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达格列净联合利格列汀和二甲双胍治疗韩国 2 型糖尿病患者的真实世界临床疗效观察。

Effect of Dapagliflozin in Combination with Lobeglitazone and Metformin in Korean Patients with Type 2 Diabetes in Real-World Clinical Practice.

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.

Department of Biomedical Sciences, Inha University College of Medicine, Incheon, Korea.

出版信息

Yonsei Med J. 2022 Sep;63(9):825-833. doi: 10.3349/ymj.2022.63.9.825.

Abstract

PURPOSE

This study aimed to evaluate the efficacy and tolerability of dapagliflozin as an add-on or a switch therapy to lobeglitazone plus metformin (MFM) in Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.

MATERIALS AND METHODS

The study included 109 patients who started dapagliflozin as add-on or switch therapy to lobeglitazone plus MFM. The primary outcome was a change in glycated hemoglobin (HbA1c) level from baseline after 12 months of treatment. Secondary outcomes included changes in fasting plasma glucose (FPG), lipid profiles, body weight, visceral fat area (VFA), and blood pressure after 12 months of treatment.

RESULTS

The baseline HbA1c was 8.3±1.3% (8.7±1.5% in the add-on group and 8.1±1.0% in the switch group). After 12 months, mean HbA1c decreased (-0.91%) in all patients (<0.05) (-1.39% in the add-on group and -0.63% in the switch group). Significant reductions in FPG were also observed in both the add-on and switch groups (-54.37 mg/dL and -24.68 mg/dL, respectively). Overall, there was a significant improvement in serum triglyceride (-24.74 mg/dL), low density lipoprotein cholesterol (-7.92 mg/dL), body weight (-2.98 kg), VFA (-9.00 cm²), and systolic blood pressure (-8.67 mm Hg). Approximately 35.8% of patients achieved HbA1c <7.0% after 12 months.

CONCLUSION

Dapagliflozin, as an add-on or a switch therapy to lobeglitazone plus MFM, can be a suitable alternative for Korean patients with inadequately controlled T2DM. The combination therapy resulted in significant reductions in HbA1c levels, body weight, and blood pressure.

摘要

目的

本研究旨在评估达格列净作为附加或转换治疗在韩国 2 型糖尿病(T2DM)患者中的疗效和耐受性,这些患者正在接受罗格列酮联合二甲双胍(MFM)治疗,但血糖控制不佳。

材料和方法

该研究纳入了 109 例开始接受达格列净作为附加或转换治疗的患者,这些患者正在接受罗格列酮联合二甲双胍治疗。主要结局是治疗 12 个月后糖化血红蛋白(HbA1c)水平从基线的变化。次要结局包括治疗 12 个月后空腹血糖(FPG)、血脂谱、体重、内脏脂肪面积(VFA)和血压的变化。

结果

基线时的 HbA1c 为 8.3±1.3%(附加组为 8.7±1.5%,转换组为 8.1±1.0%)。治疗 12 个月后,所有患者的平均 HbA1c 均下降(-0.91%)(<0.05)(附加组下降 1.39%,转换组下降 0.63%)。附加组和转换组的 FPG 也均显著降低(分别为-54.37mg/dL 和-24.68mg/dL)。总体而言,血清甘油三酯(-24.74mg/dL)、低密度脂蛋白胆固醇(-7.92mg/dL)、体重(-2.98kg)、VFA(-9.00cm²)和收缩压(-8.67mmHg)均有显著改善。约 35.8%的患者在 12 个月后 HbA1c<7.0%。

结论

达格列净作为罗格列酮联合二甲双胍的附加或转换治疗,可作为韩国血糖控制不佳的 2 型糖尿病患者的一种合适选择。联合治疗可显著降低 HbA1c 水平、体重和血压。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9f0/9424781/daf3a24a4438/ymj-63-825-g001.jpg

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