ADA 2018:度拉糖肽治疗的糖尿病患者真实世界研究数据公布!

2018-07-04 MedSci MedSci

近日,真实世界数据显示,对于首次接受胰高血糖素样肽-1(GLP-1)受体激动剂(RA)治疗的2型糖尿病患者,接受每周一次Trulicity®(度拉糖肽)治疗相比于接受每日一次利拉鲁肽和每周一次(QW)艾塞那肽治疗可以获得更好的血糖控制,依从性更好及坚持治疗的时间更长1, 2。这些数据在奥兰多举行的第78届美国糖尿病协会(ADA)科学年会上进行首次披露。Trulicity®(度拉糖肽)是礼来公司于2

近日,真实世界数据显示,对于首次接受胰高血糖素样肽-1(GLP-1)受体激动剂(RA)治疗的2型糖尿病患者,接受每周一次Trulicity®(度拉糖肽)治疗相比于接受每日一次利拉鲁肽和每周一次(QW)艾塞那肽治疗可以获得更好的血糖控制,依从性更好及坚持治疗的时间更长1, 2。这些数据在奥兰多举行的第78届美国糖尿病协会(ADA)科学年会上进行首次披露。

Trulicity®(度拉糖肽)是礼来公司于2014年在美国获批,用于改善成人2型糖尿病患者血糖的注射用GLP-1 RA周制剂,现有的规格包括0.75mg和1.5mg,该药应同时配合饮食和运动治疗。

来自HealthCore公司的副总监兼主要研究者Huang Qing博士表示:“我们知道,2型糖尿病患者如果能够依从处方用药,那么血糖会得到更好的控制。然而,我们发现,让患者保持良好的治疗依从性始终是一项挑战。这些真实世界数据显示,人们接受每周一次Trulicity®(度拉糖肽)治疗相比于接受其他两种GLP-1 RA治疗依从性更好且达到更低的A1C水平。”

这项回顾性观察研究基于在美国接受新处方Trulicity®(度拉糖肽)、利拉鲁肽或艾塞那肽QW的2型糖尿病患者的保险赔付数据,其目的是比较这些治疗在真实世界中的表现1,2。对患者进行特征匹配,如年龄、性别、地点和基线A1C水平以确保组间平衡。结果表明包括A1C降幅、依从性(按处方用药)和持续性(接受治疗的持续时间)在内的所有指标一致显示Trulicity®(度拉糖肽)更具优势1,2。

经过6个月和1年治疗后,Trulicity®(度拉糖肽)的降糖效果均显著优于利拉鲁肽(A1C的平均绝对降幅,%):

6个月:-1.10%(Trulicity®度拉糖肽),-0.86%(利拉鲁肽)

1年:-0.98%(Trulicity®度拉糖肽),-0.77%(利拉鲁肽)

经过6个月和1年治疗后,和艾塞纳肽QW 比较,Trulicity®(度拉糖肽)显示出了明显更好的降糖效果趋势 (A1C平均绝对降幅,%):

6个月:-1.15%(Trulicity®度拉糖肽),-0.92%(艾塞那肽QW)

1年:-1.00%(Trulicity®度拉糖肽),-0.77%(艾塞那肽QW)

与接受利拉鲁肽或艾塞那肽QW治疗的患者相比,接受Trulicity®(度拉糖肽)治疗的患者在1年之后更可能依从治疗方案且较少中止治疗。接受Trulicity®(度拉糖肽)治疗的患者中止治疗的比例显著低于接受利拉鲁肽或艾塞那肽QW治疗的患者。

Trulicity®(度拉糖肽)vs.利拉鲁肽

依从性:51.2%(Trulicity®度拉糖肽),38.2%(利拉鲁肽)
持续性:252.8天(Trulicity®度拉糖肽),218.2天(利拉鲁肽)
中止治疗的患者:45.0%(Trulicity®度拉糖肽),56.2%(利拉鲁肽)

Trulicity®(度拉糖肽)vs.艾塞那肽QW

依从性:50.7%(Trulicity®度拉糖肽),31.9%(艾塞那肽QW)
持续性:251.4天(Trulicity®度拉糖肽),192.5天(艾塞那肽QW)
中止治疗的患者:45.1%(Trulicity®度拉糖肽),65.6%(艾塞那肽QW)

礼来糖尿病医学总监医学博士Laura Fernández Landó表示:“每周给药一次的Trulicity®(度拉糖肽)旨在帮助2型糖尿病患者通过一种简单的方式过渡到注射治疗,并达到其A1C目标”。她还指出:“这些真实世界研究结果包括Trulicity®(度拉糖肽)的一年随访数据,结果显示,Trulicity®(度拉糖肽)对于首次接受GLP-1 RA治疗的患者来说更容易坚持治疗”。

这项真实世界观察性研究使用了来自HealthCore综合研究数据库(HIRD®)2014年11月至2016年5月的美国保险赔付数据,旨在比较首次接受Trulicity®(度拉糖肽)(1.5mg和0.75mg)、利拉鲁肽(1.8mg和0.6/1.2mg)和艾塞纳肽QW治疗2型糖尿病患者的降糖疗效(6个月和1年)。对于Trulicity®(度拉糖肽)与利拉鲁肽的比较,分别有41%患者和59%患者接受Trulicity®(度拉糖肽)1.5mg和0.75mg治疗,分别有56%患者和44%患者接受利拉鲁肽1.8mg和1.2mg治疗。该研究也对接受Trulicity®(度拉糖肽)、利拉鲁肽和艾塞那肽QW治疗的患者为期1年的依从性和持续性进行了比较。研究中的患者为18岁及以上成年人,并且在不同组间按基线A1C、年龄、性别和地点等特征进行匹配。

度拉糖肽已在中国递交上市申请,并已进入药审中心优先审评,目前还未上市。

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研究者对2型糖尿病患者进行了一项研究,比较糖尿病药物度拉糖肽每周一次0.75mg单药治疗与利拉鲁肽每天0.9mg的有效性和安全性。该Ⅲ期随机对照试验长达52周时间,共纳入492名患者,其中度拉糖肽组281人,利拉鲁肽141人,安慰剂组70人。首先参与者和调查者对度拉糖肽和安慰剂组是盲法,但对利拉鲁肽是非盲,26周后安慰剂组开始使用度拉糖肽每周0.75mg。研究数据显示,治疗第52周患者HbA1c下

Lancet diabetes endo:度拉糖肽作为SGLT2抑制剂的补充治疗,用于血糖控制效果欠佳的2型糖尿病患者的效果和安全性

GLP-1受体兴奋剂和钠-葡萄糖共转运体-2(SGLT2)抑制剂可通过不同的机制改善2型糖尿病患者的血糖控制,并减轻其体重。近日,Lancet子刊上发表一篇文章,对采用SGLT2抑制剂治疗(联合或未联合二甲双胍)未能很好的控制血糖的2型糖尿病患者,每周补充一次GLP-1受体兴奋剂度拉糖肽(dulaglutide)的疗效和安全性进行评估。研究人员在多个国家的40个临床中心进行一双盲、平行臂、安慰剂为