Zhang Lin, Hua Zixin, Fang Zhenwei, Wei Juanjuan, Lin Yang
Department of Pharmacy, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Department of Clinical Pharmacy, Capital Medical University, Beijing, China.
J Clin Pharmacol. 2024 Oct;64(10):1312-1325. doi: 10.1002/jcph.2483. Epub 2024 Jun 14.
This study aims to systematically review the efficacy and safety of oral semaglutide in the treatment of type 2 diabetes mellitus (T2DM) and provide a basis for the rational use of the drug in clinical practice. From the database's inception until February 2023, a systematic search was conducted in PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Database, and China Science and Technology Journal Database to identify randomized controlled trials (RCTs) comparing the efficacy of oral semaglutide at dosages of 3, 7, and 14 mg (trial group) against placebo or other positive control drugs (control group) for the treatment of T2DM. Following literature screening and data extraction, the bias risk assessment tool in the Cochrane reviewer handbook 5.1.0 was used to evaluate the literature quality. Meta-analysis was carried out with RevMan 5.4 software. A total of 10 RCTs with 9541 patients were included. The meta-analysis results revealed that compared with placebo or positive control drugs (empagliflozin, sitagliptin, liraglutide, and dulaglutide), oral semaglutide significantly reduced the hemoglobin A1c (HbA1c) in patients (compared to placebo, 3 mg [MD = -0.61%, 95% CI (-0.89, -0.34)], 7 mg [MD = -1.12%, 95% CI (-1.45, -0.79)], 14 mg [MD = -1.08%, 95% CI (-1.32, -0.85)]; compared to positive control drugs (7 mg [MD = -0.26%, 95% CI (-0.38, -0.15)], 14 mg [MD = -0.37%, 95% CI (-0.52, -0.23)]). Oral semaglutide also showed certain advantages over placebo or positive control drugs in terms of weight loss, HbA1c reduction achievement rate, fasting plasma glucose level, and body mass index with overall dose-dependent efficacy. The incidence of nausea, diarrhea, and vomiting caused by oral semaglutide was higher than that of the placebo or positive control drugs, and the incidence of appetite decrease or constipation was higher than that of the placebo. Severe or symptomatic hypoglycemic episodes were reduced compared to positive control drugs. Oral semaglutide has definite clinical benefits of reducing blood glucose, body weight, reducing the risk of hypoglycemia, and with good safety.
本研究旨在系统评价口服司美格鲁肽治疗2型糖尿病（T2DM）的疗效和安全性，为其在临床实践中的合理用药提供依据。从数据库建立至2023年2月，在PubMed、Embase、Cochrane图书馆、Web of Science、中国知网、万方数据库和中国科技期刊数据库中进行系统检索，以识别比较3、7和14mg剂量口服司美格鲁肽（试验组）与安慰剂或其他阳性对照药物（对照组）治疗T2DM疗效的随机对照试验（RCT）。经过文献筛选和数据提取，使用Cochrane系统评价员手册5.1.0中的偏倚风险评估工具对文献质量进行评估。采用RevMan 5.4软件进行Meta分析。共纳入10项RCT，涉及9541例患者。Meta分析结果显示，与安慰剂或阳性对照药物（恩格列净、西格列汀、利拉鲁肽和度拉糖肽）相比，口服司美格鲁肽显著降低患者糖化血红蛋白（HbA1c）水平（与安慰剂相比，3mg[MD=-0.61%，95%CI（-0.89，-0.34）]，7mg[MD=-1.12%，95%CI（-1.45，-0.79）]，14mg[MD=-1.08%，95%CI（-1.32，-0.85）]；与阳性对照药物相比，7mg[MD=-0.26%，95%CI（-0.38，-0.15）]，14mg[MD=-0.37%，95%CI（-0.52，-0.23）]）。在体重减轻、HbA1c降低达标率、空腹血糖水平和体重指数方面，口服司美格鲁肽相对于安慰剂或阳性对照药物也显示出一定优势，且总体疗效呈剂量依赖性。口服司美格鲁肽引起的恶心、腹泻和呕吐发生率高于安慰剂或阳性对照药物，食欲减退或便秘发生率高于安慰剂。与阳性对照药物相比，严重或有症状的低血糖事件减少。口服司美格鲁肽在降低血糖、体重、降低低血糖风险方面具有确切的临床益处，且安全性良好。
