Presbyterian College School of Pharmacy, Clinton, South Carolina, USA.
Department of Nursing Administration, Spartanburg Regional Healthcare System, Spartanburg, South Carolina, USA.
J Clin Pharm Ther. 2022 Feb;47(2):184-193. doi: 10.1111/jcpt.13574. Epub 2021 Dec 28.
The purpose of this review paper is to review the efficacy and safety of subcutaneous semaglutide, marketed as Wegovy, a glucagon-like peptide-1 receptor agonist for obesity management.
A MEDLINE search (1970 to June 2021) was conducted to identify Phase 3 trials of subcutaneous semaglutide for obesity management. Published Phase 3 trials from The Semaglutide Treatment Effect in People with obesity (STEP) program were reviewed and summarized.
Based on four Phase 3 trials, subcutaneous semaglutide as 2.4 mg once weekly was compared in efficacy and safety among 5000 randomized participants who were overweight or had obesity. A change in body weight from baseline to end of study was the primary outcome in the STEP program. Participants who received semaglutide had a dose-dependent reduction in body weight from baseline, compared to placebo. Higher percentages of participants had 5%-10% weight reduction from baseline when receiving subcutaneous semaglutide. The patient population was mainly middle-aged female participants with Class II obesity. Additional studies are needed, especially active-comparator trials, to determine the efficacy and safety of semaglutide in a diverse patient population.
Subcutaneous semaglutide is another available option as adjunct therapy to lifestyle modifications for people who are overweight or have obesity based on body weight and body mass index. It resulted in more weight reduction than placebo with gastrointestinal adverse events being the most common safety concerns. Clinical utilization of subcutaneous semaglutide will be determined, as insurance coverage will be a limitation for this new medication.
本文的目的是回顾皮下司美格鲁肽（商品名为 Wegovy）治疗肥胖症的疗效和安全性，这是一种胰高血糖素样肽-1 受体激动剂。
对 MEDLINE 数据库（1970 年至 2021 年 6 月）进行了检索，以鉴定用于肥胖症管理的皮下司美格鲁肽的 3 期临床试验。对司美格鲁肽治疗肥胖症人体疗效（STEP）项目的已发表的 3 期临床试验进行了回顾和总结。
基于四项 3 期临床试验，在超重或肥胖的 5000 名随机参与者中，比较了每周皮下注射 2.4mg 司美格鲁肽的疗效和安全性。STEP 项目的主要终点是从基线到研究结束时体重的变化。与安慰剂相比，接受司美格鲁肽治疗的患者体重呈剂量依赖性下降。与基线相比，接受皮下司美格鲁肽治疗的患者中有更高比例的患者体重减轻了 5%-10%。患者人群主要为中年女性，患有 II 级肥胖症。需要进一步的研究，特别是活性对照试验，以确定在不同患者人群中司美格鲁肽的疗效和安全性。
皮下司美格鲁肽是超重或肥胖患者除生活方式改变以外的另一种辅助治疗选择，其依据是体重和体重指数。与安慰剂相比，它能带来更多的体重减轻，但胃肠道不良事件是最常见的安全问题。皮下司美格鲁肽的临床应用将取决于保险覆盖范围，因为这将是这种新药物的一个限制因素。
