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每周一次胰高血糖素样肽-1 受体激动剂司美格鲁肽治疗 2 型糖尿病患者的安全性和有效性:系统评价和荟萃分析。

The safety and efficacy of once-weekly glucagon-like peptide-1 receptor agonist semaglutide in patients with type 2 diabetes mellitus: a systemic review and meta-analysis.

机构信息

Department of Pharmacy, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Qiaoxi District, 050051, Shijiazhuang, Hebei Province, China.

出版信息

Endocrine. 2018 Dec;62(3):535-545. doi: 10.1007/s12020-018-1708-z. Epub 2018 Aug 12.

Abstract

OBJECTIVES

To investigate the safety and efficacy of once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide as monotherapy or add-on to other antihyperglycaemic agents (AHAs) in patients with type 2 diabetes mellitus (T2DM).

METHODS

PubMed, Embase, Cochrane library and ClinicalTrials.gov were searched from the inception to January 18, 2018. Randomised controlled trials (RCTs) comparing semaglutide with placebo or other AHAs in T2DM patients were included in our meta-analysis. Risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CI) were used to evaluate the outcomes.

RESULTS

A total of 11 studies with 9519 patients were included in our meta-analysis. The results revealed that compared with placebo or other AHAs, semaglutide had further reduced the level of haemoglobin A1c (HbA1c) [MD 1.03%, 95% CI (0.85%, 1.22%), p < 0.00001], self-measured plasma glucose (SMPG) [MD 1.19 mmol/L, 95% CI (0.84 mmol/L, 1.53 mmol/L), p < 0.00001], fasting plasma glucose (FPG) [MD 1.33 mmol/L, 95% CI (0.97 mmol/L, 1.69 mmol/L), p < 0.00001] and weight [MD 3.61 kg, 95% CI (3.05 kg, 4.17 kg), p < 0.00001] and significantly increased participants who achieved HbA1c < 7.0% [RR 2.26, 95% CI (1.89, 2.70), p < 0.00001] in T2DM patients. Semaglutide had a significant increase in the incidence of adverse events (AEs) [RR 1.06, 95% CI (1.02, 1.11), p < 0.0001] and an analogous incidence in serious adverse events (SAEs) [RR 0.94, 95% CI (0.86, 1.02), p = 0.11] and hypoglycaemic events (severe or blood glucose (BG)-confirmed symptomatic) [RR 0.93, 95% CI (0.74, 1.16), p = 0.50] compared with the control group.

CONCLUSIONS

This article revealed that semaglutide had a favourable efficacy and safety in treating T2DM patients. It maybe a superior choice for T2DM patients who have obesity or a poor adherence to daily AHAs.

摘要

目的

研究每周一次胰高血糖素样肽-1(GLP-1)受体激动剂司美格鲁肽作为单药治疗或添加到其他抗高血糖药物(AHA)治疗 2 型糖尿病(T2DM)患者的安全性和疗效。

方法

从建库到 2018 年 1 月 18 日,检索了 PubMed、Embase、Cochrane 图书馆和 ClinicalTrials.gov。我们的荟萃分析纳入了比较司美格鲁肽与安慰剂或其他 T2DM 患者 AHA 的随机对照试验(RCT)。使用风险比(RR)和均数差(MD)及其 95%置信区间(CI)评估结局。

结果

我们的荟萃分析共纳入了 11 项研究的 9519 名患者。结果表明,与安慰剂或其他 AHA 相比,司美格鲁肽进一步降低了糖化血红蛋白(HbA1c)水平[MD 1.03%,95%CI(0.85%,1.22%),p<0.00001]、自我监测血浆葡萄糖(SMPG)[MD 1.19mmol/L,95%CI(0.84mmol/L,1.53mmol/L),p<0.00001]、空腹血糖(FPG)[MD 1.33mmol/L,95%CI(0.97mmol/L,1.69mmol/L),p<0.00001]和体重[MD 3.61kg,95%CI(3.05kg,4.17kg),p<0.00001],显著增加了 HbA1c<7.0%的患者比例[RR 2.26,95%CI(1.89,2.70),p<0.00001]。司美格鲁肽的不良反应(AE)发生率显著增加[RR 1.06,95%CI(1.02,1.11),p<0.0001],严重不良事件(SAE)发生率[RR 0.94,95%CI(0.86,1.02),p=0.11]和低血糖事件(严重或血糖(BG)证实的症状性)[RR 0.93,95%CI(0.74,1.16),p=0.50]与对照组相似。

结论

本文揭示了司美格鲁肽在治疗 T2DM 患者方面具有良好的疗效和安全性。对于肥胖或对每日 AHA 依从性差的 T2DM 患者,它可能是一种更好的选择。

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