Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus:: A double-blind, randomized trial
Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus:: A double-blind, randomized trial
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DOI：
10.1210/jc.2003-030861
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发表时间：
2004-12-01
影响因子：
5.8
通讯作者：
Brunetti, P
中科院分区：
文献类型：
--
作者：
Schernthaner, G;Matthews, DR;Brunetti, P
吡格列酮增加外周组织的胰岛素敏感性，可能为2型糖尿病提供另一种一线治疗方法。这项研究比较了吡格列酮和二甲双胍治疗的2型糖尿病患者的代谢控制。控制不良的2型糖尿病1199例[糖化血红蛋白（HbA(1c)）], 7.5% - 11%；正常人（4.3 - 6.1%）随机接受吡格列酮（小于等于45 mg/d）或二甲双胍（小于等于850 mg，每日3次）治疗。测量HbA（1c）、空腹血糖（FPG）、胰岛素水平、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇、甘油三酯、游离脂肪酸、尿白蛋白/肌酐比值。从基线到第52周，两个治疗组的平均HbA1c均下降（- 1.4%和- 1.5%）。吡格列酮组（- 45.0 mg/dl; - 2.5 mmol/l）的FPG平均降低显著高于二甲双胍组（- 39.6 mg/dl; - 2.2 mmol/l） （P = 0.016）。吡格列酮组甘油三酯和HDL-C的有利变化更为明显。尽管低密度脂蛋白胆固醇和TC水平在吡格列酮治疗组中升高，但TC/HDL-C比值在两种治疗组中下降相似。吡格列酮组尿白蛋白/肌酐比值降低19%，但二甲双胍组保持不变（- 1%;P = 0.002）。吡格列酮组体重增加1.9 kg，二甲双胍组体重减少2.5 kg。不良事件的总体频率在治疗组之间相似，但不良事件概况在治疗组之间不同。吡格列酮和二甲双胍单药治疗后的HbA（1c）降低相似，但两种化合物在FPG、血脂和不良反应方面的差异可能会影响个体处方者的决策。
Pioglitazone increases the insulin sensitivity of peripheral tissues and may provide an alternative first-line treatment for type 2 diabetes. This study compared metabolic control in drug-naive type 2 diabetes patients given either pioglitazone or metformin. Eleven hundred and ninety-nine patients with poorly controlled type 2 diabetes mellitus [ glycosylated hemoglobin (HbA(1c)), 7.5 - 11%; normal, 4.3 - 6.1%] were randomized to receive either pioglitazone (less than or equal to 45 mg/d) or metformin (less than or equal to 850 mg, three times daily). HbA(1c), fasting plasma glucose (FPG), insulin levels, total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol, triglycerides, free fatty acids, and urinary albumin/ creatinine ratio were measured. Mean HbA1c decreased in both treatment groups from baseline to wk 52 (- 1.4% and - 1.5%). Significantly greater mean reductions in FPG were observed in the pioglitazone group ( - 45.0 mg/dl; - 2.5 mmol/ liter) than in the metformin ( - 39.6 mg/dl; - 2.2 mmol/liter) group ( P = 0.016). Favorable changes in triglycerides and HDL-C were more pronounced with pioglitazone. Although low density lipoprotein cholesterol and TC levels increased with pioglitazone, TC/HDL-C ratios decreased similarly with both treatments. The urinary albumin/creatinine ratio was reduced by 19% with pioglitazone treatment, but remained unchanged with metformin therapy ( - 1%; P = 0.002). There was an increase in body weight of 1.9 kg in the pioglitazone group and a decrease of 2.5 kg in the metformin group. The overall frequency of adverse events was similar between treatment groups, but adverse event profiles were different between treatment groups. HbA(1c) reduction is similar after pioglitazone and metformin monotherapies, but differences in FPG, plasma lipids, and adverse effects between the two compounds may influence decision-making in individual prescribers.