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2 型糖尿病中 GLP-1 受体激动剂与基础胰岛素的固定与灵活联合治疗:一项回顾性多中心比较效果研究。

Fixed versus flexible combination of GLP-1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study.

机构信息

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

Division of Metabolic Diseases, Padova Hospital, Padova, Italy.

出版信息

Diabetes Obes Metab. 2019 Nov;21(11):2542-2552. doi: 10.1111/dom.13840. Epub 2019 Aug 12.

Abstract

BACKGROUND AND AIMS

The combination of basal insulin (BI) and GLP-1 receptor agonists (GLP-1RAs) is a rational and effective therapy for patients with uncontrolled type 2 diabetes (T2D). We compared the effectiveness of fixed and flexible BI/GLP-1RA combinations using routinely accumulated clinical data.

METHODS

This was a retrospective, multicentre, real-world study concerning T2D patients initiating a fixed or flexible BI/GLP-1RA combination (NCT03959865). The primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight, fasting plasma glucose (FPG) and systolic blood pressure (SBP). Confounding was addressed by propensity score matching (PSM) or multivariable adjustment (MVA).

RESULTS

A total of 609 patients were included in the study, 131 in the fixed group and 478 in the flexible group. The two groups differed in terms of diabetes duration, body weight and concomitant medications. After 5.7 months, observed HbA1c reductions were 0.6% and 0.8%, and body weight reductions were 2.8 kg and 1.2 kg in the flexible and fixed groups, respectively. Following PSM, HbA1c declined similarly in the two groups, whereas reduction in body weight was significantly in favour of the flexible combination. Findings were robust in sensitivity analyses, with the exception that, with MVA, a significantly higher reduction in HbA1c was detected in the fixed group. Final doses of BI were higher in the fixed group, whereas those of GLP-1RA were higher in the flexible group.

CONCLUSIONS

In routine specialist care, initiation of the fixed or flexible BI/GLP-1RA combination allowed similar improvement in glycaemic control, but greater weight loss was observed with the flexible combination. This difference reflected dosages of BI and GLP-1RAs.

摘要

背景和目的

基础胰岛素(BI)和胰高血糖素样肽-1 受体激动剂(GLP-1RA)的联合治疗是控制不佳的 2 型糖尿病(T2D)患者的合理有效治疗方法。我们使用常规积累的临床数据比较了固定和灵活 BI/GLP-1RA 联合治疗的效果。

方法

这是一项回顾性、多中心、真实世界的 T2D 患者起始固定或灵活 BI/GLP-1RA 联合治疗的研究(NCT03959865)。主要终点是糖化血红蛋白(HbA1c)的变化。次要终点是体重、空腹血糖(FPG)和收缩压(SBP)的变化。混杂因素通过倾向评分匹配(PSM)或多变量调整(MVA)来解决。

结果

共纳入 609 例患者,固定组 131 例,灵活组 478 例。两组在糖尿病病程、体重和伴随用药方面存在差异。治疗 5.7 个月后,观察组 HbA1c 分别降低 0.6%和 0.8%,体重分别减轻 2.8kg 和 1.2kg。PSM 后,两组 HbA1c 下降相似,而体重减轻明显有利于灵活联合治疗。敏感性分析结果稳健,除外 MVA 时发现固定组 HbA1c 降低幅度显著更高。固定组 BI 的最终剂量较高,而灵活组 GLP-1RA 的剂量较高。

结论

在常规专科治疗中,起始固定或灵活 BI/GLP-1RA 联合治疗可使血糖控制得到相似改善,但灵活联合治疗时体重减轻更明显。这种差异反映了 BI 和 GLP-1RA 的剂量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e81f/6852173/afdc65effbe5/DOM-21-2542-g001.jpg

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