Shi Fang-Hong, Li Hao, Cui Min, Zhang Zai-Li, Gu Zhi-Chun, Liu Xiao-Yan
Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Department of Pharmacy, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Front Pharmacol. 2018 Jun 4;9:576. doi: 10.3389/fphar.2018.00576. eCollection 2018.
Semaglutide, a newly once-weekly glucagon like peptide-1 (GLP-1) receptor agonist, has showed a favorable effect on glycaemic control and weight reduction in type 2 diabetes mellitus (T2DM). This meta-analysis was conducted to evaluate the clinical efficacy and safety of semaglutide in T2DM. A comprehensive searching was performed for Phase III randomized controlled trials (RCTs) which reported the efficacy and safety data of semaglutide and other therapies. The efficacy data expressed as weight mean difference (WMD) and the safety data expressed as risk ratios (RRs) were calculated by employing random-effects model. Heterogeneity was assessed through I test, and subgroup analyses were performed by different control groups, dosage of semaglutide, and durations of follow up. 9 RCTs including 9,773 subjects met the inclusion criteria. For efficacy, compared with other therapies, semaglutide resulted in a significant reduction in glycosylated hemoglobin (weight mean difference, WMD: -0.93%, 95% CI: -1.24 to -0.62, < 0.001), fasting plasma glucose (WMD: -1.15 mmol/L, 95% CI: -1.67 to -0.63, < 0.001), mean self-monitoring of plasma glucose (WMD: -1.19 mmol/L, 95% CI: -1.68 to -0.70, < 0.001), body weight (WMD: -3.47 kg, 95% CI: -3.96 to -2.98, < 0.001), body mass index (WMD: -1.25 kg/m, 95% CI: -1.45 to -1.04, < 0.001), systolic blood pressure (WMD: -2.55 mmHg, 95% CI: -3.22 to -1.88, < 0.001), with the exception of negative result of diastolic blood pressure (WMD: -0.29 mmHg, 95% CI: -0.65 to 0.07, = 0.113) and increased impact on pulse rate (WMD: -2.21, 95% CI: 1.54 to 2.88, < 0.001). The results were consistent across the key subgroups. For safety, semaglutide did not increase the risk of any adverse events, hypoglycemia and pancreatitis, but induced a higher risk of gastrointestinal disorders when compared with other therapies (RR: 1.98, 95%CI: 1.49 to 2.62, < 0.001). Semaglutide was effective and acceptable in patients with T2DM except for a high risk of gastrointestinal disorders. The capacity of glycaemic and body weight control of semaglutide appeared more effective than other add-on therapies including other GLP-1 receptor agonists of exenatide release and dulaglutide.
司美格鲁肽是一种新型的每周一次注射的胰高血糖素样肽-1（GLP-1）受体激动剂，已显示出对2型糖尿病（T2DM）患者的血糖控制和体重减轻有良好效果。本荟萃分析旨在评估司美格鲁肽在T2DM中的临床疗效和安全性。对报告了司美格鲁肽及其他疗法疗效和安全性数据的III期随机对照试验（RCT）进行了全面检索。采用随机效应模型计算以加权均数差（WMD）表示的疗效数据和以风险比（RRs）表示的安全性数据。通过I检验评估异质性，并按不同对照组、司美格鲁肽剂量和随访时间进行亚组分析。9项RCT（共9773名受试者）符合纳入标准。在疗效方面，与其他疗法相比，司美格鲁肽可显著降低糖化血红蛋白（加权均数差，WMD：-0.93%，95%CI：-1.24至-0.62，P<0.001）、空腹血糖（WMD：-1.15 mmol/L，95%CI：-1.67至-0.63，P<0.001）、平均自我监测血糖（WMD：-1.19 mmol/L，95%CI：-1.68至-0.70，P<0.001）、体重（WMD：-3.47 kg，95%CI：-3.96至-2.98，P<0.001）、体重指数（WMD：-1.25 kg/m²，95%CI：-1.45至-1.04，P<0.001）、收缩压（WMD：-2.55 mmHg，95%CI：-3.22至-1.88，P<0.001），但舒张压结果为阴性（WMD：-0.29 mmHg，95%CI：-0.65至0.07，P = 0.113）且对脉搏率的影响增加（WMD：-2.21，95%CI：1.54至2.88，P<0.001）。关键亚组的结果一致。在安全性方面，司美格鲁肽未增加任何不良事件、低血糖和胰腺炎的风险，但与其他疗法相比，胃肠道疾病风险更高（RR：1.98，95%CI：1.49至2.62，P<0.001）。除胃肠道疾病风险较高外，司美格鲁肽对T2DM患者有效且可接受。司美格鲁肽在控制血糖和体重方面似乎比其他附加疗法更有效，包括其他GLP-1受体激动剂艾塞那肽缓释剂和度拉糖肽。
