DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.
DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.
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DOI：
10.2337/dc09-1914
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发表时间：
2010-06
期刊：
影响因子：
16.2
通讯作者：
DURATION-1 Study Group
中科院分区：
文献类型：
--
作者：
Buse JB;Drucker DJ;Taylor KL;Kim T;Walsh B;Hu H;Wilhelm K;Trautmann M;Shen LZ;Porter LE;DURATION-1 Study Group
在糖尿病治疗中的应用：通过每周一次(持续时间-1)的艾塞那肽干预研究糖化血红蛋白、体重和其他因素的变化。在295名2型糖尿病患者中，比较了每周一次的胰升糖素样肽-1受体激动剂艾塞那肽(2毫克)和艾塞那肽BID治疗30周的安全性和有效性。现在，我们报告了1)继续治疗22周(总共52周)的患者和2)30周后从艾塞那肽BID改为艾塞那肽QW的患者的安全性和有效性。在这项随机、多中心、比较器对照、开放标签试验中，258名患者进入了为期22周的开放式评估阶段(n=128个QW；n=130个BID→QW)。评估A1C、空腹血糖(FPG)、体重、血压、空腹血脂、安全性和耐受性。继续服用艾塞那肽QW的患者在52周内A1C持续改善(最小二乘平均−为2.0%[95%CI−2.1%至−1.8%])。从艾塞那肽Bid改为艾塞那肽QW的患者获得了进一步的A1C改善；两组患者在52周时表现出相同的A1C下降和平均A1C(6.6%)。治疗52周时，A1C和≤的达标率分别为7.0%和6.5%。在两个治疗组中，52周后空腹血糖下降40 mg/dl，体重下降4公斤。在这一评估期间，恶心发生的频率较低，且主要是轻微的。没有观察到严重的低血糖。艾塞那肽QW在52周的治疗中在血糖控制和体重方面取得了持续的改善。改用艾塞那肽QW的患者A1C和空腹血糖进一步改善，体重持续下降。
In the Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide Once Weekly (DURATION-1) study, the safety and efficacy of 30 weeks of treatment with the glucagon-like peptide-1 receptor agonist exenatide once weekly (exenatide QW; 2 mg) was compared with exenatide BID in 295 patients with type 2 diabetes. We now report the safety and efficacy of exenatide QW in 1) patients who continued treatment for an additional 22 weeks (52 weeks total) and 2) patients who switched from exenatide BID to exenatide QW after 30 weeks. In this randomized, multicenter, comparator-controlled, open-label trial, 258 patients entered the 22-week open-ended assessment phase (n = 128 QW-only; n = 130 BID→QW). A1C, fasting plasma glucose (FPG), body weight, blood pressure, fasting lipids, safety, and tolerability were assessed. Patients continuing exenatide QW maintained A1C improvements through 52 weeks (least squares mean −2.0% [95% CI −2.1 to −1.8%]). Patients switching from exenatide BID to exenatide QW achieved further A1C improvements; both groups exhibited the same A1C reduction and mean A1C (6.6%) at week 52. At week 52, 71 and 54% of all patients achieved A1C <7.0% and ≤6.5%, respectively. In both treatment arms, FPG was reduced by >40 mg/dl, and body weight was reduced by >4 kg after 52 weeks. Nausea occurred less frequently in this assessment period and was predominantly mild. No major hypoglycemia was observed. Exenatide QW elicited sustained improvements in glycemic control and body weight through 52 weeks of treatment. Patients switching to exenatide QW experienced further improvements in A1C and FPG, with sustained weight loss.