Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial - a primary care, type 2 diabetes study
Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial - a primary care, type 2 diabetes study
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DOI：
10.1111/j.1463-1326.2009.01080.x
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发表时间：
2009-10-01
影响因子：
5.8
通讯作者：
Baron, M.
中科院分区：
文献类型：
--
作者：
Blonde, L.;Dagogo-Jack, S.;Baron, M.
目的评估与噻唑烷二酮类药物（TZDs）相比，在二甲双胍治疗基础护理的2型糖尿病患者人群中，维达鲁肽的疗效和耐受性。（100 mg，n = 1653）和TZD（药物和剂量由研究者决定，n = 825）控制不佳患者的添加治疗[血红蛋白A（1C）（HbA（1c））：7-10%]服用稳定剂量的二甲双胍（>= 1000 mg/天）。主要目的是检验维达鲁肽相对于TZD在HbA（1c）从基线的变化差异方面的非劣效性[如果双侧95%置信区间（CI）的上限不超过0.4%则建立]。从基线到研究终点的HbA（1c）变化在维达鲁肽组为-0.68 +/- 0.02%，在TZD组为-0.57 +/- 0.03%。治疗3个月后，组间差异为-0.11%（95% CI：-0.17%和-0.04%），确立了维达利的非劣效性（p = 0.001）。在人种、年龄和体重指数亚组中，维达利不劣于TZD。TZD组的体重增加（0.33 +/- 0.11 kg），而维格鲁肽组的体重降低（平均值：-0.58 +/- 0.09 kg;差异p < 0.001）。两组患者发生不良事件的比例相似（维格列汀：39.5%和TZD：36.3%）低血糖和肝酶异常变化并不常见。结论这项短期研究表明，维格列汀在治疗3个月后与TZD一样有效，作为初级保健人群（包括不同患者亚组）中二甲双胍的添加治疗。
AimTo assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes.MethodsThis was a randomized, 12-week, open-label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators' discretion, n = 825) add-on therapy in patients inadequately controlled [haemoglobin A(1C) (HbA(1c)): 7-10%] on a stable dose of metformin (>= 1000 mg/day). The primary objective was to test non-inferiority of vildagliptin to TZDs for the difference in change in HbA(1c) from baseline [established if the upper limit of the two-sided 95% confidence intervals (CI) did not exceed 0.4%].ResultsMean (+/- s.e.) change in HbA(1c) from baseline to study endpoint was -0.68 +/- 0.02% in the vildagliptin group and -0.57 +/- 0.03% in the TZD group. The difference between groups was -0.11% (95% CI: -0.17% and -0.04%), establishing the non-inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non-inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 +/- 0.11 kg) and decreased in the vildagliptin group (mean: -0.58 +/- 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5% and TZD: 36.3%) Hypoglycaemia and abnormal changes in liver enzymes were uncommon.ConclusionsThis short-term study suggests that vildagliptin is as effective as TZDs after 3-month treatment as an add-on to metformin in a primary care population that included diverse patient subgroups.