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司美格鲁肽每周一次用于2型糖尿病患者:西班牙SURE多中心前瞻性观察研究结果

Once-Weekly Semaglutide Use in Patients with Type 2 Diabetes: Results from the SURE Spain Multicentre, Prospective, Observational Study.

作者信息

Bellido Virginia, Abreu Padín Cristina, Catarig Andrei-Mircea, Clark Alice, Barreto Pittol Sofía, Delgado Elias

机构信息

Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain.

Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, CSIC, Universidad de Sevilla, 41013 Sevilla, Spain.

出版信息

J Clin Med. 2022 Aug 23;11(17):4938. doi: 10.3390/jcm11174938.

Abstract

Type 2 diabetes (T2D) is a complex disease for which an individualised treatment approach is recommended. Once-weekly (OW) semaglutide is a glucagon-like peptide-1 receptor agonist approved for the treatment of insufficiently controlled T2D. The aim of this study was to investigate the use of OW semaglutide in adults with T2D in a real-world context. SURE Spain, from the 10-country SURE programme, was a prospective, multicentre, open-label, observational study, approximately 30 weeks in duration. Adults with T2D and ≥1 documented HbA value ≤12 weeks before semaglutide initiation were enrolled. Change in HbA from baseline to end of study (EOS) was the primary endpoint, with change in body weight (BW), waist circumference, and patient-reported outcomes as secondary endpoints. Of the 227 patients initiating semaglutide, 196 (86.3%) completed the study on-treatment with semaglutide. The estimated mean changes in HbA and body weight between baseline and EOS were -1.3%-points (95% confidence interval (CI) -1.51;-1.18%-points) and -5.7 kg (95% CI -6.36;-4.98 kg). No new safety concerns were identified. Therefore, in routine clinical practice in Spain, OW semaglutide was shown to be associated with statistically significant and clinically relevant reductions in HbA and BW in adults with T2D.

摘要

2型糖尿病(T2D)是一种复杂疾病,建议采用个体化治疗方法。每周一次(OW)司美格鲁肽是一种胰高血糖素样肽-1受体激动剂,已被批准用于治疗控制不佳的T2D。本研究的目的是在现实环境中调查OW司美格鲁肽在患有T2D的成人中的使用情况。来自10国SURE项目的西班牙SURE研究是一项前瞻性、多中心、开放标签的观察性研究,持续时间约30周。纳入了在开始使用司美格鲁肽前≤12周有≥1次记录的HbA值的T2D成人患者。从基线到研究结束(EOS)时HbA的变化是主要终点,体重(BW)、腰围变化以及患者报告的结局作为次要终点。在开始使用司美格鲁肽的227例患者中,196例(86.3%)完成了司美格鲁肽治疗期的研究。基线和EOS之间HbA和体重的估计平均变化分别为-−1.3个百分点(95%置信区间(CI)-−1.51;-−1.18个百分点)和-−5.7千克(95%CI-−6.36;-−4.98千克)。未发现新的安全问题。因此,在西班牙的常规临床实践中,OW司美格鲁肽被证明与患有T2D的成人患者HbA和BW的统计学显著且临床相关的降低有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a57f/9456474/51f0c16226de/jcm-11-04938-g001.jpg

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