实际使用每周一次的西马鲁肽治疗2型糖尿病:来自德国的西马鲁肽实际证据(SURE)的结果。

IF 1.6 4区 医学 Q4 ENDOCRINOLOGY & METABOLISM Experimental and Clinical Endocrinology & Diabetes Pub Date : 2023-04-01 DOI:10.1055/a-2007-2061
Markus Menzen, Tina Landsvig Berentzen, Andrei-Mircea Catarig, Sebastian Piperhoff, Jörg Simon, Stephan Jacob
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引用次数: 6

摘要

背景:每周一次的西马鲁肽治疗2型糖尿病的有效性和安全性在3期SUSTAIN试验中得到了证实,该试验包括连续接受2型糖尿病治疗的患者。用真实世界的证据来补充这些发现是有用的。目的:SURE德国评估每周一次的西马鲁肽在现实世界2型糖尿病患者人群中的作用。设计/环境:这项前瞻性观察性研究是在93例成人临床实践中进行的,在开始使用西马鲁肽前≤12周,记录的糖化血红蛋白值为+≥1。干预:根据医生的判断,每周开一次西马鲁肽。主要结局:主要终点是糖化血红蛋白从基线到研究结束(~30周)的变化。次要终点包括体重变化和患者报告的结局。系统地收集和报告了所有不良事件,包括患者报告的记录和/或严重低血糖。结果:在完整分析集中的779例患者中,669例(85.9%)完成了西马鲁肽治疗的研究,构成了有效性分析集。在该数据集中,从基线到研究结束,糖化血红蛋白和体重的估计平均变化为-1.0% (-10.9 mmol/mol;ppp结论:在德国的现实世界人群中,每周接受一次西马鲁肽治疗的2型糖尿病患者在血糖控制和体重方面出现了临床显着改善。这些结果支持在德国成年2型糖尿病患者的常规临床实践中使用每周一次的西马鲁肽。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany.

Context: Efficacy and safety of once-weekly semaglutide in type 2 diabetes were established in the phase 3 SUSTAIN trials, which included patients across the continuum of type 2 diabetes care. It is useful to complement these findings with real-world evidence.

Objective: SURE Germany evaluated once-weekly semaglutide in a real-world type 2 diabetes patient population.

Design/setting: The prospective observational study was conducted at 93 clinical practices in adults with+≥ 1 documented glycated haemoglobin value ≤12 weeks before initiation of semaglutide.

Intervention: Once-weekly semaglutide was prescribed at the physicians' discretion.

Main outcomes: The primary endpoint was change in glycated haemoglobin from baseline to end-of-study (~30 weeks). Secondary endpoints included changes in body weight and patient-reported outcomes. All adverse events were systematically collected and reported, including patient-reported documented and/or severe hypoglycaemia.

Results: Of 779 patients in the full analysis set, 669 (85.9%) completed the study on treatment with semaglutide, comprising the effectiveness analysis set. In this data set, estimated mean changes in glycated haemoglobin and body weight from baseline to end-of-study were -1.0%point (-10.9 mmol/mol; P<0.0001) and -4.5 kg (-4.2%; P<0.0001). Sensitivity analyses supported the primary analysis. Improvements were observed in other secondary endpoints, including patient-reported outcomes. No new safety concerns were identified.

Conclusions: In a real-world population in Germany, patients with type 2 diabetes treated with once-weekly semaglutide experienced clinically significant improvements in glycaemic control and body weight. These results support the use of once-weekly semaglutide in routine clinical practice in adult patients with type 2 diabetes in Germany.

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来源期刊
CiteScore
4.10
自引率
5.60%
发文量
72
审稿时长
3 months
期刊介绍: Publishing outstanding articles from all fields of endocrinology and diabetology, from molecular biology to clinical research, this journal is a brilliant resource. Since being published in English in 1983, the popularity of this journal has grown steadily, reflecting the importance of this publication within its field. Original contributions and short communications appear in each issue along with reviews addressing current topics. In addition, supplementary issues are published each year presenting abstracts or proceedings of national and international scientific meetings. The journal was initially published in German and is still the oldest endocrinological periodical in the German-language market!
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