A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
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DOI：
10.1056/nejmoa1411892
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发表时间：
2015-07-02
影响因子：
158.5
通讯作者：
Wilding, John P. H.
中科院分区：
文献类型：
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作者：
Pi-Sunyer, Xavier;Astrup, Arne;Wilding, John P. H.
背景：肥胖是一种具有严重健康后果的慢性疾病，但仅通过生活方式干预很难维持体重减轻。利拉鲁肽（Liraglutide）是一种胰高血糖素样肽-1类似物，已被证明对体重管理有潜在益处，每日一次剂量为3.0 mg，皮下注射。方法：我们进行了一项为期56周的双盲试验，涉及3731名非2型糖尿病患者，他们的身体质量指数（BMI；体重公斤除以身高米的平方）至少为30，如果他们接受过或未接受过血脂异常或高血压治疗，BMI至少为27。我们以2:1的比例随机分配患者接受每日一次皮下注射利拉鲁肽3.0 mg（2487例患者）或安慰剂（1244例患者）；两组都接受了生活方式改变的咨询。主要终点是体重的变化和患者体重减轻至少5%和超过10%的比例。结果基线时，患者平均（+/- SD）年龄为45.1 +/- 12.0岁，平均体重为106.2 +/- 21.4 kg，平均BMI为38.3 +/- 6.4；78.5%的患者为女性，61.2%为前驱糖尿病。在第56周，利拉鲁肽组患者的体重平均减轻8.4 +/- 7.3 kg，安慰剂组患者的体重平均减轻2.8 +/- 6.5 kg(差异为-5.6 kg； 95%可信区间为-6.0至-5.1；P
BACKGROUNDObesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously.METHODSWe conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2: 1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight.RESULTSAt baseline, the mean (+/- SD) age of the patients was 45.1 +/- 12.0 years, the mean weight was 106.2 +/- 21.4 kg, and the mean BMI was 38.3 +/- 6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4 +/- 7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8 +/- 6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P