一种新型长效胰高血糖素样肽受体激动剂：度拉糖肽。
A novel, long-acting glucagon-like peptide receptor-agonist: dulaglutide.
作者信息
Gurung Tara, Shyangdan Deepson S, O'Hare Joseph Paul, Waugh Norman
机构信息
Warwick Evidence, University of Warwick, Coventry, UK.
Division of Metabolic and Vascular Health, Warwick Medical School, University of Warwick, Coventry, UK.
出版信息
Diabetes Metab Syndr Obes. 2015 Aug 10;8:363-86. doi: 10.2147/DMSO.S34418. eCollection 2015.
BACKGROUND
Dulaglutide is a new, long-acting glucagon-like peptide analogue in the treatment of type 2 diabetes. It is available in two doses, 0.75 and 1.5 mg, given by injection once weekly. This systematic review reports the effectiveness and safety of dulaglutide in type 2 diabetes in dual and triple therapy.
METHODS
MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, and conference abstracts were searched from 2005 to August 2014, and updated in January 2015. Company websites and references of included studies were checked for potentially relevant studies. European Medicines Agency and US Food and Drug Administration websites were searched.
RESULTS
Four trials were included. All were manufacturer-funded randomized controlled trials from the Assessment of Weekly Administration of Dulaglutide in Diabetes (AWARD) program. AWARD-1 compared dulaglutide 1.5 mg against exenatide 10 µg twice daily and placebo, AWARD-2 compared dulaglutide 0.75 and 1.5 mg against insulin glargine, AWARD-5 compared dulaglutide 0.75 and 1.5 mg against sitagliptin 100 mg and placebo, and AWARD-6 compared dulaglutide 1.5 mg against liraglutide 1.8 mg. The duration of follow-up in the trials ranged from 26 to 104 weeks. The primary outcome of all the included trials was change in HbA1c. At 26 weeks, greater HbA1c reductions were seen with dulaglutide than with twice daily exenatide (dulaglutide 1.5/0.75 mg: -1.5%/-1.3%; exe: 0.99%) and sitagliptin (1.5/0.75 mg -1.22%/-1.01%; sitagliptin: -0.6%). HbA1c change was greater with dulaglutide 1.5 mg (-1.08%) than with glargine (-0.63%), but not with dulaglutide 0.75 mg (-0.76%). Dulaglutide 1.5 mg was found to be noninferior to liraglutide 1.8 mg. More patients treated with dulaglutide achieved HbA1c targets of <7% and ≤6.5%. Reduction in weight was greater with dulaglutide than with sitagliptin and exenatide. Hypoglycemia was infrequent. The main adverse events were nausea, diarrhea, and vomiting.
CONCLUSION
Dulaglutide is effective in the treatment of patients with type 2 diabetes but we need long follow-up data for safety concerns.
背景
度拉糖肽是一种新型长效胰高血糖素样肽类似物，用于治疗2型糖尿病。它有两种剂量，即0.75毫克和1.5毫克，每周注射一次。本系统评价报告了度拉糖肽在2型糖尿病双重和三重治疗中的有效性和安全性。
方法
检索了2005年至2014年8月的MEDLINE、MEDLINE在研及其他未索引文献、EMBASE和会议摘要，并于2015年1月进行了更新。检查了公司网站和纳入研究的参考文献以寻找潜在的相关研究。检索了欧洲药品管理局和美国食品药品监督管理局的网站。
结果
纳入了四项试验。所有试验均为来自糖尿病度拉糖肽每周给药评估（AWARD）项目的由制造商资助的随机对照试验。AWARD-1将1.5毫克度拉糖肽与每日两次10微克艾塞那肽及安慰剂进行比较，AWARD-2将0.75毫克和1.5毫克度拉糖肽与甘精胰岛素进行比较，AWARD-5将0.75毫克和1.5毫克度拉糖肽与100毫克西格列汀及安慰剂进行比较，AWARD-6将1.5毫克度拉糖肽与1.8毫克利拉鲁肽进行比较。试验的随访时间为26至104周。所有纳入试验的主要结局是糖化血红蛋白（HbA1c）的变化。在26周时，度拉糖肽组的HbA1c降低幅度大于每日两次使用艾塞那肽组（度拉糖肽1.5毫克/0.75毫克：-1.5%/-1.3%；艾塞那肽：0.99%）和西格列汀组（1.5毫克/0.75毫克 -1.22%/-1.01%；西格列汀：-0.6%）。1.5毫克度拉糖肽组的HbA1c变化（-1.08%）大于甘精胰岛素组（-0.63%），但0.75毫克度拉糖肽组（-0.76%）并非如此。发现1.5毫克度拉糖肽不劣于1.8毫克利拉鲁肽。更多接受度拉糖肽治疗的患者达到了HbA1c<7%和≤6.5%的目标。度拉糖肽组的体重减轻幅度大于西格列汀组和艾塞那肽组。低血糖罕见。主要不良事件为恶心、腹泻和呕吐。
结论
度拉糖肽对2型糖尿病患者有效，但出于安全性考虑，我们需要长期随访数据。
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