Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospital, Oxford, UK.
Diabetes Obes Metab. 2018 Sep;20(9):2255-2263. doi: 10.1111/dom.13361. Epub 2018 Jun 10.
To assess the efficacy and safety of semaglutide, a recently approved glucagon-like peptide 1 receptor agonist (GLP-1 RA) for type 2 diabetes.
We searched major electronic databases and grey literature sources for randomized controlled trials comparing semaglutide with placebo or other antidiabetic agents. Primary outcome was change from baseline in HbA1c. Secondary endpoints included change from baseline in body weight, blood pressure, heart rate and incidence of hypoglycaemia, gastrointestinal adverse effects, pancreatitis and diabetic retinopathy.
A total of 6 placebo-controlled and 7 active-controlled studies with subcutaneous semaglutide were included. We identified only 1 trial with oral semaglutide. Compared with placebo, subcutaneous semaglutide 0.5 and 1 mg reduced HbA1c by 1.01% (95% CI, 0.56-1.47) and 1.38% (1.05-1.70), respectively. Both doses demonstrated superior glycaemic efficacy compared to other antidiabetic agents, including sitagliptin, exenatide, liraglutide, dulaglutide and insulin glargine. Semaglutide also had a beneficial effect on body weight (mean difference vs placebo -4.11 kg, 95% CI -4.85 to -3.37 for semaglutide 1 mg) and systolic blood pressure. We did not observe increased hypoglycaemia rates with semaglutide; nevertheless, we noted an increased incidence of nausea, vomiting and diarrhoea. Cases of pancreatitis were infrequent and the odds ratio for diabetic retinopathy compared with placebo was 1.32 (95% CI, 0.98-1.77).
Semaglutide is a potent once-weekly GLP-1 RA, significantly reducing HbA1c, body weight and systolic blood pressure. However, it is associated with increased incidence of gastrointestinal adverse events. Results for pancreatitis and retinopathy require further assessment in post-approval pharmacovigilance studies.
评估司美格鲁肽（一种新批准的胰高血糖素样肽 1 受体激动剂 [GLP-1RA]）治疗 2 型糖尿病的疗效和安全性。
我们检索了主要的电子数据库和灰色文献来源，以寻找比较司美格鲁肽与安慰剂或其他抗糖尿病药物的随机对照试验。主要结局是糖化血红蛋白（HbA1c）从基线的变化。次要终点包括体重、血压、心率和低血糖、胃肠道不良反应、胰腺炎和糖尿病视网膜病变的发生率从基线的变化。
共纳入 6 项安慰剂对照和 7 项活性对照的皮下司美格鲁肽研究。我们只发现了 1 项口服司美格鲁肽的试验。与安慰剂相比，皮下司美格鲁肽 0.5 和 1mg 分别降低 HbA1c 1.01%（95%CI，0.56-1.47）和 1.38%（1.05-1.70）。两种剂量与其他抗糖尿病药物相比均显示出更好的血糖疗效，包括西格列汀、艾塞那肽、利拉鲁肽、度拉糖肽和甘精胰岛素。司美格鲁肽对体重（与安慰剂相比的平均差异-4.11kg，95%CI-4.85 至-3.37 为司美格鲁肽 1mg）和收缩压也有有益的影响。我们没有观察到司美格鲁肽引起低血糖发生率增加；然而，我们注意到恶心、呕吐和腹泻的发生率增加。胰腺炎的病例很少，与安慰剂相比，糖尿病视网膜病变的比值比为 1.32（95%CI，0.98-1.77）。
司美格鲁肽是一种有效的每周一次 GLP-1RA，可显著降低 HbA1c、体重和收缩压。然而，它与胃肠道不良反应发生率增加有关。关于胰腺炎和视网膜病变的结果需要在批准后药物警戒研究中进一步评估。
