Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study
Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study
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DOI：
10.1016/s0140-6736(09)61375-1
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发表时间：
2009-11-07
期刊：
影响因子：
168.9
通讯作者：
Lean, Michael E. J.
中科院分区：
文献类型：
--
作者：
Astrup, Arne;Rossner, Stephan;Lean, Michael E. J.
背景近年来，肥胖的发生率急剧上升，但目前只有少数安全有效的药物可用。我们评估了利拉鲁肽对体重和耐受性的影响，肥胖的个人没有2型diabetes.Methods我们做了一个双盲，安慰剂对照20周的试验，开放标签奥利司他比较在欧洲的19个网站。564人（18-65岁，体重指数30-40 kg/m2）通过电话或网络系统随机分配至四种利拉鲁肽剂量之一Omg，n=90-95）或安慰剂（n=98），或口服奥利司他（120 mg，n= 95），每天三次。所有人每天摄入500千卡的能量不足饮食，并在整个试验期间增加体力活动，包括2周的磨合期。按意向治疗分析的体重变化是主要终点。随后进行了为期84周的开放标签扩展。该研究在ClinicalTrials.gov注册，编号NCT 00422058。结果利拉鲁肽组的受试者体重减轻显著多于安慰剂组（利拉鲁肽1.2 mg组p=0.003，安慰剂组p = 0.005）。
Background The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes.Methods We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18-65 years of age, body-mass index 30-40 kg/m(2)) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg, n=90-95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov, number NCT00422058.Findings Participants on liraglutide lost significantly more weight than did those on placebo (p=0.003 for liraglutide 1.2 mg and p