Comparison of effects of sitagliptin and voglibose on left ventricular diastolic dysfunction in patients with type 2 diabetes: results of the 3D trial.
Comparison of effects of sitagliptin and voglibose on left ventricular diastolic dysfunction in patients with type 2 diabetes: results of the 3D trial.
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DOI：
10.1186/s12933-015-0242-z
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发表时间：
2015-06-19
影响因子：
9.3
通讯作者：
FESC, for Effect of a DPP-4 inhibitor on left ventricular diastolic dysfunction in patients with type 2 diabetes and diabetic cardiomyopathy (3D) study investigators
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文献类型：
--
作者：
Oe H;Nakamura K;Kihara H;Shimada K;Fukuda S;Takagi T;Miyoshi T;Hirata K;Yoshikawa J;Ito H;FESC, for Effect of a DPP-4 inhibitor on left ventricular diastolic dysfunction in patients with type 2 diabetes and diabetic cardiomyopathy (3D) study investigators
2型糖尿病患者常可观察到左室舒张功能不全。二肽基肽酶-4抑制剂(DPP-4I)可减轻餐后高血糖(PPH)，并可能具有心脏保护作用。目前尚不清楚DPP-4i是否改善了2型糖尿病患者的左室舒张功能，如果是，这是由于PPH的减弱或DPP-4i的直接心脏效应。我们比较了DPP-4I、西格列汀和α-葡萄糖苷酶抑制剂伏格列波糖对2型糖尿病患者左室舒张功能的影响。我们进行了一项前瞻性、随机、开放标签的多中心研究，研究对象为100名伴有左室舒张功能不全的糖尿病患者。患者接受西格列汀(每日50毫克)或伏格列波糖(每日0.6毫克)治疗。主要终点是E‘血流速度和E/E’比值从基线到24周后的变化。次要疗效指标包括糖化血红蛋白、GLP-1、血脂、氧化应激标志物和炎症标志物。西格列汀组和伏格列波斯组分别有40名患者和40名患者完成了这项研究。两组E‘血流速度和E/E’比值从基线到24周后均无明显变化。然而，协方差分析表明，吡格列酮的使用是与e‘和E/e’比率变化相关的独立因素。在未使用吡格列酮的患者中，西格列汀和伏格列波糖组的E‘均增大，E/E’比值降低。仅西格列汀组GLP-1水平从基线上升至24周后(4.8 ± 4.7vs.7.3 ± 5.5pmol/L，p <； 0.0 5)。西格列汀组的糖化血红蛋白和体重下降幅度明显大于伏格列波糖组(−0.7 ± 0.6%vs.−0.3 ± 0.4p <； 0.005；−1.3vs.0.4 ± 3.2vs.0.4 ± 2.8g，p <； 0.05)。两组患者的血脂谱和炎症标志物均无变化。我们的试验表明，西格列汀降低HbA1c水平的作用比伏格列波糖更大，但两者都与改善糖尿病患者左室舒张功能的超声心动图参数无关。根据UMIN000003784在http://www.umin.ac.jp注册
Left ventricular (LV) diastolic dysfunction is frequently observed in patients with type 2 diabetes. Dipeptidyl peptidase-4 inhibitor (DPP-4i) attenuates postprandial hyperglycemia (PPH) and may have cardio-protective effects. It remains unclear whether DPP-4i improves LV diastolic function in patients with type 2 diabetes, and, if so, it is attributable to the attenuation of PPH or to a direct cardiac effect of DPP-4i. We compared the effects of the DPP-4i, sitagliptin, and the alpha-glucosidase inhibitor, voglibose, on LV diastolic function in patients with type 2 diabetes. We conducted a prospective, randomized, open-label, multicenter study of 100 diabetic patients with LV diastolic dysfunction. Patients received sitagliptin (50 mg/day) or voglibose (0.6 mg/day). The primary endpoints were changes in the e’ velocity and E/e’ ratio from baseline to 24 weeks later. The secondary efficacy measures included HbA1c, GLP-1, lipid profiles, oxidative stress markers and inflammatory markers. The study was completed with 40 patients in the sitagliptin group and 40 patients in the voglibose group. There were no significant changes in the e’ velocity and E/e’ ratio from baseline to 24 weeks later in both groups. However, analysis of covariance demonstrated that pioglitazone use is an independent factor associated with changes in the e’ and E/e’ ratio. Among patients not using pioglitazone, e’ increased and the E/e’ ratio decreased in both the sitagliptin and voglibose groups. GLP-1 level increased from baseline to 24 weeks later only in the sitagliptin group (4.8 ± 4.7 vs. 7.3 ± 5.5 pmol/L, p < 0.05). The reductions in HbA1c and body weight were significantly greater in the sitagliptin group than in the voglibose group (−0.7 ± 0.6 % vs. −0.3 ± 0.4, p < 0.005; −1.3 ± 3.2 kg vs. 0.4 ± 2.8 kg, p < 0.05, respectively). There were no changes in lipid profiles and inflammatory markers in both groups. Our trial showed that sitagliptin reduces HbA1c levels more greatly than voglibose does, but that neither was associated with improvement in the echocardiographic parameters of LV diastolic function in patients with diabetes. Registered at http://www.umin.ac.jp under UMIN000003784
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