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每周一次司美格鲁肽治疗 2 型糖尿病患者:加拿大 LMC 糖尿病登记处(SPARE 研究)的真实世界分析。

Semaglutide once weekly in people with type 2 diabetes: Real-world analysis of the Canadian LMC diabetes registry (SPARE study).

机构信息

LMC Diabetes and Endocrinology, Toronto, Ontario, Canada.

Novo Nordisk Canada Inc, Mississauga, Ontario, Canada.

出版信息

Diabetes Obes Metab. 2020 Nov;22(11):2013-2020. doi: 10.1111/dom.14117. Epub 2020 Jul 13.

Abstract

AIMS

To investigate real-world short-term clinical outcomes in adults with type 2 diabetes (T2D) who initiated semaglutide in a specialist endocrinology practice in Canada.

MATERIALS AND METHODS

This study was a retrospective observational study using data from the Canadian LMC Diabetes Registry. Adults with T2D who were naïve to glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy, initiated semaglutide therapy as usual standard of care between February 2018 and February 2019, and maintained semaglutide therapy during follow-up, were eligible for analysis. The primary outcome was mean change in glycated haemoglobin (HbA1c) at 3- to 6-month follow-up.

RESULTS

In the final analytical cohort (n = 937), there was a statistically significant mean ± SD reduction in HbA1c of -1.03 ± 1.24% (11.3 ± 13.6 mmol/mol, P < 0.001) and weight of -3.9 ± 4.0 kg (P < 0.001), with no significant change in self-reported incidence of hypoglycaemia. There was a significant reduction in HbA1c and weight regardless of number of co-therapies or semaglutide dose. However, adults using the 1.0-mg dose had a significantly greater reduction in HbA1c compared to adults using the 0.25- to 0.5-mg dose (between-group difference - 0.24 ± 0.06%, 2.6 ± 0.7 mmol/mol; P < 0.001). Adults using basal-bolus therapy required a significantly lower median total daily dose of insulin after adding semaglutide (0.82 vs. 0.93 U/kg; P < 0.001).

CONCLUSIONS

This retrospective observational study demonstrated that GLP-1RA-naïve adults with T2D initiating semaglutide in a real-world clinical practice had a statistically and clinically significant reduction in HbA1c and body weight after 3 to 6 months, regardless of semaglutide dose or order of semaglutide therapy, with no significant change in reported incidence of hypoglycaemia.

摘要

目的

研究在加拿大一家内分泌专科诊所接受司美格鲁肽治疗的 2 型糖尿病(T2D)成人的真实世界短期临床结局。

材料和方法

这是一项回顾性观察性研究,使用了加拿大 LMC 糖尿病登记处的数据。于 2018 年 2 月至 2019 年 2 月期间,新接受胰高血糖素样肽-1 受体激动剂(GLP-1RA)治疗的 T2D 成人,按常规标准护理接受司美格鲁肽治疗,且在随访期间继续接受司美格鲁肽治疗,有资格进行分析。主要结局为 3-6 个月随访时糖化血红蛋白(HbA1c)的平均变化。

结果

在最终分析队列(n=937)中,HbA1c 平均下降了-1.03±1.24%(11.3±13.6mmol/mol,P<0.001),体重平均下降了-3.9±4.0kg(P<0.001),且报告的低血糖发生率无显著变化。无论共用药数量或司美格鲁肽剂量如何,HbA1c 和体重均显著下降。然而,使用 1.0mg 剂量的成年人与使用 0.25-0.5mg 剂量的成年人相比,HbA1c 下降幅度显著更大(组间差异-0.24±0.06%,2.6±0.7mmol/mol;P<0.001)。开始添加司美格鲁肽后,接受基础-餐时胰岛素治疗的成年人需要的胰岛素总日剂量中位数显著降低(0.82vs.0.93U/kg;P<0.001)。

结论

这项回顾性观察性研究表明,在真实世界临床实践中,新接受司美格鲁肽治疗的 GLP-1RA 初治 T2D 成年人,在 3-6 个月后,HbA1c 和体重有统计学和临床意义的下降,无论司美格鲁肽剂量或司美格鲁肽治疗顺序如何,且报告的低血糖发生率无显著变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69fc/7689820/f6a77642e561/DOM-22-2013-g001.jpg

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