Forst Thomas, Koch Cornelia, Dworak Markus
Profil Mainz GmbH & Co. KG , Mainz , Germany.
Curr Med Res Opin. 2015 Jun;31(6):1079-84. doi: 10.1185/03007995.2015.1039936. Epub 2015 May 20.
There is limited evidence to guide the selection of second-line anti-hyperglycemic agents in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with sulfonylurea monotherapy and are intolerant to metformin. We compared the efficacy and safety of vildagliptin 50 mg qd and Neutral Protamine Hagedorn (NPH) insulin qd in such patients.
This was a 24 week, multicenter, randomized, open-label study. The co-primary endpoints were (i) proportion of patients achieving HbA1c <7.0% without any confirmed hypoglycemic events (HEs) or weight gain ≥3% (composite endpoint); (ii) rate of confirmed HEs. Treatment satisfaction was assessed using the TSQM-9 questionnaire at study end.
A total of 162 patients were randomly assigned to vildagliptin (n = 83) and NPH insulin (n = 79). Similar proportion of patients achieved the composite endpoint in vildagliptin versus NPH insulin group (35.4% versus 34.2%; OR 0.985; 95% CI 0.507, 1.915; p = 0.96). After 24 weeks, 48.8% of patients in the vildagliptin group and 60.8% in the NPH insulin group achieved HbA1c <7.0%; 13.4% in the vildagliptin group and 29.1% in the insulin group had at least one confirmed HE; while 11.0% in the vildagliptin group and 22.8% in the insulin group experienced weight gain. The rate of confirmed HEs was significantly lower in patients receiving vildagliptin versus NPH insulin (1.3 versus 5.1 events per year). The TSQM-9 score for 'convenience' at week 24 increased significantly more with vildagliptin than with NPH insulin.
Addition of vildagliptin and NPH insulin resulted in a similar number of patients reaching HbA1c target without HEs or weight gain in T2DM patients inadequately controlled with sulfonylurea. The addition of vildagliptin to sulfonylurea could be considered as a treatment option prior to intensification with insulin, with the advantages of a lower HE rate and greater patient convenience. Study results are limited by a higher drop-out rate in the vildagliptin arm.
对于使用磺脲类单药治疗血糖控制不佳且不耐受二甲双胍的2型糖尿病（T2DM）患者，指导其选择二线降糖药物的证据有限。我们比较了维格列汀50mg每日一次与中性鱼精蛋白锌胰岛素（NPH胰岛素）每日一次在此类患者中的疗效和安全性。
这是一项为期24周的多中心、随机、开放标签研究。共同主要终点为：（i）在无任何确诊低血糖事件（HEs）或体重增加≥3%的情况下，糖化血红蛋白（HbA1c）<7.0%的患者比例（复合终点）；（ii）确诊HEs的发生率。在研究结束时使用TSQM-9问卷评估治疗满意度。
共有162例患者被随机分配至维格列汀组（n = 83）和NPH胰岛素组（n = 79）。维格列汀组与NPH胰岛素组达到复合终点的患者比例相似（35.4%对34.2%；比值比0.985；95%置信区间0.507, 1.915；p = 0.96）。24周后，维格列汀组48.8%的患者和NPH胰岛素组60.8%的患者HbA1c<7.0%；维格列汀组13.4%的患者和胰岛素组29.1%的患者至少有一次确诊HEs；维格列汀组11.0%的患者和胰岛素组22.8%的患者体重增加。接受维格列汀治疗的患者确诊HEs的发生率显著低于接受NPH胰岛素治疗的患者（每年1.3次事件对5.1次事件）。在第24周时，维格列汀组“便利性”的TSQM-9评分比NPH胰岛素组显著增加更多。
在磺脲类治疗控制不佳的T2DM患者中，加用维格列汀和NPH胰岛素使达到HbA1c目标且无HEs或体重增加的患者数量相似。在强化胰岛素治疗之前，可考虑将维格列汀加用至磺脲类药物，其优点是HEs发生率较低且患者便利性更高。研究结果因维格列汀组较高的脱落率而受到限制。
