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每周一次司美格鲁肽与每日一次西格列汀作为二甲双胍附加疗法治疗 2 型糖尿病患者的疗效和安全性比较:系统评价和荟萃分析。

Comparative efficacy and safety profile of once-weekly Semaglutide versus once-daily Sitagliptin as an add-on to metformin in patients with type 2 diabetes: a systematic review and meta-analysis.

机构信息

Medicine, American University of Antigua, Antigua and Barbuda.

Medicine, Ghulam Muhammad Mahar Medical College, Sukkur, Pakistan.

出版信息

Ann Med. 2023;55(2):2239830. doi: 10.1080/07853890.2023.2239830.

Abstract

BACKGROUND

The emergence of genetically-modified human proteins and glucagon-like peptide-1 (GLP-1) receptor agonists have presented a promising strategy for effectively managing diabetes. Due to the scarcity of clinical trials focusing on the safety and efficacy of semaglutide as an adjunctive treatment for patients with type 2 diabetes who had inadequate glycemic control with metformin, we conducted a systematic review and meta-analysis. This was necessary to fill the gap and provide a comprehensive assessment of semaglutide compared to sitagliptin, a commonly prescribed DPP-4 inhibitor, in this patient population.

METHODS

A comprehensive and systematic search was carried out on reputable databases including PubMed, the Cochrane Library, and Elsevier's ScienceDirect to identify relevant studies that compared the efficacy of once-weekly Semaglutide with once-daily Sitagliptin in individuals diagnosed with type 2 diabetes mellitus. The analysis of the gathered data was performed utilizing the random-effects model, which considers both within-study and between-study variations.

RESULTS

The meta-analysis incorporated three randomized controlled trials (RCTs), encompassing 2401 participants, with a balanced distribution across the treatment groups. The primary focus of the study revolved around evaluating changes in HbA1C, blood pressure, pulse rate, body weight, waist circumference, and BMI. The findings revealed that once-weekly Semaglutide showed substantially improved HbA1C (WMD: -0.98; 95% CI: -1.28, -0.69, p-value: < 0.0001; I2: 100%), systolic (WMD: -3.73; 95% CI: -5.42, -2.04, p-value: <0.0001; I2: 100%) and diastolic blood pressures (WMD: -0.66; 95% CI: -1.02, -0.29, p-value: 0.0005; I2: 100%), and body weight (WMD: -3.17; 95% CI: -3.84, -2.49, p-value: <0.00001; I2: 100%) compared to once-daily Sitagliptin. However, there was an observed increase in pulse rate (WMD: 3.33; 95% CI: 1.61, 5.06, p-value: <0.00001; I2: 100%) associated with Semaglutide treatment. Regarding secondary outcomes, there was an elevated risk of total adverse events and premature treatment discontinuation with Semaglutide. The risk of serious, severe, moderate, and mild adverse events did not significantly differ between the two treatments.

CONCLUSIONS

In conclusion, the administration of once-weekly Semaglutide exhibited a substantial reduction in HbA1c, average systolic blood pressure (SBP), mean diastolic blood pressure (DBP), body weight, waist circumference, body mass index (BMI), and a rise in pulse rate, as opposed to the once-daily administration of Sitagliptin.

摘要

背景

基因改造的人类蛋白和胰高血糖素样肽-1 (GLP-1) 受体激动剂的出现为有效治疗糖尿病提供了一个有前景的策略。由于缺乏关注在二甲双胍治疗血糖控制不佳的 2 型糖尿病患者中,作为辅助治疗的司美格鲁肽的安全性和有效性的临床试验,我们进行了一项系统回顾和荟萃分析。这是必要的,以填补空白,并提供与西格列汀相比,在这一患者群体中,司美格鲁肽的全面评估。

方法

我们在包括 PubMed、Cochrane 图书馆和爱思唯尔的 ScienceDirect 在内的可靠数据库中进行了全面和系统的搜索,以确定比较每周一次司美格鲁肽与每日一次西格列汀在 2 型糖尿病患者中的疗效的相关研究。使用随机效应模型对收集的数据进行分析,该模型考虑了研究内和研究间的变化。

结果

荟萃分析纳入了三项随机对照试验 (RCT),共纳入 2401 名参与者,治疗组之间分布均衡。研究的主要重点是评估 HbA1C、血压、脉搏率、体重、腰围和 BMI 的变化。研究结果表明,每周一次的司美格鲁肽可显著降低 HbA1C(WMD:-0.98;95%CI:-1.28,-0.69,p 值:<0.0001;I2:100%)、收缩压(WMD:-3.73;95%CI:-5.42,-2.04,p 值:<0.0001;I2:100%)和舒张压(WMD:-0.66;95%CI:-1.02,-0.29,p 值:0.0005;I2:100%)和体重(WMD:-3.17;95%CI:-3.84,-2.49,p 值:<0.00001;I2:100%)与每日一次的西格列汀相比。然而,与司美格鲁肽治疗相关的脉搏率(WMD:3.33;95%CI:1.61,5.06,p 值:<0.00001;I2:100%)观察到增加。关于次要结局,司美格鲁肽治疗组总不良事件和提前停药的风险增加。两种治疗方法之间严重、严重、中度和轻度不良事件的风险没有显著差异。

结论

总之,每周一次的司美格鲁肽治疗可显著降低 HbA1c、平均收缩压(SBP)、平均舒张压(DBP)、体重、腰围、体重指数(BMI)和脉搏率,与每日一次的西格列汀治疗相比。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/644b/10375936/1a5aa32e8761/IANN_A_2239830_F0001_C.jpg

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