Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Diabetes Care. 2010 Jun;33(6):1255-61. doi: 10.2337/dc09-1914. Epub 2010 Mar 9.
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 <or=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.
在糖尿病治疗中的应用：通过每周一次给予艾塞那肽（DURATION-1）研究中干预措施，研究每周一次给予胰高血糖素样肽-1 受体激动剂艾塞那肽 2 毫克（艾塞那肽 QW）治疗 30 周的安全性和疗效，与每日两次给予艾塞那肽（艾塞那肽 BID）在 295 例 2 型糖尿病患者中的疗效进行比较。我们现将每周一次给予艾塞那肽 QW 在以下方面的安全性和疗效进行报告：1）患者继续接受治疗另外 22 周（共 52 周）；2）患者在 30 周后从每日两次给予艾塞那肽转换为每周一次给予艾塞那肽。
在这项随机、多中心、对照药物、开放性试验中，258 例患者进入 22 周开放性延长评估阶段（每周一次给予艾塞那肽组 128 例；每日两次给予艾塞那肽转换为每周一次给予艾塞那肽组 130 例）。评估糖化血红蛋白（A1C）、空腹血糖（FPG）、体重、血压、空腹血脂、安全性和耐受性。
继续接受每周一次给予艾塞那肽 QW 治疗的患者在 52 周时保持 A1C 的改善（最小二乘均值 -2.0%[95%CI-2.1 至-1.8%]）。从每日两次给予艾塞那肽转换为每周一次给予艾塞那肽的患者进一步实现 A1C 的改善；两组在第 52 周时均表现出相同的 A1C 降低和平均 A1C（6.6%）。在第 52 周时，所有患者中分别有 71%和 54%达到 A1C<7.0%和<或=6.5%。在两个治疗组中，FPG 降低超过 40mg/dl，体重减轻超过 4kg。在这个评估期间，恶心发生频率较低，主要为轻度。未观察到严重低血糖。
每周一次给予艾塞那肽 QW 在 52 周的治疗期间可使血糖控制和体重持续改善。转换为每周一次给予艾塞那肽 QW 的患者 A1C 和 FPG 进一步改善，体重持续减轻。
