Effects of Exenatide Combined with Lifestyle Modification in Patients with Type 2 Diabetes
Effects of Exenatide Combined with Lifestyle Modification in Patients with Type 2 Diabetes
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DOI：
10.1016/j.amjmed.2009.11.019
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发表时间：
2010-05-01
影响因子：
5.9
通讯作者：
Glass, Leonard C.
中科院分区：
文献类型：
--
作者：
Apovian, Caroline M.;Bergenstal, Richard M.;Glass, Leonard C.
目的：确定生活方式改变方案加依塞那肽与生活方式改变方案加安慰剂对用二甲双胍和/或磺脲类药物治疗的超重或肥胖2型糖尿病患者体重减轻的影响。在这项为期24周的多中心、随机、双盲、安慰剂对照研究中，194名患者参加了生活方式改变计划，包括600千卡/天的赤字和身体活动至少2.5小时/周的目标。参与者被随机分配到5 μ g艾塞那肽每日两次注射+生活方式改变计划（n = 96）或安慰剂+生活方式改变计划（n = 98），4周后，将艾塞那肽剂量增加到10 μ g每日两次或安慰剂的体积当量。（平均标准差）年龄：54.8 ± 9.5岁;体重：95.5 ± 16.0 kg;血红蛋白A（1c）：7.6 ± 0.8%。在第24周（最小二乘均值标准误），治疗组显示热量摄入相似的减少（-378 +/-58 vs 295 58 kcal/d，exenvelope+生活方式改变方案vs安慰剂+生活方式改变方案，P = 0.27），运动源性能量消耗增加。Exengland+生活方式改变计划显示体重变化更大（-6.16 +/- 0.54 kg vs -3.97 +/- 0.52 kg，P = .003），血红蛋白A（1c）（-1.21 +/- 0.09% vs -0.73 +/-0.09%，P < .0001），收缩压（-9.44 +/- 1.40 vs -1.97 +/- 1.40 mm Hg，P <0.001）和舒张压（-2.22 +/- 1.00 vs 0.47 +/- 0.99 mm Hg，P = 0.04）。艾塞那肽+生活方式改变方案组报告的恶心多于安慰剂+生活方式改变方案组（分别为44.8%和19.4%，P <0.001），由于不良事件导致的退出率没有差异（分别为4.2%和5.1%，P = 1.0）或低血糖发生率。当与生活方式改变相结合时，与单独生活方式改变相比，在接受二甲双胍和/或磺脲类药物治疗的超重或肥胖2型糖尿病参与者中，艾塞那肽治疗导致体重显著减轻，血糖控制改善，血压降低。(c)2010年爱思唯尔公司All rights reserved.美国医学杂志（2010）123，468.e9-468.e17
OBJECTIVE: To determine the effect of a lifestyle modification program plus exenatide versus lifestyle modification program plus placebo on weight loss in overweight or obese participants with type 2 diabetes treated with metfonnin and/or sulfonylurea.METHODS: In this 24-week, multicenter, randomized, double-blind, placebo-controlled study, 194 patients participated in a lifestyle modification program, consisting of goals of 600 kcal/day deficit and physical activity of at least 2.5 hours/week. Participants were randomized to 5 mu g exenatide twice daily injection + lifestyle modification program (n = 96) or placebo + lifestyle modification program (n = 98), and after 4 weeks increased their exenatide dose to 10 mu g twice daily or volume equivalent of placebo.RESULTS: Baseline characteristics: (mean standard deviation) age, 54.8 +/- 9.5 years; weight, 95.5 +/- 16.0 kg; hemoglobin A(1c), 7.6 +/- 0.8%. At 24 weeks (least squares mean standard error), treatments showed similar decreases in caloric intake (-378 +/- 58 vs 295 58 kcal/day, exenatide + lifestyle modification program vs placebo + lifestyle modification program, P = .27) and increases in exercise-derived energy expenditure. Exenatide + lifestyle modification program showed greater change in weight (-6.16 +/- 0.54 kg vs -3.97 +/- 0.52 kg, P = .003), hemoglobin A(1c) (-1.21 +/- 0.09% vs -0.73 +/- 0.09%, P < .0001), systolic (-9.44 +/- 1.40 vs -1.97 +/- 1.40 mm Hg, P < .001) and diastolic blood pressure (-2.22 +/- 1.00 vs 0.47 +/- 0.99 mm Hg, P = .04). Nausea was reported more for exenatide + lifestyle modification program than placebo + lifestyle modification program (44.8% vs 19.4%, respectively, P < .001), with no difference in withdrawal rates due to adverse events (4.2% vs 5.1%, respectively, P = 1.0) or rates of hypoglycemia.CONCLUSIONS: When combined with lifestyle modification, exenatide treatment led to significant weight loss, improved glycemic control, and decreased blood pressure compared with lifestyle modification alone in overweight or obese participants with type 2 diabetes on metformin and/or sulfonylurea treatment. (c) 2010 Elsevier Inc. All rights reserved. The American Journal of Medicine (2010) 123, 468.e9-468.e17