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度拉糖肽每周一次与胰岛素每周一次治疗2型糖尿病的疗效和安全性比较:一项随机临床试验的网状Meta分析

Comparative efficacy and safety of weekly dulaglutide versus weekly insulin in type 2 diabetes: A network meta-analysis of randomized clinical trials.

作者信息

Ayesh Hazem, Suhail Sajida, Ayesh Suhail, Niswender Kevin

机构信息

Department of Medicine, Division of Diabetes, Endocrinology, and Metabolism, Vanderbilt University Medical Center, Nashville, TN, USA.

Gene Medical Labs, Gaza, Palestine.

出版信息

Metabol Open. 2024 Apr 23;22:100284. doi: 10.1016/j.metop.2024.100284. eCollection 2024 Jun.

DOI:10.1016/j.metop.2024.100284
PMID:38699397
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11064603/
Abstract

BACKGROUND

Advancements in type 2 diabetes mellitus (T2DM) therapy, notably with weekly agents like glucagon-like peptide-1 receptor agonists (GLP-RAs) such as dulaglutide, offer promising outcomes in clinical practice. The emergence of once-weekly insulin adds to this therapeutic arsenal. This research aims to explore and compare the efficacy and safety profiles of these agents in diabetes management, facilitating informed decision-making for optimizing their utilization in clinical practice.

METHODS

A systematic search of PubMed, Scopus, Cochrane, and Web of Science databases was conducted. The research protocol was registered at OSF registries (https://osf.io/gd67x). The primary outcome of interest was the change in hemoglobin A1C (HbA1c), with secondary outcomes including the change in fasting plasma glucose, body weight, prevalence of hypoglycemia, and treatment discontinuation due to adverse events. The evaluation of bias risk was conducted utilizing the RoB2 tool developed by the Cochrane Collaboration. Statistical analysis was performed using RStudio version 4.3.2 with the meta package version 7.0-0 and the netmeta package version 2.9-0. Confidence in network meta-analysis estimates was evaluated using the CINeMA (Confidence In Network Meta-Analysis). Heterogeneity was assessed by comparing the magnitude of the common between-study variance (τ2) for each outcome with empirical distributions of heterogeneity variances.

RESULTS

Dulaglutide 1.5 mg (mg) weekly demonstrated superior reduction in hemoglobin A1C (HbA1c) compared to insulin, with a mean difference (MD) of -0.35 (95 % CI: -0.51 to -0.19). Additionally, Dulaglutide 1.5 mg exhibited greater weight loss, with an MD of -3.12 (95 % CI: -3.55 to -2.68). However, it also showed a higher rate of adverse events, with an odds ratio (OR) of 1.40 (95 % CI: 1.12 to 1.75) compared to insulin. Both doses of Dulaglutide (1.5 mg and 0.75 mg) had lower prevalence of hypoglycemia compared to insulin, with ORs of 0.60 (95 % CI: 0.41 to 0.87) and 0.59 (95 % CI: 0.41 to 0.86), respectively. There was no significant difference in treatment discontinuation among the treatment groups.

CONCLUSION

Dulaglutide, particularly at higher doses, demonstrates superior efficacy in lowering hemoglobin A1C and reducing hypoglycemia risk compared to Icodec insulin in type 2 diabetes management. However, its use is also associated with a higher incidence of adverse events. Clinicians should carefully consider these factors when selecting optimal treatment strategies for patients with type 2 diabetes mellitus.

摘要

背景

2型糖尿病(T2DM)治疗取得了进展,特别是使用如度拉糖肽等胰高血糖素样肽-1受体激动剂(GLP-RAs)这类每周一次给药的药物,在临床实践中带来了有前景的治疗效果。每周一次注射的胰岛素的出现进一步丰富了这一治疗手段。本研究旨在探索和比较这些药物在糖尿病管理中的疗效和安全性,为在临床实践中优化其使用提供依据,以便做出明智的决策。

方法

对PubMed、Scopus、Cochrane和Web of Science数据库进行了系统检索。研究方案已在OSF注册库(https://osf.io/gd67x)登记。主要关注的结局是糖化血红蛋白(HbA1c)的变化,次要结局包括空腹血糖的变化、体重、低血糖发生率以及因不良事件导致的治疗中断情况。使用Cochrane协作网开发的RoB2工具对偏倚风险进行评估。使用RStudio 4.3.2版本、meta 7.0 - 0版本包和netmeta 2.9 - 0版本包进行统计分析。使用网络Meta分析置信度评估工具(CINeMA)评估网络Meta分析估计值的置信度。通过将每个结局的研究间共同方差(τ2)大小与异质性方差的经验分布进行比较来评估异质性。

结果

与胰岛素相比,每周一次注射1.5毫克度拉糖肽在降低糖化血红蛋白(HbA1c)方面表现更优,平均差值(MD)为 -0.35(95%置信区间:-0.51至 -0.19)。此外,1.5毫克度拉糖肽还表现出更大程度的体重减轻,MD为 -3.12(95%置信区间:-3.55至 -2.68)。然而,与胰岛素相比,其不良事件发生率也更高,优势比(OR)为1.40(95%置信区间:1.12至1.75)。与胰岛素相比,两种剂量的度拉糖肽(1.5毫克和0.75毫克)低血糖发生率均较低,OR分别为0.60(95%置信区间:0.41至0.87)和0.59(95%置信区间:0.41至0.86)。各治疗组在治疗中断方面无显著差异。

结论

在2型糖尿病管理中,度拉糖肽,尤其是较高剂量时,与icodec胰岛素相比,在降低糖化血红蛋白和降低低血糖风险方面显示出更优的疗效。然而,其使用也与较高的不良事件发生率相关。临床医生在为2型糖尿病患者选择最佳治疗策略时应仔细考虑这些因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/0e03a07386aa/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/03bb7c6b9465/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/fa80d03572cd/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/486864e08ee6/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/0e03a07386aa/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/03bb7c6b9465/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/fa80d03572cd/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/486864e08ee6/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f05/11064603/0e03a07386aa/gr4.jpg

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