Rosenstock J, Chou H S, Matthaei S, Seidel D K, Hamann A
Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
Diabetes Obes Metab. 2008 Sep;10(10):862-73. doi: 10.1111/j.1463-1326.2007.00815.x. Epub 2008 Jan 14.
To assess the efficacy and tolerability of early combination therapy with rosiglitazone (RSG) and glimepiride (GLIM) vs. GLIM monotherapy in patients with type 2 diabetes mellitus (T2DM).
Strategies for the addition of RSG in combination with GLIM were evaluated with data from two randomized, double-blind, placebo (PBO)-controlled studies. Study A - addition of RSG (4 or 8 mg) or PBO to continued GLIM 3 mg once daily; study B - addition of low-dose RSG (4 mg) prior to uptitration of GLIM (from 2 to 4 mg) vs. continued uptitration of GLIM (from 2 to 8 mg).
Study A reported significant reductions in fasting plasma glucose (FPG) from baseline to week 26 with the addition of both 4 and 8 mg RSG to GLIM 3 mg [-21 mg/dl (-1.2 mmol/l), p = 0.0019 and -43 mg/dl (-2.4 mmol/l), p < 0.0001, respectively] and in haemoglobin A(1c) (HbA(1c)) (-0.63%, p = 0.00015 and -1.17%, p < 0.0001, respectively) from a baseline of 8.2 and 8.1%, respectively. At the end of the study, target HbA(1c) <7.0% was achieved in 43 and 68% of patients in the RSG 4 mg + GLIM and RSG 8 mg + GLIM groups, respectively, compared with 32% in the PBO + GLIM (GLIM alone) group. In study B, addition of RSG to GLIM reduced mean FPG and HbA(1c) levels at week 24 from baseline [-28 mg/dl (-1.5 mmol/l), p < 0.0001, and -0.68%, p < 0.0001, respectively]. There were no significant changes with GLIM monotherapy in either study. Favourable effects of RSG + GLIM on insulin sensitivity, beta-cell function and cardiovascular disease biomarkers were also observed. All treatments were similarly well tolerated.
Early addition of RSG to GLIM is an effective and well-tolerated treatment option to improve glycaemic control in sulphonylurea-treated patients with T2DM.
评估罗格列酮（RSG）与格列美脲（GLIM）早期联合治疗对比GLIM单药治疗2型糖尿病（T2DM）患者的疗效和耐受性。
采用两项随机、双盲、安慰剂（PBO）对照研究的数据，评估RSG联合GLIM的添加策略。研究A——在继续每日一次服用3 mg GLIM的基础上加用RSG（4或8 mg）或PBO；研究B——在GLIM滴定上调（从2 mg至4 mg）之前加用低剂量RSG（4 mg）与继续GLIM滴定上调（从2 mg至8 mg）进行对比。
研究A报告，在3 mg GLIM基础上加用4 mg和8 mg RSG后，从基线至第26周空腹血糖（FPG）显著降低[-21 mg/dl（-1.2 mmol/l），p = 0.0019；-43 mg/dl（-2.4 mmol/l），p < 0.0001]，糖化血红蛋白（HbA(1c)）分别从基线的8.2%和8.1%显著降低（-0.63%，p = 0.00015；-1.17%，p < 0.0001）。在研究结束时，RSG 4 mg + GLIM组和RSG 8 mg + GLIM组分别有43%和68%的患者达到目标HbA(1c) <7.0%，而PBO + GLIM（仅GLIM）组为32%。在研究B中，GLIM加用RSG使第24周时的平均FPG和HbA(1c)水平较基线降低[-28 mg/dl（-1.5 mmol/l），p < 0.0001；-0.68%，p < 0.0001]。两项研究中GLIM单药治疗均无显著变化。还观察到RSG + GLIM对胰岛素敏感性、β细胞功能和心血管疾病生物标志物有有利影响。所有治疗的耐受性相似。
在GLIM基础上早期加用RSG是一种有效且耐受性良好的治疗选择，可改善磺脲类治疗的T2DM患者的血糖控制。
