Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetes
Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetes
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DOI：
10.1016/j.diabres.2006.12.009
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发表时间：
2007-04-01
影响因子：
5.1
通讯作者：
Dejager, Sylvie
中科院分区：
文献类型：
--
作者：
Pi-Sunyer, F. Xavier;Schweizer, Anja;Dejager, Sylvie
这项为期24周的双盲、随机、多中心、安慰剂对照、平行组研究在354例未接受药物治疗的2型糖尿病（T2DM）患者中进行，评估了维格列汀（50mg qd、50mg bid或100mg qd）的疗效和耐受性。主要评估是血红蛋白A1c从基线到终点的变化，通过ANCOVA比较维格列汀和安慰剂。基线A1C平均为8.4%，在接受维格列汀50 mg qd、50 mg bid或100 mg qd的患者中，A1C调整平均变化（AM Delta）的治疗间差异（维格列汀-安慰剂）分别为-0.5 0.2% （P = 0.011）、-0.7 +/- 0.2% （P < 0.001）和-0.9 +/- 0.2% （P < 0.001）。基线FPG平均10.5 mmol/L；每日服用维格列汀50 mg组AM - Delta FPG治疗间差异为-0.6 +/- 0.4 mmol/L，每日服用100 mg组AM - Delta FPG治疗间差异为-1.3 +/- 0.4 mmol/L （P = 0.001）。相对于基线，三个维格列汀组的体重没有显著变化，安慰剂组的体重下降了1.4 +/- 0.4 kg。两组不良事件（AE）发生频率相似：分别接受维格列汀50mg qd、50mg bid、100mg qd或安慰剂的患者发生AE的比例分别为55.8%、59.3%、59.3%和57.6%。无确诊低血糖报告。结论：维格列汀对未用药的T2DM患者有效且耐受性良好，100mg维格列汀无论是单次给药还是分次给药，均具有相似的临床获益。2007爱思唯尔爱尔兰有限公司版权所有。
This 24-week, double-blind, randomized, multicenter, placebo-controlled, parallel-group study performed in 354 drug-naive patients with type 2 diabetes (T2DM) assessed efficacy and tolerability of vildagliptin (50 mg qd, 50 mg bid, or 100 mg qd). The primary assessment was change from baseline to endpoint in hemoglobin A1c (A1C), comparing vildagliptin to placebo by ANCOVA. Baseline A1C averaged 8.4% and the between-treatment difference (vildagliptin-placebo) in adjusted mean change (AM Delta) in A1C was -0.5 0.2% (P = 0.011), -0.7 +/- 0.2% (P < 0.001), and -0.9 +/- 0.2% (P < 0.001) in patients receiving vildagliptin 50 mg qd, 50 mg bid, or 100 mg qd, respectively. Baseline FPG averaged 10.5 mmol/L; the between-treatment difference in AM Delta FPG was -0.6 +/- 0.4 mmol/L in patients receiving vildagliptin 50 mg qd and -1.3 +/- 0.4 mmol/L (P = 0.001) in both groups receiving 100 mg daily. Relative to baseline, body weight did not change significantly in any of the three vildagliptin groups and decreased by 1.4 +/- 0.4 kg in the placebo group. Adverse events (AEs) occurred with similar frequency in each group: 55.8%, 59.3%, 59.3%, and 57.6% of patients receiving vildagliptin 50 mg qd, 50 mg bid, 100 mg qd, or placebo, respectively, experienced an AE. No confirmed hypoglycemia was reported.Conclusion: Vildagliptin is effective and well-tolerated in drug-naive patients with T2DM and 100 mg vildagliptin provides similar clinical benefit whether given as single or in divided doses. (c) 2007 Elsevier Ireland Ltd. All rights reserved.