按种族和民族分列的 2.4 mg semaglutide 的疗效和安全性:三项随机对照试验的事后分析。

IF 4.2 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Obesity Pub Date : 2024-06-27 DOI:10.1002/oby.24042
Domenica Rubino, Hanna Angelene, Anthony Fabricatore, Jamy Ard
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引用次数: 0

摘要

研究目的本研究旨在评估胰高血糖素样肽-1受体激动剂塞马鲁肽 2.4 mg 在三项三期试验中的疗效和安全性:塞马鲁肽对肥胖症患者的治疗效果(STEP)临床试验评估了每周一次皮下注射塞马鲁肽 2.4 mg 的疗效和安全性。在此,对 STEP 1 和 STEP 3 的数据进行了汇总分析;对 STEP 2 的数据进行了单独研究。所有分析均使用了种族和民族亚组的数据。主要结果是估算出 semaglutide 2.4 mg 与安慰剂相比体重变化百分比的治疗差异:参与者报告的种族为白人(STEP 1 和 3,75.3%;STEP 2,59.4%)、黑人(8.8%;8.9%)、亚裔(10.6%;27.3%)或其他种族群体(5.3%;4.4%);种族为西班牙裔或拉丁裔(13.9%;11.9%)或非西班牙裔或拉丁裔(83.9%;88.1%)。治疗效果与种族(STEP 1 和 3:p ≥ 0.07;STEP 2:p ≥ 0.15)或种族(p ≥ 0.40;p ≥ 0.85)之间没有明显的交互作用。在不同亚组中,塞马鲁肽 2.4 毫克的安全性是一致的:结论:在STEP 1和3以及STEP 2中,与安慰剂相比,塞马鲁肽的治疗效果具有显著的统计学意义,并且在所有种族和民族亚组中都具有临床相关性。两个样本中的所有亚组都表现出良好的耐受性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Efficacy and safety of semaglutide 2.4 mg by race and ethnicity: A post hoc analysis of three randomized controlled trials

Efficacy and safety of semaglutide 2.4 mg by race and ethnicity: A post hoc analysis of three randomized controlled trials

Objective

The objective of this study was to evaluate the efficacy and safety of semaglutide 2.4 mg, a glucagon-like peptide-1 receptor agonist, by race and ethnicity, across three phase 3 trials.

Methods

The Semaglutide Treatment Effect in People with Obesity (STEP) clinical trials evaluated the efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg. Here, STEP 1 and 3 data were pooled for analysis; STEP 2 data were examined separately. All analyses were conducted using data from racial and ethnic subgroups. The primary outcome was the estimated treatment difference in percent body weight change for semaglutide 2.4 mg versus placebo.

Results

Participants reported race as White (STEP 1 and 3, 75.3%; STEP 2, 59.4%), Black (8.8%; 8.9%), Asian (10.6%; 27.3%), or other racial group (5.3%; 4.4%); and ethnicity as Hispanic or Latino (13.9%; 11.9%) or not Hispanic or Latino (83.9%; 88.1%). There were no significant interactions between treatment effect and race (STEP 1 and 3: p ≥ 0.07; STEP 2: p ≥ 0.15) or ethnicity (p ≥ 0.40; p ≥ 0.85). The safety of semaglutide 2.4 mg was consistent across subgroups.

Conclusions

The treatment effect of semaglutide was statistically significant versus placebo and clinically relevant across all racial and ethnic subgroups in STEP 1 and 3 and STEP 2. All subgroups across both samples demonstrated good tolerability.

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来源期刊
Obesity
Obesity 医学-内分泌学与代谢
CiteScore
11.70
自引率
1.40%
发文量
261
审稿时长
2-4 weeks
期刊介绍: Obesity is the official journal of The Obesity Society and is the premier source of information for increasing knowledge, fostering translational research from basic to population science, and promoting better treatment for people with obesity. Obesity publishes important peer-reviewed research and cutting-edge reviews, commentaries, and public health and medical developments.
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