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在使用两种口服药物治疗的 2 型糖尿病患者中,GLP-1RA、OAD 或胰岛素强化治疗的真实世界临床结局(PATHWAY 2-OADs)。

Real-world clinical outcomes following treatment intensification with GLP-1 RA, OADs or insulin in patients with type 2 diabetes on two oral agents (PATHWAY 2-OADs).

机构信息

Division of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA

Novo Nordisk A/S, Søborg, Denmark.

出版信息

BMJ Open Diabetes Res Care. 2020 Dec;8(2). doi: 10.1136/bmjdrc-2020-001830.

Abstract

INTRODUCTION

Most patients with type 2 diabetes require sequential addition of glucose-lowering agents to maintain long-term glycemic control. In this retrospective, observational study, we compared intensification with a glucagon-like peptide-1 receptor agonist (GLP-1 RA), oral antidiabetic drugs (OADs), and insulin in patients receiving two OADs, using US electronic health records and claims data.

RESEARCH DESIGN AND METHODS

For inclusion, patients in the IBM MarketScan Explorys database were required to have claims for two different OADs in the 180-day baseline period and ≥1 claim for a different OAD/GLP-1 RA/insulin at index date (treatment intensification). Changes in glycated hemoglobin (HbA) and weight from baseline were assessed at 180 days postindex. Patients were propensity score-matched by baseline characteristics and exact-matched by HbA category (HbA cohort and weight/composite outcomes cohort) and body mass index (BMI) category (weight/composite outcomes cohort only) to obtain balanced treatment arms. The primary endpoint was the percentage of patients reaching target HbA <7% (53 mmol/mol).

RESULTS

Significantly more patients intensifying with a GLP-1 RA achieved HbA <7% than those receiving OAD(s) (OR: 1.35; 95% CI 1.03 to 1.77; p=0.032) or insulin (OR: 1.77; 95% CI 1.27 to 2.47; p<0.001). GLP-1 RAs were also associated with a significantly greater chance of not gaining weight; significantly greater HbA and weight decreases from baseline; and a significantly greater chance of HbA <7%, no weight gain and discontinuation of ≥1 baseline OAD (composite outcome), compared with OAD(s) or insulin.

CONCLUSIONS

In propensity score-matched cohorts, GLP-1 RAs demonstrated significant benefits for both glycemic control and weight management over additional OAD(s) or insulin, respectively, indicating that they may represent the optimal choice at these points in the treatment pathway.

摘要

简介

大多数 2 型糖尿病患者需要连续添加降糖药物来维持长期血糖控制。在这项回顾性观察性研究中,我们使用美国电子健康记录和索赔数据,比较了在接受两种口服降糖药(OAD)的患者中,强化使用胰高血糖素样肽-1 受体激动剂(GLP-1RA)、OAD 和胰岛素的效果。

研究设计和方法

为了纳入研究,IBM MarketScan Explorys 数据库中的患者需要在 180 天的基线期内有两种不同的 OAD 用药记录,并且在索引日期(治疗强化)有至少一种不同的 OAD/GLP-1RA/胰岛素用药记录。在索引后 180 天评估糖化血红蛋白(HbA)和体重从基线的变化。根据基线特征进行倾向评分匹配,并根据 HbA 类别(HbA 队列和体重/综合结局队列)和体重指数(BMI)类别(仅体重/综合结局队列)进行精确匹配,以获得平衡的治疗组。主要终点是达到目标 HbA<7%(53 mmol/mol)的患者比例。

结果

与接受 OAD 治疗(OR:1.35;95%CI 1.03 至 1.77;p=0.032)或胰岛素治疗(OR:1.77;95%CI 1.27 至 2.47;p<0.001)的患者相比,接受 GLP-1RA 强化治疗的患者达到 HbA<7%的比例显著更高。与 OAD 或胰岛素相比,GLP-1RA 还与体重不增加的可能性显著增加、基线时 HbA 和体重显著下降以及 HbA<7%、体重无增加和至少一种基线 OAD 停药(综合结局)的可能性显著增加相关。

结论

在倾向评分匹配的队列中,GLP-1RA 在血糖控制和体重管理方面均优于 OAD 或胰岛素,这表明它们可能是治疗路径中这些点的最佳选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47f/7778743/3fcf9508146e/bmjdrc-2020-001830f01.jpg

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