Exenatide is Non-inferior to Insulin in Reducing HbA1c : An Integrated Analysis of 1423 Patients with Type 2 Diabetes
Exenatide is Non-inferior to Insulin in Reducing HbA1c : An Integrated Analysis of 1423 Patients with Type 2 Diabetes
复制标题
DOI：
10.3810/pgm.2010.05.2149
复制
发表时间：
2010-05-01
影响因子：
4.2
通讯作者：
Aronoff, Stephen
中科院分区：
文献类型：
--
作者：
Blevins, Thomas;Han, Jenny;Aronoff, Stephen
目的：目的是比较艾塞那肽和胰岛素之间的治疗效果，这是治疗2型糖尿病的2种基于肽的可注射疗法。研究方法：对1423例2型糖尿病患者的4项随机、开放标签、对照药物对照临床试验的数据进行汇总和分析，随访时间为16 - 52周。结果：在第26周，艾塞那肽的血糖控制（-1.2%HbA1c）不劣于胰岛素（-1.1%;艾塞那肽vs胰岛素; P = 0.09）。在HbA（1c）较基线降低的三分位数分析中，艾塞那肽与胰岛素相比诱导了相似的降低，在基线HbA（1c）最高的三分位数中观察到最大的降低（9%-12.7%）。艾塞那肽治疗诱导体重减轻（-2kg）和收缩压（SBP）从基线降低（SBP，-4.9mm Hg，艾塞那肽vs胰岛素; P < 0.0001）。相比之下，胰岛素治疗增加了体重（1.8 kg），SBP降低了-0.4 mm Hg。总体而言，艾塞那肽治疗的患者（70%）体重减轻是胰岛素治疗患者（21%）的3倍。艾塞那肽治疗组夜间轻度至中度低血糖的发生率（15%）低于胰岛素治疗组（29%;差异，-14; [ 95% CI，-18，-9.8]）。艾塞那肽对HbA（1c）和体重的影响持续到第52周。结论：这些结果表明艾塞那肽在血糖控制方面不劣于胰岛素。进一步的研究是必要的，以探讨exenglutamine对血压和体重的影响，以及对心血管结局的长期影响的潜力。
Objective: The objective was to compare the treatment effects between exenatide and insulin, which are 2 injectable peptide hormone-based therapy options for the treatment of type 2 diabetes mellitus. Methods: Data from 4 randomized, open-label, comparator-controlled clinical trials in 1423 patients with type 2 diabetes followed for 16 to 52 weeks were pooled and analyzed. Results: At 26 weeks, glycemic control with exenatide (-1.2% HbA(1c)) was non-inferior to insulin (-1.1%; exenatide vs insulin; P = 0.09). In a tertile analysis of HbA(1c) reduction from baseline, exenatide induced similar reductions compared with insulin, with the greatest reductions observed in the tertile with the highest baseline HbA(1c) (9%-12.7%). Exenatide treatment induced weight loss (-2 kg) and reduced systolic blood pressure (SBP) from baseline (SBP, -4.9 mm Hg, exenatide vs insulin; P < 0.0001). In contrast, insulin treatment increased body weight (1.8 kg) and decreased SBP by -0.4 mm Hg. Overall, about 3-fold more exenatide-treated patients (70%) experienced weight loss compared with those treated with insulin (21%). Occurrence of nocturnal mild-to-moderate hypoglycemia was lower with exenatide (15%) treatment than with insulin (29%; difference, -14; [ 95% CI, -18, -9.8]). Effects of exenatide on HbA(1c) and weight were sustained at 52 weeks. Conclusion: These findings indicate that exenatide is non-inferior to insulin for glycemic control. Further studies are warranted to explore the effects of exenatide on blood pressure and body weight, and the potential for long-term effects on cardiovascular outcomes.