Jin S-M, Park C-Y, Cho Y M, Ku B J, Ahn C W, Cha B-S, Min K W, Sung Y A, Baik S H, Lee K W, Yoon K-H, Lee M-K, Park S W
Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Endocrinology and Metabolism, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Diabetes Obes Metab. 2015 Jun;17(6):599-602. doi: 10.1111/dom.12435. Epub 2015 Feb 8.
We aimed to compare the efficacy and safety of lobeglitazone and pioglitazone as add-ons to metformin in patients with type 2 diabetes. Patients who were inadequately controlled by metformin were randomized and treated once daily with either lobeglitazone (0.5 mg, n = 128) or pioglitazone (15 mg, n = 125) for 24 weeks, with a 28-week extension trial of lobeglitazone treatment in patients who consented. The primary endpoint was the change in glycated haemoglobin (HbA1c) concentration from baseline to week 24. At week 24, the mean change from baseline in HbA1c was -0.74% for the lobeglitazone group and -0.74% for the pioglitazone group, with a mean difference of 0.01% [95% confidence interval (CI) of difference, -0.16 to 0.18]. The effects of lobeglitazone on lipid variables and the adverse events associated with lobeglitazone were similar to those observed with pioglitazone. Lobeglitazone was not inferior to pioglitazone as an add-on to metformin in terms of their efficacy and safety.
我们旨在比较在2型糖尿病患者中，洛格列酮和吡格列酮作为二甲双胍附加治疗药物的疗效和安全性。二甲双胍治疗效果不佳的患者被随机分组，每天服用一次洛格列酮（0.5毫克，n = 128）或吡格列酮（15毫克，n = 125），为期24周，对同意参加的患者进行为期28周的洛格列酮延长治疗试验。主要终点是糖化血红蛋白（HbA1c）浓度从基线到第24周的变化。在第24周时，洛格列酮组HbA1c较基线的平均变化为-0.74%，吡格列酮组为-0.74%，平均差异为0.01%[差异的95%置信区间（CI），-0.16至0.18]。洛格列酮对血脂变量的影响以及与洛格列酮相关的不良事件与吡格列酮观察到的相似。在疗效和安全性方面，洛格列酮作为二甲双胍的附加治疗药物并不逊于吡格列酮。
