维格列汀在心力衰竭合并2型糖尿病患者中的安全性研究

The Safety of Vildagliptin in Heart Failure Patients with Type 2 Diabetes Mellitus

为探索维格列汀在心力衰竭合并2型糖尿病患者中应用的安全性,连续入组心力衰竭合并2型糖尿病患者,随机分为维格列汀治疗组(n=64例)和对照组(n=63例)。对照组采用心衰优化治疗+二甲双胍单药降糖治疗,维格列汀治疗组在对照组用药的基础上加用维格列汀。观察指标包括左室射血分数(LVEF)、左室舒张末期容积(LVEDV)及收缩末期容积(LVESV)、6分钟步行试验及不良事件。12个月随访时,糖化血红蛋白整体降低均数为2.52%,较基线明显降低(P<0.001)。LVEF、LVEDV、LVESV及6分钟步行试验整体及两组均较基线无明显变化(P均>0.05)。组间不良事件比较无差异(P均>0.05)。因此,维格列汀未导致心力衰竭合并2型糖尿病患者左室功能的恶化及不良事件的发生。

To examine the safety of vildagliptin in patients with heart failure and type 2 diabetes mellitus.Patients with heart failure[left ventricular ejection fraction（LVEF）0.40]and type 2 diabetes were randomized to Vildagliptin group（n=64）or control group（n=63）.Control group was treated with optimized heart failure therapy and Metformin,while Vildagliptin group was treated with Vildagliptin based on the control group.The endpoints were LVEF,left ventricular end diastolic volume（LVEDV）and left ventricular end systolic volume（LVESV）,6 minutes walking test and adverse events.12 months follow-up,the overall glycosylated hemoglobin was reduced by 2.52%,significantly lower than baseline（P〈0.001）.There was no significant LVEF,LVEDV and LVESV change in all patients and in both groups（P〈0.05）.The increase of 6-minute walking test was 4.9 m（P=0.470）,and there was no statistically significant difference in the two groups（P〈0.05）.There was no difference in adverse events between groups（P〈0.05）.Therefore,Vildagliptin did not lead to worsening of left ventricular function and adverse events in patients concomitant heart failure and type 2 diabetes.