Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes
Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes
复制标题
DOI：
10.1002/dmrr.264
复制
发表时间：
2002-03-01
影响因子：
8
通讯作者：
Gould, EM
中科院分区：
文献类型：
--
作者：
Gómez-Perez, FJ;Fanghänel-Salmón, G;Gould, EM
背景2型糖尿病在墨西哥是一个日益严重的问题。本研究是进行评估的有效性和安全性罗格列酮2毫克或4毫克，每日两次（BD）与二甲双胍2.5克/天的组合在墨西哥的2型糖尿病患者的控制不充分，二甲双胍单.Methods这个随机，双盲，安慰剂对照研究在墨西哥的四个中心进行。共116例患者随机分为二甲双胍2.5g/d+安慰剂组（n = 39），二甲双胍2.5g/d+罗格列酮2 mg bd组（n = 37），或二甲双胍2.5 g/d+罗格列酮4 mg bd（n = 40）治疗26周。罗格列酮2 mg bd组水平从基线至第26周显著降低（-0.7%; p = 0.0052）和4 mg bd（-1.2%; p = 0.0008）组，但安慰剂组增加（+0.3%; P=0.2651）。二甲双胍联合罗格列酮治疗组与安慰剂组相比，平均空腹血糖和果糖胺水平也以剂量顺序方式显著改善（分别为p ≤ 0.0019和p = 0.0006）。两个罗格列酮组的C肽和免疫反应性胰岛素水平均较基线降低。尽管在罗格列酮组中观察到总胆固醇、低密度脂蛋白（LDL）-胆固醇和高密度脂蛋白（HDL）-胆固醇的平均增加，但总胆固醇：HDL-胆固醇比值保持不变。所有三组中发生一次或多次不良事件的患者比例相似。没有肝toxicity.Conclusion罗格列酮2 mg BD和4 mg BD二甲双胍治疗改善墨西哥患者的血糖控制不充分的2型糖尿病单用二甲双胍控制。此外，罗格列酮联合二甲双胍的耐受性良好。版权所有（C）2002约翰威利父子有限公司
Background Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled with metformin alone.Methods This randomized, double-blind, placebo-controlled study was conducted at four centers in Mexico. A total of 116 patients were randomized to metformin 2.5 g/day plus placebo (n = 39), metformin 2.5 g/day plus rosiglitazone 2 mg bd (n = 3 7), or metformin 2.5 g/day plus rosiglitazone 4 mg bd (n = 40) for 26 weeks.Results Mean hemoglobin A(1c) (HbA(1c)) levels decreased significantly from baseline to Week 26 in the rosiglitazone 2 mg bd (-0.7%; p = 0.0052) and 4 mg bd (-1.2%; p = 0.0008) groups, but increased in the placebo group (+0.3%; P=0.2651). Mean fasting plasma glucose and fructosamine levels also improved significantly with metformin plus rosiglitazone therapy in a dose-ordered manner compared with placebo (p less than or equal to 0.0019 and p = 0.0006, respectively). C-peptide and immunoreactive insulin levels were decreased from baseline in both rosiglitazone groups. Although mean increases in total cholesterol, low-density lipoprotein (LDL) -cholesterol, and high-density lipoprotein (HDL)-cholesterol were observed in the rosiglitazone groups, the total cholesterol: HDL-cholesterol ratio remained unchanged. The proportion of patients with one or more adverse events was similar across all three groups. There were no cases of hepatotoxicity.Conclusion Addition of rosiglitazone 2 mg bd and 4 mg bd to metformin therapy improved glycemic control in Mexican patients whose type 2 diabetes was inadequately controlled by metformin alone. Furthermore, the combination of rosiglitazone plus metformin was well tolerated. Copyright (C) 2002 John Wiley Sons, Ltd.