Li Aihua, Su Xiaorong, Hu Shanshan, Wang Yong
Department of Pharmacy, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, Guangdong, China.
Department of Clinical Pharmacy, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
Diabetes Res Clin Pract. 2023 Apr;198:110605. doi: 10.1016/j.diabres.2023.110605. Epub 2023 Mar 5.
To investigate the efficacy and safety of oral semaglutide 7 and 14 mg, the only orally delivered glucagon-like peptide-1 (GLP-1) receptor agonist tablet approved for type 2 diabetes mellitus (T2DM) patients.
Search several databases for randomized controlled trials (RCTs) of oral semaglutide in patients with T2DM from inception through May 31, 2021. The primary outcomes included change from baseline in hemoglobin A1c (HbA1c) and body weight. Risk ratios (RR), mean differences (MD), and 95% confidence intervals (CI) were calculated to evaluate the outcomes.
This meta-analysis included 11 RCTs with a total of 9821 patients. Compared with placebo, semaglutide 7 and 14 mg reduced HbA1c by 1.06% (95% CI, 0.81-1.30) and 1.10% (95% CI, 0.88-1.31), respectively. While in comparison with other antidiabetic agents, semaglutide 7 and 14 mg reduced HbA1c by 0.26% (95% CI, 0.15-0.38) and 0.38% (95%CI, 0.31-0.45). Both doses of semaglutide could significantly reduce body weight. Semaglutide 14 mg did increase the incidence of medication discontinuation and gastrointestinal events (nausea, vomiting and diarrhea).
Once-daily semaglutide 7 and 14 mg can significantly lowered HbA1c and body weight in patients with T2DM, and this effect increases with dose. Significantly, more gastrointestinal events occurred with semaglutide 14 mg.
研究口服司美格鲁肽7毫克和14毫克的疗效及安全性，这是唯一获批用于2型糖尿病（T2DM）患者的口服胰高血糖素样肽-1（GLP-1）受体激动剂片剂。
检索多个数据库，查找从开始到2021年5月31日期间口服司美格鲁肽治疗T2DM患者的随机对照试验（RCT）。主要结局包括糖化血红蛋白（HbA1c）和体重相对于基线的变化。计算风险比（RR）、平均差（MD）和95%置信区间（CI）以评估结局。
该荟萃分析纳入了11项RCT，共9821例患者。与安慰剂相比，司美格鲁肽7毫克和14毫克分别使HbA1c降低了1.06%（95%CI，0.81-1.30）和1.10%（95%CI，0.88-1.31）。与其他抗糖尿病药物相比，司美格鲁肽7毫克和14毫克分别使HbA1c降低了0.26%（95%CI，0.15-0.38）和0.38%（95%CI，0.31-0.45）。两种剂量的司美格鲁肽均可显著降低体重。司美格鲁肽14毫克确实增加了停药和胃肠道事件（恶心、呕吐和腹泻）的发生率。
每日一次服用7毫克和14毫克司美格鲁肽可显著降低T2DM患者的HbA1c和体重，且这种效果随剂量增加而增强。值得注意的是，司美格鲁肽14毫克发生的胃肠道事件更多。
