Agrawal Arvind, Sautter Maureen C, Jones Nigel P
Clinical Development and Medical Affairs--Cardiovascular, Urology, and Metabolism, GlaxoSmithKline, Harlow, Essex, United Kingdom.
Clin Ther. 2003 Nov;25(11):2754-64. doi: 10.1016/s0149-2918(03)80331-4.
Patients with type 2 diabetes mellitus (DM) and renal impairment whose disease is inadequately controlled on a sulfonylurea (SU) have limited oral combination treatment options.
This post hoc analysis assesses the efficacy and tolerability of the insulin sensitizer rosiglitazone maleate (RSG) when added to an SU treatment regimen in patients with type 2 DM with mild to moderate renal impairment that is inadequately controlled by SU monotherapy.
Data were pooled from 3 randomized, double-blind, placebo-controlled, parallel-group studies in which RSG or placebo was added to an SU (glibenclamide, gliclazide, or glipizide) treatment regimen for a period of 6 months. Patients were subcategorized as having mild to moderate renal impairment or normal renal function based on a baseline creatinine clearance rate of 30 to 80 mL/min or >80 mL/min, respectively, as estimated by the Cockcroft-Gault equation.
The population studied comprised 824 patients, 62% men and 38% women, aged 32 to 81 years, of whom 301 had mild to moderate renal impairment and 523 had normal renal function. In patients with and without renal impairment, glycemia was improved in the SU + RSG-treated group compared with the SU + placebo-treated group. The observed treatment differences between the groups were -2.6 mmol/L for fasting plasma glucose and -1.1% for glycosylated hemoglobin (for both renally impaired and nonimpaired patients). For patients receiving SU + RSG, little difference in the safety profile was found between patients with and without renal impairment.
RSG was effective and well tolerated when added to SU therapy in this population of patients with mild to moderate renal impairment.
2型糖尿病（DM）合并肾功能损害且使用磺脲类药物（SU）治疗效果不佳的患者，口服联合治疗方案有限。
本事后分析评估了在单用SU治疗控制不佳的轻度至中度肾功能损害的2型糖尿病患者中，添加胰岛素增敏剂马来酸罗格列酮（RSG）至SU治疗方案时的疗效和耐受性。
数据来自3项随机、双盲、安慰剂对照、平行组研究，其中RSG或安慰剂被添加至SU（格列本脲、格列齐特或格列吡嗪）治疗方案中，为期6个月。根据Cockcroft-Gault方程估算的基线肌酐清除率，分别将患者分为轻度至中度肾功能损害（30至80 mL/min）或肾功能正常（>80 mL/min）亚组。
研究人群包括824例患者，年龄32至81岁，男性占62%，女性占38%，其中301例有轻度至中度肾功能损害，523例肾功能正常。在有和无肾功能损害的患者中，与SU+安慰剂治疗组相比，SU+RSG治疗组的血糖得到改善。两组间观察到的治疗差异为空腹血糖-2.6 mmol/L，糖化血红蛋白-1.1%（肾功能损害和未损害患者均如此）。对于接受SU+RSG治疗的患者，有和无肾功能损害患者的安全性概况差异不大。
在该轻度至中度肾功能损害患者人群中，RSG添加至SU治疗有效且耐受性良好。
