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网状荟萃分析准确预测了随后一项比较每周一次度拉糖肽1.5毫克和每日一次利拉鲁肽1.8毫克的随机试验的结果。

Network meta-analysis accurately predicted the outcome of a subsequent randomised trial comparing once weekly dulaglutide 1.5 mg and once daily liraglutide 1.8 mg.

作者信息

Fahrbach J L, Fu H, Shurzinske L, Skrivanek Z, Martin S

机构信息

Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN, USA.

出版信息

Int J Clin Pract. 2016 Mar;70(3):218-21. doi: 10.1111/ijcp.12775. Epub 2016 Feb 24.

Abstract

BACKGROUND

Glucagon-like peptide-1 (GLP-1) receptor agonists are an established treatment for people with type 2 diabetes (T2D). We aimed to indirectly compare two GLP-1 receptor agonists, once weekly dulaglutide 1.5 mg and once daily liraglutide 1.8 mg, as a part of clinical trial planning.

METHODS

Studies for inclusion in the network meta-analysis (NMA) included all available dulaglutide and liraglutide data as of November 2011 as well as results from the exenatide once weekly registration programme. Change from baseline in haemoglobin A1c (A1c) was the primary endpoint, and a 26-week treatment effect was estimated.

RESULTS

Data for 7135 people with T2D from 15 randomised controlled trials (RCTs) followed for 12-52 weeks were included in the quantitative analysis. Observed results from the NMA predicted an A1c change from baseline of -15.1 mmol/mol (-1.38%) in the dulaglutide 1.5 mg group and -14.7 mmol/mol (-1.34%) in the liraglutide 1.8 mg group, with a predicted treatment difference (dulaglutide-liraglutide) of -0.4 mmol/mol (-0.04%) [95% credible interval: -2.4 to 1.5 mmol/mol (-0.22% to 0.14%)].

CONCLUSIONS

The subsequent RCT primary result of a -0.7 mmol/mol (-0.06%) treatment difference (dulaglutide-liraglutide) in A1c demonstrated that once weekly dulaglutide 1.5 mg and once daily liraglutide 1.8 mg resulted in similar glycaemic control, which was consistent with the NMA-predicted treatment difference. NMA is a useful tool and should be considered during clinical trial planning.

摘要

背景

胰高血糖素样肽-1(GLP-1)受体激动剂是2型糖尿病(T2D)患者的一种既定治疗方法。作为临床试验规划的一部分,我们旨在间接比较两种GLP-1受体激动剂,即每周一次的度拉糖肽1.5毫克和每日一次的利拉鲁肽1.8毫克。

方法

纳入网络荟萃分析(NMA)的研究包括截至2011年11月所有可用的度拉糖肽和利拉鲁肽数据,以及艾塞那肽每周一次注册项目的结果。糖化血红蛋白(A1c)相对于基线的变化是主要终点,并估计了26周的治疗效果。

结果

15项随机对照试验(RCT)中7135例T2D患者的数据被纳入定量分析,这些试验随访了12至52周。NMA的观察结果预测,度拉糖肽1.5毫克组A1c相对于基线的变化为-15.1 mmol/mol(-1.38%),利拉鲁肽1.8毫克组为-14.7 mmol/mol(-1.34%),预测的治疗差异(度拉糖肽-利拉鲁肽)为-0.4 mmol/mol(-0.04%)[95%可信区间:-2.4至1.5 mmol/mol(-0.22%至0.14%)]。

结论

随后RCT的主要结果显示,度拉糖肽1.5毫克每周一次和利拉鲁肽1.8毫克每日一次在A1c方面的治疗差异为-0.7 mmol/mol(-0.06%),表明二者在血糖控制方面效果相似,这与NMA预测的治疗差异一致。NMA是一种有用的工具,在临床试验规划过程中应予以考虑。

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