Influence of Renal Function on the 52-Week Efficacy and Safety of the Sodium Glucose Cotransporter 2 Inhibitor Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus
Influence of Renal Function on the 52-Week Efficacy and Safety of the Sodium Glucose Cotransporter 2 Inhibitor Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus
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DOI：
10.1016/j.clinthera.2015.10.025
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发表时间：
2016-01-01
影响因子：
3.2
通讯作者：
Samukawa, Yoshishige
中科院分区：
文献类型：
--
作者：
Haneda, Masakazu;Seino, Yutaka;Samukawa, Yoshishige
目的：评价肾功能对糖共转运蛋白2钠抑制剂鲁西格列净（TS-071）治疗日本2型糖尿病（T2DM）患者疗效和安全性的影响。方法：研究1是一项为期52周的fa期研究，旨在评估2.5 mg/d鲁西格列净（或增加至5 mg/d）治疗伴有中度肾功能损害的T2DM患者的有效性和安全性。在最初的24周内，将鲁西格列净的疗效和安全性与安慰剂进行比较。研究2是对包括研究1在内的4项为期52周的luseoglilozin III期研究的汇总分析，以评估luseoglilozin对不同程度肾功能患者的疗效和安全性。根据基线估计肾小球滤过率（eGFR）将患者分为3组：正常肾功能组（>= 90 mL/min/1.73 m(2)）、轻度肾功能损害组（>= 60 ~ = 30 ~ = 45 ~ < 60 mL/min/1.73 m(2)）和中重度肾功能损害组(>= 30 ~
Purpose: To evaluate the influence of renal function on the efficacy and safety of the sodium glucose cotransporter 2 inhibitor luseogliflozin (TS-071) in Japanese patients with type 2 diabetes mellitus (T2DM).Methods: Study 1 was a 52-week, Phase fa study to evaluate the efficacy and safety of 2.5 mg/d luseogliflozin (or increased to 5 mg/d) in patients with T2DM with moderate renal impairment. During the initial 24 weeks, efficacy and safety of luseogliflozin were compared with placebo. Study 2 was a pooled analysis of four 52-week, Phase III studies of luseogliflozin, including Study 1, to evaluate the efficacy and safety of luseogliflozin in patients with various degrees of renal function. Patients were stratified into 3 groups by baseline estimated glomerular filtration rate (eGFR): normal renal function (>= 90 mL/min/1.73 m(2)), mild impairment (>= 60 to = 30 to = 45 to < 60 mL/min/1.73 m(2)) and moderate-severe (>= 30 to