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基于肠促胰岛素疗法的疗效与安全性:临床试验数据

Efficacy and safety of incretin based therapies: clinical trial data.

作者信息

White John

机构信息

Department of Pharmacotherapy, College of Pharmacy, Washington State University, Spokane, WA 99210-1495, USA.

出版信息

J Am Pharm Assoc (2003). 2009 Sep-Oct;49 Suppl 1:S30-40. doi: 10.1331/JAPhA.2009.09079.

Abstract

OBJECTIVE

Provide a comprehensive overview of efficacy and safety data on incretin-based agents in the treatment of type 2 diabetes.

DATA SOURCES

A PubMed search was conducted for the years 2000-2009, using as keywords the names of glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide and liraglutide) and dipeptidyl peptidase-4 (DPP-4) inhibitors (sitagliptin, alogliptin, and saxagliptin). World Diabetes Congress abstracts from 2008 to 2009 were also searched for clinical studies of these agents.

STUDY SELECTION

The author included randomized controlled trials of incretin therapies that were published in English and enrolled > or =100 participants.

DATA EXTRACTION

Data on the effects of incretins on glycemic control, weight, beta-cell function, blood pressure, lipid levels, safety, and tolerability were extracted and summarized.

DATA SYNTHESIS

A total of 27 randomized controlled studies of incretin therapy were identified and included in the review. GLP-1 receptor agonists and DPP-4 inhibitors were evaluated at different points in the diabetes treatment spectrum, i.e., added to diet and exercise alone (monotherapy) or added to oral antihyperglycemic regimens (combination therapy).

CONCLUSION

In addition to decreasing glycemia in type 2 diabetes, incretin therapies may improve other important parameters, including beta-cell function, blood pressure, and lipid levels, with a low risk for hypoglycemia. A comparison of the study data differentiates the clinical profiles of the GLP-1 receptor agonists, which are associated with weight loss, and DPP-4 inhibitors, which are weight neutral, as well as the individual agents within each class.

摘要

目的

全面概述基于肠促胰岛素的药物治疗2型糖尿病的疗效和安全性数据。

数据来源

对2000 - 2009年期间进行PubMed检索,使用胰高血糖素样肽-1(GLP-1)受体激动剂(艾塞那肽和利拉鲁肽)及二肽基肽酶-4(DPP-4)抑制剂(西他列汀、阿格列汀和沙格列汀)的名称作为关键词。还检索了2008年至2009年世界糖尿病大会摘要中关于这些药物的临床研究。

研究选择

作者纳入了以英文发表且纳入≥100名参与者的肠促胰岛素疗法随机对照试验。

数据提取

提取并总结了肠促胰岛素对血糖控制、体重、β细胞功能、血压、血脂水平、安全性和耐受性影响的数据。

数据综合

共识别出27项肠促胰岛素疗法随机对照研究并纳入本综述。GLP-1受体激动剂和DPP-4抑制剂在糖尿病治疗谱的不同阶段进行评估,即单独加用饮食和运动(单药治疗)或加用口服降糖方案(联合治疗)。

结论

除降低2型糖尿病患者血糖外,肠促胰岛素疗法可能改善其他重要参数,包括β细胞功能、血压和血脂水平,低血糖风险低。研究数据比较区分了与体重减轻相关的GLP-1受体激动剂和体重中性的DPP-4抑制剂的临床特征,以及每类中的各个药物。

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