Effectiveness of vildagliptin as add-on to metformin monotherapy among uncontrolled type 2 diabetes mellitus patients in a real-world setting
在一个真实世界环境中二甲双胍单药治疗后未控制的2型糖尿病患者加用维格列汀治疗的疗效
Abstract
enBackground
Vildagliptin is a dipeptidyl peptidase-4 inhibitor commonly used as a dual oral agent with metformin, thiazolidinediones, or sulfonylurea for the treatment of type 2 diabetes mellitus (T2DM). The efficacy of dual therapy with vildagliptin and metformin has been established in randomized controlled trials, but there is little evidence from observational studies. The aims of the present study were to evaluate the effectiveness of vildagliptin as an add-on therapy to metformin in reducing HbA1c and its affects on body weight and blood lipids in a real-life setting.
Methods
Included in the present retrospective cohort were T2DM patients (n = 345) who were uncontrolled on metformin monotherapy and intensified treatment with vildagliptin. The efficacy of at least 90 days of dual therapy with vildagliptin and metformin in reducing HbA1c levels, as well as changes in blood lipids and body weight, were evaluated.
Results
After 180 days (range 90–365 days) from the index date with a mean daily dose of 92 mg vildagliptin, HbA1c was significantly (P < 0.001) reduced by an average of 0.9% (95% confidence interval −1.0%, −0.7%). The absolute reduction in HbA1c was positively associated with baseline HbA1c levels. In addition to HbA1c, a modest but significant (P < 0.05) decrement was also calculated in the patients' body weight and blood lipids.
Conclusions
The present analysis of real-world data corroborates the results of previous randomized controlled trials indicating that add-on therapy with vildagliptin in uncontrolled patients on metformin monotherapy is associated with a significant improvement in the control of HbA1c.
摘要
zh背景
维格列汀是一种二肽基肽酶-4抑制剂, 在2型糖尿病的治疗中常与二甲双胍、噻唑烷二酮或者磺脲类药物组成双药联合口服治疗。既往在随机对照试验中已经证实了维格列汀联合二甲双胍双药治疗的有效性, 但是来自观察性研究的证据仍然很少。当前这项研究的目的是在一个真实的生活环境中评估二甲双胍联合维格列汀治疗后降低HbA1c的疗效以及对体重与血脂的影响。
方法
当前这项回顾性队列研究纳入的对象为二甲双胍单药治疗未能控制后加上维格列汀进行强化治疗的2型糖尿病患者(n=345)。使用维格列汀与二甲双胍双药治疗至少90天后再评估降低HbA1c水平的疗效, 以及血脂与体重的变化。
结果
从标志日期算起, 加用平均每日剂量为92 mg的维格列汀治疗180天(范围为90-365天)后, HbA1c平均显著(P < 0.001)下降了0.9%(95%置信区间为-1.0%,-0.7%)。HbA1c的绝对降幅与基线HbA1c水平呈正相关。除HbA1c外, 患者的体重以及血脂也有轻度但仍有显著性意义(P<0.05)的下降。
结论
当前这项真实世界的研究分析数据证实了既往随机对照试验的结果, 这表明二甲双胍单药治疗未能控制的患者加用维格列汀治疗后可以显著改善HbA1c的控制情况。
