId=8d4c103556907, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Feb 11 12:20:37 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047275, encodeId=9013104e2754a, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Thu Feb 11 12:20:37 CST 2021, time=2021-02-11, status=1, ipAttribution=)]
    2021-02-11 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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