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利拉鲁肽与格列美脲联合二甲双胍治疗对2型糖尿病亚临床心力衰竭的影响:一项随机开放平行组研究

Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin: A Randomized Open Parallel-Group Study.

作者信息

Nyström Thomas, Santos-Pardo Irene, Hedberg Fredric, Wardell Johan, Witt Nils, Cao Yang, Bojö Leif, Nilsson Bo, Jendle Johan

机构信息

Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.

Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.

出版信息

Front Endocrinol (Lausanne). 2017 Nov 14;8:325. doi: 10.3389/fendo.2017.00325. eCollection 2017.

Abstract

OBJECTIVE

We aimed to investigate the effect of liraglutide treatment on heart function in type 2 diabetes (T2D) patients with subclinical heart failure.

METHODS

Randomized open parallel-group trial. 62 T2D patients (45 male) with subclinical heart failure were randomized to either once daily liraglutide 1.8 mg, or glimepiride 4 mg, both add on to metformin 1 g twice a day. Mitral annular systolic (s') and early diastolic (e') velocities were measured at rest and during bicycle ergometer exercise, using tissue Doppler echocardiography. The primary endpoint was 18-week treatment changes in longitudinal functional reserve index (LFRI).

RESULTS

Clinical characteristics between groups (liraglutide = 33 vs. glimepiride = 29) were well matched. At baseline left ventricle ejection fraction (53.7 vs. 53.6%) and global longitudinal strain (-15.3 vs. -16.5%) did not differ between groups. There were no significant differences in mitral flow velocities between groups. For the primary endpoint, there was no treatment change [95% confidence interval] for: LFRI (-0.18 vs. -0.53 [-0.28, 2.59;  = 0.19]), or LFRI (-0.10 vs. -0.18 [-1.0, 1.7;  = 0.54]); for the secondary endpoints, there was a significant treatment change in respect of body weight (-3.7 vs. -0.2 kg [-5.5, -1.4;  = 0.001]), waist circumference (-3.1 vs. -0.8 cm [-4.2, -0.4;  = 0.019]), and heart rate (HR) (6.3 vs. -2.3 bpm [-3.0, 14.2;  = 0.003]), with no such treatment change in hemoglobin A1c levels (-11.0 vs. -9.2 mmol/mol [-7.0, 2.6;  = 0.37]), between groups.

CONCLUSION

18-week treatment of liraglutide compared with glimepiride did not improve LFRI, but however increased HR. There was a significant treatment change in body weight reduction in favor for liraglutide treatment.

摘要

目的

我们旨在研究利拉鲁肽治疗对患有亚临床心力衰竭的2型糖尿病(T2D)患者心脏功能的影响。

方法

随机开放平行组试验。62例患有亚临床心力衰竭的T2D患者(45例男性)被随机分为两组,一组每日一次皮下注射1.8 mg利拉鲁肽,另一组每日服用4 mg格列美脲,两组均联合每日两次服用1 g二甲双胍。使用组织多普勒超声心动图在静息状态和踏车运动期间测量二尖瓣环收缩期(s')和舒张早期(e')速度。主要终点是18周治疗期间纵向功能储备指数(LFRI)的变化。

结果

两组(利拉鲁肽组=33例 vs. 格列美脲组=29例)的临床特征匹配良好。基线时,两组间左心室射血分数(53.7% vs. 53.6%)和整体纵向应变(-15.3 vs. -16.5%)无差异。两组间二尖瓣血流速度无显著差异。对于主要终点,两组间LFRI无治疗差异[95%置信区间]:LFRI(-0.18 vs. -0.53 [-0.28, 2.59; P = 0.19]),或LFRI(-0.10 vs. -0.18 [-1.0, 1.7; P = 0.54]);对于次要终点,利拉鲁肽组在体重(-3.7 vs. -0.2 kg [-5.5, -1.4; P = 0.001])、腰围(-3.1 vs. -0.8 cm [-4.2, -

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc5d/5694660/38ecdebf91a1/fendo-08-00325-g001.jpg

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