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恩格列净对比达格列净在二甲双胍、格列美脲和二肽基肽酶 4 抑制剂控制不佳的 2 型糖尿病患者中的应用:一项 52 周前瞻性观察研究。

Empagliflozin versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week prospective observational study.

机构信息

Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea; Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Republic of Korea.

Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea; Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Republic of Korea.

出版信息

Diabetes Res Clin Pract. 2019 May;151:65-73. doi: 10.1016/j.diabres.2019.04.008. Epub 2019 Apr 4.

Abstract

AIMS

To directly compare the effectiveness and safety between two distinct sodium-glucose co-transporter 2 (SGLT2) inhibitors, empagliflozin and dapagliflozin, as part of a quadruple oral antidiabetic agents (OADs) in patients with inadequately controlled type 2 diabetes (T2D).

METHODS

This study was an open-labeled, prospective, 52-week study conducted in T2D patients with glycated hemoglobin (HbA) ranging 7.5-12.0% with metformin, glimepiride and dipeptidyl peptidase-4 inhibitors. Patients were divided into either empagliflozin (25 mg/day) or dapagliflozin (10 mg/day). The outcome measures included changes in HbA, fasting plasma glucose (FPG), and cardiometabolic variables and the safety profiles.

RESULTS

In total, 350 patients were enrolled with empagliflozin (n = 176) and dapagliflozin (n = 174), respectively. After 52 weeks, both groups showed significant reductions in HbA and FPG, but the reduction was greater in the empagliflozin group (P < 0.001). Both groups showed significantly decreased blood pressure and body weight and high-density lipoprotein cholesterol levels were increased in the empagliflozin (between groups, P = 0.035). Both groups showed similar safety profiles.

CONCLUSIONS

Our study demonstrated that SGLT2 inhibitors can be effectively used as a fourth OAD in T2D patients who are treated with three other OADs. More specifically, empagliflozin was more effective in reducing HbA and improving other cardiometabolic parameters than dapagliflozin. Clinical Trial Number NCT03748810 (ClinicalTrials.gov).

摘要

目的

比较两种不同的钠-葡萄糖协同转运蛋白 2(SGLT2)抑制剂恩格列净和达格列净在治疗血糖控制不佳的 2 型糖尿病(T2D)患者的四重口服抗糖尿病药物(OADs)中的有效性和安全性。

方法

这是一项开放标签、前瞻性、52 周的研究,纳入了糖化血红蛋白(HbA)在 7.5-12.0%之间、正在接受二甲双胍、格列美脲和二肽基肽酶-4 抑制剂治疗的 T2D 患者。患者被分为恩格列净(25mg/天)或达格列净(10mg/天)组。主要观察指标包括 HbA、空腹血糖(FPG)和心血管代谢变量的变化以及安全性。

结果

共有 350 例患者分别入组恩格列净组(n=176)和达格列净组(n=174)。52 周后,两组患者的 HbA 和 FPG 均显著降低,但恩格列净组的降低更为显著(P<0.001)。两组患者的血压和体重均显著降低,高密度脂蛋白胆固醇水平升高,恩格列净组与达格列净组相比差异有统计学意义(P=0.035)。两组患者的安全性相似。

结论

我们的研究表明,SGLT2 抑制剂可作为治疗三种其他 OAD 的四重 OAD 在 T2D 患者中有效使用。更具体地说,恩格列净在降低 HbA 和改善其他心血管代谢参数方面比达格列净更有效。临床试验注册号 NCT03748810(ClinicalTrials.gov)。

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