Yang Liu, Duan Xueyu, Hua Peng, Wu Shilin, Liu Xiaobo
Department of Pharmacology, College of Pharmacy, Dali University, Dali, Yunnan Province, China.
Department of Pharmacy, The Third People's Hospital of Yunnan, Kunming, Yunnan Province, China.
J Res Med Sci. 2024 Sep 30;29:60. doi: 10.4103/jrms.jrms_693_23. eCollection 2024.
The objective of the study was to systematically evaluate the efficacy and safety of semaglutide in overweight or obese adults with or without type 2 diabetes.
The study, registered with PROSPERO (CRD42023450979), was designed as a systematic review and meta-analysis. Using a combination of subject matter and free words, a comprehensive search of Embase, PubMed, and Cochrane Library databases was performed to identify randomized controlled trials of semaglutide in overweight or obese adults with or without Type 2 diabetes mellitus from January 1, 2020, to July 14, 2023. The primary outcomes were the changes in body weight and adverse drug reaction (ADR). Random or fixed effects models were used in meta-analysis, pooling data as relative risks (RRs) or mean difference (MD) with 95% confidence intervals (CIs). Cochrane Collaboration's Risk of Bias tool was used to assess quality. Meta-analysis was performed using RevMan 5.3.
A total of 2490 publications were retrieved. Fifteen publications were finally included, totaling 6984 overweight or obese adult patients. Meta-analysis showed that compared with the control group, the semaglutide group was reduced more significantly in body weight (MD = -7.49, 95% CI [-9.92, -5.07], < 0.001), body mass index (MD = -3.35, 95% CI [-4.79, -1.92], < 0.001), waist circumference (MD = -7.26, 95% CI [-9.94, -4.58], < 0.001), as well as glycosylated hemoglobin (RR = -0.66, 95% CI [-1.07, -0.25], = 0.002), fasting blood glucose values (RR = -4.81, 95% CI [-7.03, -2.60], < 0.001), and systolic blood pressure (RR = -3.37, 95% CI [-5.32, -1.42], < 0.001), and the proportion of patients who lost > 5%, 10%, 15%, and 20% of their overall body weight, respectively (RR = 3.19, 95% CI [1.89, 5.36], < 0.001), (RR = 4.74, 95% CI [2.78, 8.11], < 0.001), (RR = 6.17, 95% CI [3.88, 9.82], < 0.001), and (RR = 9.14, 95% CI [6.05, 13.80], < 0.001) were also superior to the control group. Regarding safety, the incidence of total ADR in the semaglutide group was close to the placebo group. Still, gastrointestinal adverse effects such as nausea, vomiting, abdominal pain, and diarrhea were higher than those in the control group.
Semaglutide can effectively lose weight in overweight or obese adults with or without diabetes, potentially providing cardiovascular benefits; however, gastrointestinal adverse should be closely monitored.
本研究的目的是系统评价司美格鲁肽在患有或未患有2型糖尿病的超重或肥胖成年人中的疗效和安全性。
本研究已在国际前瞻性系统评价注册库（PROSPERO，注册号CRD42023450979）登记，设计为一项系统评价和荟萃分析。采用主题词和自由词相结合的方式，全面检索了Embase、PubMed和Cochrane图书馆数据库，以识别2020年1月1日至2023年7月14日期间司美格鲁肽在患有或未患有2型糖尿病的超重或肥胖成年人中的随机对照试验。主要结局为体重变化和药物不良反应（ADR）。荟萃分析采用随机效应模型或固定效应模型，将数据合并为相对风险（RRs）或平均差（MD），并给出95%置信区间（CIs）。采用Cochrane协作网的偏倚风险工具评估质量。使用RevMan 5.3进行荟萃分析。
共检索到2490篇文献。最终纳入15篇文献，共计6984例超重或肥胖成年患者。荟萃分析显示，与对照组相比，司美格鲁肽组的体重（MD = -7.49，95%CI [-9.92，-5.07]，P < 0.001）、体重指数（MD = -3.35，95%CI [-4.79，-1.92]，P < 0.001）、腰围（MD = -7.26，95%CI [-9.94，-4.58]，P < 0.001）、糖化血红蛋白（RR = -0.66，95%CI [-1.07，-0.25]，P = 0.002）、空腹血糖值（RR = -4.81，95%CI [-7.03，-2.60]，P < 0.001）和收缩压（RR = -3.37，95%CI [-5.32，-1.42]，P < 0.001）下降更为显著，且体重减轻超过总体重5%、10%、15%和20%的患者比例（RR = 3.19，95%CI [1.89，5.36]，P < 0.001）、（RR = 4.74，95%CI [2.78，8.11]，P < 0.001）、（RR = 6.17，95%CI [3.88，9.82]，P < 0.001）和（RR = 9.14，95%CI [6.05，13.80]，P < 0.001）也优于对照组。在安全性方面，司美格鲁肽组的总ADR发生率与安慰剂组相近，但恶心、呕吐、腹痛和腹泻等胃肠道不良反应高于对照组。
司美格鲁肽可有效降低患有或未患有糖尿病的超重或肥胖成年人的体重，可能具有心血管益处；然而，应密切监测胃肠道不良反应。
