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每周一次索马鲁肽治疗青少年肥胖安全有效
作者:小柯机器人 发布时间:2022/11/8 20:32:27

奥地利帕拉塞尔苏斯医科大学Daniel Weghuber团队研究了每周一次索马鲁肽治疗青少年肥胖的疗效与安全性。相关论文发表在2022年11月2日出版的《新英格兰医学杂志》上。

每周一次,2.4 mg皮下注射索马鲁肽(一种胰高血糖素样肽-1受体激动剂)可用于治疗成人肥胖,但对青少年人群的药物评估尚不清楚。

在这项双盲、平行组、随机、安慰剂对照试验中,研究组招募患有肥胖(体重指数[BMI]在第95百分位或更高)或超重(BMI在第85百分位及更高)且至少患一种与体重相关共病的青少年(12岁至18岁以下)。将参与者以2:1的比例随机分配,每周接受一次皮下注射索马鲁肽(剂量为2.4 mg)或安慰剂,持续68周,外加生活方式干预。主要终点是从基线到第68周BMI的百分比变化;次要验证终点是68周时体重减轻至少5%。

共有201名参与者接受了随机分组,180名(90%)完成了治疗。除一名参与者外,所有参与者都肥胖。索马鲁肽组从基线到第68周BMI平均降低16.1%,安慰剂组平均增加0.6%,估计差异为−16.7个百分点,组间差异显著。第68周时,索马鲁肽组131名参与者中有95名(73%)体重减轻5%或以上,而安慰剂组62名参与者中只有11名(18%),估计优势比为14.0,组间差异显著。

与安慰剂组相比,索马鲁肽组的体重下降和心脏代谢危险因素(腰围和糖化血红蛋白、高密度脂蛋白胆固醇除外的血脂、丙氨酸转氨酶水平)的改善更大。索马鲁肽组胃肠道不良事件的发生率高于安慰剂组(62%对42%)。索马鲁肽组有5名参与者(4%)患有胆石病,安慰剂组没有参与者患胆石病。索马鲁肽组133名参与者中有15名(11%)报告了严重不良事件,安慰剂组67名参与者中6名(9%)。

研究结果表明,在肥胖青少年中,每周接受一次2.4 mg剂量的索马鲁肽加上生活方式干预,比单独生活方式干预更能降低BMI。

附:英文原文

Title: Once-Weekly Semaglutide in Adolescents with Obesity | NEJM

Author: Daniel Weghuber, M.D.,, Timothy Barrett, Ph.D.,, Margarita Barrientos-Pérez, M.D.,, Inge Gies, Ph.D.,, Dan Hesse, Ph.D.,, Ole K. Jeppesen, M.Sc.,, Aaron S. Kelly, Ph.D.,, Lucy D. Mastrandrea, M.D.,, Rasmus Srrig, Ph.D.,, and Silva Arslanian, M.D.

Issue&Volume: 2022-11-02

Abstract:

Background

A once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is used to treat obesity in adults, but assessment of the drug in adolescents has been lacking.

Methods

In this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (12 to <18 years of age) with obesity (a body-mass index [BMI] in the 95th percentile or higher) or with overweight (a BMI in the 85th percentile or higher) and at least one weight-related coexisting condition. Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary end point was the percentage change in BMI from baseline to week 68; the secondary confirmatory end point was weight loss of at least 5% at week 68.

Results

A total of 201 participants underwent randomization, and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was 16.1% with semaglutide and 0.6% with placebo (estimated difference, 16.7 percentage points; 95% confidence interval [CI], 20.3 to 13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, lipids [except high-density lipoprotein cholesterol], and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.

Conclusions

Among adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone.

DOI: 10.1056/NEJMoa2208601

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2208601

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home