Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus
Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus
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DOI：
10.1016/j.diabres.2008.10.006
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发表时间：
2009-02-01
影响因子：
5.1
通讯作者：
Tachibana, Hideo
中科院分区：
文献类型：
--
作者：
Kikuchi, Masatoshi;Abe, Nobuyuki;Tachibana, Hideo
目的：评价维达格列汀(10、25、50 mg，2次/d)治疗日本2型糖尿病(T2 DM)的疗效和耐受性。方法：对291例2型糖尿病患者进行为期12周的多中心、随机、双盲、安慰剂对照、平行对照研究。结果：基线糖化血红蛋白平均为7.4%，维达格列汀10、25和50 mg，2次/d的调整后糖化血红蛋白平均变化的治疗间差异(维达格列汀-安慰剂)分别为-0.8%、-1.0%和-1.2%(p<；0.001)。与基线相比，维格列汀组的体重没有显著变化。与安慰剂(73.6%)相比，维格列汀组的不良事件发生率(分别为62.0%、62.5%和61.8%、10、25和50毫克BID)没有增加。没有死亡或与药物有关的严重不良事件的报告。观察到7个降糖事件(维达格列汀10 mg和50 mg Bid和安慰剂分别发生4个事件(n=3)、2个事件(n=2)和1个事件(n=1))，没有一个是严重的或与剂量相关的。结论：Vldagliptin 50 mg Bid被认为是最有效和耐受性良好的剂量，因此可以被认为是日本T2 DM患者推荐的临床剂量。(C)2008爱思唯尔爱尔兰有限公司。保留所有权利。
Objective: To assess the efficacy and tolerability of vildagliptin (10, 25 or 50 mg bid) in Japanese patients with type 2 diabetes mellitus (T2DM).Methods: This 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study was performed in 291 patients. The primary assessment was change from baseline to endpoint in HbA1c.Results: Baseline HbA1c averaged 7.4%, and the between-treatment difference (vildagliptin-placebo) in the HbA1c adjusted mean change was -0.8%, -1.0% and -1.2% with vildagliptin 10, 25 and 50 mg bid, respectively (p < 0.001). Relative to baseline, body weight did not change significantly in vildagliptin groups. There was no increase in incidence of adverse events in the vildagliptin groups (62.0%, 62.5% and 61.8%, 10, 25 and 50 mg bid, respectively) compared to placebo (73.6%). No deaths or drug-related serious adverse events were reported. Seven hypoglycemic events were observed (four events (n = 3), two events (n = 2), and one event (n = 1) in the vildagliptin 10 and 50 mg bid, and placebo, respectively) and none of them were severe or dose related.Conclusion: Vildagliptin 50 mg bid was considered to be the most effective and well-tolerated dose, and therefore can be considered the recommended clinical dose for Japanese patients with T2DM. (C) 2008 Elsevier Ireland Ltd. All rights reserved.