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在常规护理中,用于治疗 2 型糖尿病的口服或注射用司美格鲁肽:一项比较匹配队列的多中心观察性研究。

Oral or injectable semaglutide for the management of type 2 diabetes in routine care: A multicentre observational study comparing matched cohorts.

机构信息

Department of Medicine, University of Padova, Padua, Italy.

Veneto Institute of Molecular Medicine (VIMM), Padua, Italy.

出版信息

Diabetes Obes Metab. 2024 Jun;26(6):2390-2400. doi: 10.1111/dom.15554. Epub 2024 Mar 13.

DOI:10.1111/dom.15554
PMID:38477183
Abstract

AIM

To investigate the real-world utilization and comparative clinical outcomes of injectable and oral semaglutide in individuals with type 2 diabetes (T2D) with the aim of enhancing understanding of the practical implications associated with choosing between these formulations.

METHODS

New users of oral or injectable semaglutide were selected from a cohort of 14 079 initiators of glucagon-like peptide-1 receptor agonists. Propensity-score matching (PSM) was employed to create balanced groups, ensuring comparability. The analysis encompassed dose exposure, drug persistence, and clinical outcomes, including changes in glycated haemoglobin (HbA1c) and body weight, with up to 18 months' follow-up.

RESULTS

We analysed two matched groups of 107 participants each, who comprised on average 63.6% men, aged 64 years, with diabetes duration of approximately 10 years, body mass index of 29 kg/m and HbA1c level of 7.7-7.8% (61-62 mmol/mol). The proportion of low, intermediate and high doses were similar with the oral and the injectable formulation. The change in HbA1c was similar between groups (-0.9% / -10 mmol/mol at 18 months) as was the proportion of individuals reaching HbA1c <6.5% (48 mmol/mol). The average change in body weight was similar in the two groups (-3.7 kg with injectable and -3.3 kg with oral at 18 months) but more new users of injectable semaglutide lost ≥5% body weight. Persistence on drug was longer with injectable than with oral semaglutide.

CONCLUSION

In a real-world setting, improvements in HbA1c and body weight were similar after initiation of oral or injectable semaglutide. These results may be specific to the features of the matched cohorts under investigation, with limited generalizability to populations with different characteristics.

摘要

目的

研究 2 型糖尿病(T2D)患者中注射用和口服司美格鲁肽的真实世界应用及临床结局对比,旨在深入了解这两种制剂选择的实际影响。

方法

从胰高血糖素样肽-1 受体激动剂(GLP-1RA)新使用者队列中选择口服或注射用司美格鲁肽的新使用者。采用倾向评分匹配(PSM)创建平衡组,确保可比性。分析包括剂量暴露、药物持续时间和临床结局,包括糖化血红蛋白(HbA1c)和体重的变化,随访时间长达 18 个月。

结果

我们分析了两组平均年龄 64 岁、男女比例为 63.6%、糖尿病病程约 10 年、体重指数 29kg/m²、HbA1c 水平为 7.7-7.8%(61-62mmol/mol)的 107 例患者匹配的每组各 107 例患者。口服和注射制剂的低、中、高剂量比例相似。两组的 HbA1c 变化相似(18 个月时为-0.9%/-10mmol/mol),达到 HbA1c<6.5%(48mmol/mol)的患者比例也相似。两组体重平均变化相似(注射用为-3.7kg,口服用为-3.3kg,18 个月),但更多新使用注射用司美格鲁肽的患者体重减轻≥5%。与口服司美格鲁肽相比,注射用司美格鲁肽的药物持续时间更长。

结论

在真实环境中,口服或注射用司美格鲁肽起始治疗后,HbA1c 和体重的改善相似。这些结果可能特定于所研究匹配队列的特征,对具有不同特征的人群的普遍性有限。

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