Zhong Ping, Zeng Hai, Huang Miaochun, He Guoxin, Chen Zhixia
Department of Acupuncture and Moxibustion, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
College of Traditional Chinese Medicine, Jinan University, Guangzhou, China.
Front Pharmacol. 2021 Oct 6;12:695182. doi: 10.3389/fphar.2021.695182. eCollection 2021.
This meta-analysis aimed to combine the data available from clinical trials to assess the effects of subcutaneous and oral semaglutide administration on glycemic control, weight management, and safety outcomes in patients with type 2 diabetes (T2D). We systematically searched for phase 3 randomized controlled trials (RCTs) that compared semaglutide with placebo or other anti-diabetic drugs in T2D patients. The primary outcome was the change from baseline in glycated hemoglobin (HbA) levels. Secondary efficacy endpoints included the change from baseline in body weight, achievement of HbA targets, and clinically significant weight loss. Key safety outcomes were also assessed. In this meta-analysis, 24 trials with a total of 22185 patients were included. Subcutaneous semaglutide administration reduced HbA levels (weighted mean difference [WMD]: -1.14% and -1.37%, for 0.5 mg and 1 mg, respectively) and body weight (WMD: -2.73 kg and -4.09 kg, for 0.5 mg and 1 mg, respectively) when compared with placebo; its efficacy was also superior to other anti-diabetic drugs in reducing HbA levels (WMD: -0.71% and -0.86%, for 0.5 mg and 1 mg, respectively) and body weight (WMD: -2.65 kg and -3.78 kg, for 0.5 mg and 1 mg, respectively). Oral semaglutide administration was superior to placebo in decreasing HbA levels (WMD: -0.96% and -1.02%, for 7 mg and 14 mg, respectively). Moreover, oral administration of 14 mg of semaglutide also showed a significant reduction in HbA levels (WMD: -0.36%) compared with other anti-diabetic drugs. Furthermore, oral semaglutide administration resulted in substantial weight loss compared with other anti-diabetic drugs (WMD: -1.53 kg and -1.73 kg, for 7 mg and 14 mg, respectively). Notably, subcutaneous and oral semaglutide administration also resulted in higher numbers of patients achieving the targets of HbA levels and weight loss than placebo and other anti-diabetic drugs. Overall, we noted no clear evidence of detrimental effects on safety endpoints due to semaglutide treatment, except for some gastrointestinal adverse events. Both subcutaneous and oral semaglutide administration could enable the achievement of sufficient glycemic control and weight management without increasing the risk of hypoglycemia, which were effective and safe for the treatment of T2D.
这项荟萃分析旨在整合来自临床试验的可用数据，以评估皮下注射和口服司美格鲁肽对2型糖尿病（T2D）患者血糖控制、体重管理及安全性结果的影响。我们系统检索了在T2D患者中比较司美格鲁肽与安慰剂或其他抗糖尿病药物的3期随机对照试验（RCT）。主要结局是糖化血红蛋白（HbA）水平相对于基线的变化。次要疗效终点包括体重相对于基线的变化、HbA目标的达成情况以及具有临床意义的体重减轻。还评估了关键安全性结果。在这项荟萃分析中，纳入了24项试验，共22185例患者。与安慰剂相比，皮下注射司美格鲁肽可降低HbA水平（0.5mg和1mg时的加权平均差[WMD]分别为-1.14%和-1.37%）和体重（0.5mg和1mg时的WMD分别为-2.73kg和-4.09kg）；在降低HbA水平（0.5mg和1mg时的WMD分别为-0.71%和-0.86%）和体重（0.5mg和1mg时的WMD分别为-2.65kg和-3.78kg）方面，其疗效也优于其他抗糖尿病药物。口服司美格鲁肽在降低HbA水平方面优于安慰剂（7mg和14mg时的WMD分别为-0.96%和-1.02%）。此外，与其他抗糖尿病药物相比，口服14mg司美格鲁肽的HbA水平也显著降低（WMD：-0.36%）。此外，与其他抗糖尿病药物相比，口服司美格鲁肽导致体重显著减轻（7mg和14mg时的WMD分别为-1.53kg和-1.73kg）。值得注意的是，与安慰剂和其他抗糖尿病药物相比，皮下注射和口服司美格鲁肽还使更多患者达到了HbA水平和体重减轻的目标。总体而言，除了一些胃肠道不良事件外，我们未发现司美格鲁肽治疗对安全性终点有明显有害影响的明确证据。皮下注射和口服司美格鲁肽均可实现充分的血糖控制和体重管理，且不会增加低血糖风险，对T2D的治疗有效且安全。
