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皮下注射索马鲁肽辅助强化行为治疗可有效减轻超重或肥胖成人体重
作者:小柯机器人 发布时间:2021/2/28 15:54:46

美国宾夕法尼亚大学佩雷尔曼医学院Thomas A. Wadden团队比较了皮下注射索马鲁肽与安慰剂作为强化行为治疗的辅助手段对超重或肥胖成人体重的影响。2021年2月24日,《美国医学会杂志》发表了该研究。

减肥可以改善超重或肥胖人群的心脏代谢危险因素。强化生活方式干预和药物治疗是最有效的无创减肥方法。

为了比较每周一次对超重或肥胖成人皮下注射2.4mg索马鲁肽与安慰剂,作为强化行为疗法和初始低热量饮食辅助治疗的效果,2018年8月至2020年4月,研究组在美国的41个机构进行了一项随机、双盲、平行组、68周、临床3a期研究,招募了611名无糖尿病、超重(体重指数≥27)、至少1种共病或肥胖(体重指数≥30)的成年人。

将参与者按2:1的比例随机分组,其中407例皮下注射2.4 mg索马鲁肽,204例注射安慰剂,前8周均结合低热量饮食,68周期间进行强化行为治疗(即30次咨询访问)。共同主要终点为体重的百分比变化和到第68周体重下降5%及以上。验证性次要终点包括至少10%或15%的基线体重下降。

611名参与者中有495名女性(81.0%),平均年龄为46岁,平均体重105.8 kg,平均体重指数为38.0,共有567名(92.8%)完成试验,505名(82.7%)在试验结束时接受治疗。在第68周,与基线检查时相比,索马鲁肽组的平均体重下降了16.0%,安慰剂组下降了5.7%,组间差异显著。

索马鲁肽组体重减轻至少5%的参与者占86.6%,显著高于安慰剂组(47.6%)。索马鲁肽组体重减轻至少10%或15%的参与者分别占75.3%和27.0%,均显著高于安慰剂组(55.8%和13.2%)。索马鲁肽组中有82.8%的患者发生胃肠道不良事件,显著高于安慰剂组(63.2%),索马鲁肽组中有3.4%的参与者因此停止治疗,安慰剂组中没有参与者停药。

研究结果表明,对于超重或肥胖的成年人,每周皮下注射一次索马鲁肽作为强化行为治疗和初始低热量饮食的辅助手段,与安慰剂相比,在68周内体重明显减轻。

附:英文原文

Title: Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial

Author: Thomas A. Wadden, Timothy S. Bailey, Liana K. Billings, Melanie Davies, Juan P. Frias, Anna Koroleva, Ildiko Lingvay, Patrick M. O’Neil, Domenica M. Rubino, Dorthe Skovgaard, Signe O. R. Wallenstein, W. Timothy Garvey, STEP Investigators

Issue&Volume: 2021-02-24

Abstract:

Importance  Weight loss improves cardiometabolic risk factors in people with overweight or obesity. Intensive lifestyle intervention and pharmacotherapy are the most effective noninvasive weight loss approaches.

Objective  To compare the effects of once-weekly subcutaneous semaglutide, 2.4 mg vs placebo for weight management as an adjunct to intensive behavioral therapy with initial low-calorie diet in adults with overweight or obesity.

Design, Setting, and Participants  Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N=611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).

Interventions  Participants were randomized (2:1) to semaglutide, 2.4 mg (n=407) or placebo (n=204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.

Main Outcomes and Measures  The co–primary end points were percentage change in body weight and the loss of 5% or more of baseline weight by week 68. Confirmatory secondary end points included losses of at least 10% or 15% of baseline weight.

Results  Of 611 randomized participants (495 women [81.0%], mean age 46 years [SD, 13], body weight 105.8 kg [SD, 22.9], and body mass index 38.0 [SD, 6.7]), 567 (92.8%) completed the trial, and 505 (82.7%) were receiving treatment at trial end. At week 68, the estimated mean body weight change from baseline was –16.0% for semaglutide vs –5.7% for placebo (difference, 10.3 percentage points [95% CI, 12.0 to 8.6]; P<.001). More participants treated with semaglutide vs placebo lost at least 5% of baseline body weight (86.6% vs 47.6%, respectively; P<.001). A higher proportion of participants in the semaglutide vs placebo group achieved weight losses of at least 10% or 15% (75.3% vs 27.0% and 55.8% vs 13.2%, respectively; P<.001). Gastrointestinal adverse events were more frequent with semaglutide (82.8%) vs placebo (63.2%). Treatment was discontinued owing to these events in 3.4% of semaglutide participants vs 0% of placebo participants.

Conclusions and Relevance  Among adults with overweight or obesity, once-weekly subcutaneous semaglutide compared with placebo, used as an adjunct to intensive behavioral therapy and initial low-calorie diet, resulted in significantly greater weight loss during 68 weeks. Further research is needed to assess the durability of these findings.

DOI: 10.1001/jama.2021.1831

Source: https://jamanetwork.com/journals/jama/fullarticle/2777025

 

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex