Section of Endocrinology, Diabetes and Nutrition, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.
Am J Med. 2010 May;123(5):468.e9-17. doi: 10.1016/j.amjmed.2009.11.019.
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 metformin and/or sulfonylurea.
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 microg 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 microg twice daily or volume equivalent of placebo.
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.
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.
比较生活方式干预联合艾塞那肽与生活方式干预联合安慰剂对服用二甲双胍和/或磺酰脲类药物的超重或肥胖 2 型糖尿病患者体重减轻的影响。
本 24 周、多中心、随机、双盲、安慰剂对照研究纳入了 194 例患者，这些患者均接受生活方式干预，包括每天摄入 600 千卡热量和每周至少进行 2.5 小时的体力活动。患者随机分为 5μg 艾塞那肽每日 2 次皮下注射+生活方式干预组（n=96）或安慰剂+生活方式干预组（n=98），4 周后，艾塞那肽剂量增加至 10μg 每日 2 次或等体积安慰剂。
基线特征：（均数±标准差）年龄 54.8±9.5 岁；体重 95.5±16.0kg；糖化血红蛋白（HbA1c）7.6±0.8%。24 周时（最小二乘均数±标准误），两组治疗均显示热量摄入减少（艾塞那肽+生活方式干预组 -378±58 千卡/天 vs 安慰剂+生活方式干预组 -295±58 千卡/天，P=0.27）和运动衍生能量消耗增加。艾塞那肽+生活方式干预组体重减轻更明显（-6.16±0.54kg vs -3.97±0.52kg，P=0.003），糖化血红蛋白（HbA1c）下降更明显（-1.21±0.09% vs -0.73±0.09%，P<.0001），收缩压（-9.44±1.40mmHg vs -1.97±1.40mmHg，P<.001）和舒张压（-2.22±1.00mmHg vs 0.47±0.99mmHg，P=0.04）降低更明显。与安慰剂+生活方式干预组相比，艾塞那肽+生活方式干预组报告的恶心更多（分别为 44.8%和 19.4%，P<.001），但因不良反应（分别为 4.2%和 5.1%，P=1.0）或低血糖发生率导致的停药率无差异。
在服用二甲双胍和/或磺酰脲类药物的超重或肥胖 2 型糖尿病患者中，与生活方式干预相比，联合艾塞那肽治疗可显著减轻体重，改善血糖控制，并降低血压。
