Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus.
Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus.
复制标题
DOI：
10.1007/s13300-014-0059-x
复制
发表时间：
2014-06
期刊：
影响因子：
3.8
通讯作者：
Suzuki, Manabu
中科院分区：
文献类型：
--
作者：
Odawara, Masato;Hamada, Izumi;Suzuki, Manabu
关键词：
本研究的目的是评价在日本2型糖尿病（T2 DM）患者中，作为二甲双胍添加治疗的一种强效二肽基肽酶-4抑制剂-维达鲁肽的疗效和安全性。这项多中心、12周、随机化、双盲、安慰剂对照、平行组研究在接受稳定日剂量二甲双胍单药治疗（250 mg bid或500 mg bid）后血糖控制不佳[糖化血红蛋白（HbA 1c）7.0-10.0%]的T2 DM患者中比较了维达鲁肽50 mg bid与安慰剂。共有139名患者随机接受维达列汀（n = 69）或安慰剂（n = 70）。基线时，两组患者的人口统计学资料相当。治疗12周后，维达鲁肽组HbA 1c的校正平均变化为−1.1%（基线8.0%），安慰剂组为−0.1%（基线8.0%），治疗间差异为−1.0%（P < 0.001）。在接受二甲双胍250 mg bid或500 mg bid的患者亚群中，维达西汀显示出相似的HbA 1c降低幅度，为-1.1%（与基线相比，P < 0.001）。与安慰剂组相比，维格鲁肽组中达到HbA 1c ≤6.5%（30.9%）和<7.0%（64.1%）目标的患者明显更多（P < 0.001）。空腹血糖的校正平均变化的治疗间差异为−1.6 mmol/L（P < 0.001），有利于维达鲁肽。vildagelide和安慰剂组的患者报告了相似的不良事件发生率（44.1% vs. 41.4%）。研究中未报告死亡或低血糖事件。在二甲双胍单药治疗血糖控制不佳的日本T2 DM患者中，二甲双胍加用维达利50 mg bid可改善血糖控制，且无任何耐受性问题和低血糖。本文的在线版本（doi：10.1007/s13300-014-0059-x）包含补充材料，可供授权用户使用。
The objective of this study was to evaluate the efficacy and safety of vildagliptin, a potent dipeptidyl peptidase-4 inhibitor, as an add-on to metformin in Japanese patients with type 2 diabetes mellitus (T2DM). This multicenter, 12-week, randomized, double-blind, placebo-controlled, parallel-arm study compared vildagliptin 50 mg bid with placebo in T2DM patients who were inadequately controlled [glycosylated hemoglobin (HbA1c) 7.0–10.0%] on a stable daily dose of metformin monotherapy (250 mg bid or 500 mg bid). A total of 139 patients were randomized to receive either vildagliptin (n = 69) or placebo (n = 70). Patient demographics were comparable between the groups at baseline. After 12 weeks of treatment, adjusted mean change in HbA1c was −1.1% in the vildagliptin group (baseline 8.0%) and −0.1% in the placebo group (baseline 8.0%), with a between-treatment difference of −1.0% (P < 0.001). Vildagliptin showed a similar reduction in HbA1c of −1.1% for both the subpopulations of patients receiving metformin 250 mg bid or 500 mg bid (P < 0.001 vs. baseline). Significantly more patients in the vildagliptin group achieved an HbA1c target of ≤6.5% (30.9%) and <7.0% (64.1%) compared with the placebo group (P < 0.001). The between-treatment difference in adjusted mean change in fasting plasma glucose was −1.6 mmol/L (P < 0.001) in favor of vildagliptin. Patients in the vildagliptin and placebo groups reported comparable incidences of adverse events (44.1% vs. 41.4%). No deaths or hypoglycemic events were reported in the study. Vildagliptin 50 mg bid added to metformin improved glycemic control without any tolerability issues and hypoglycemia in Japanese patients with T2DM inadequately controlled on metformin monotherapy. The online version of this article (doi:10.1007/s13300-014-0059-x) contains supplementary material, which is available to authorized users.
登录
查看更多内容
影响因子：
5.1
作者：
Pi-Sunyer, F. Xavier;Schweizer, Anja;Dejager, Sylvie
通讯作者：
Dejager, Sylvie
影响因子：
5.8
作者：
Seino, Y.;Miyata, Y.;Kaku, K.
通讯作者：
Kaku, K.
影响因子：
5.8
作者：
Bosi, E.;Dotta, F.;Goodman, M.
通讯作者：
Goodman, M.
影响因子：
5.1
作者：
Kikuchi, Masatoshi;Abe, Nobuyuki;Tachibana, Hideo
通讯作者：
Tachibana, Hideo
影响因子：
2.9
作者：
Schweizer, Anja;Dejager, Sylvie;Kothny, Wolfgang
通讯作者：
Kothny, Wolfgang