Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Edogawa, Tokyo, Japan.
PLoS One. 2021 Mar 15;16(3):e0248577. doi: 10.1371/journal.pone.0248577. eCollection 2021.
The safety and efficacy, particularly, the factors associated with the renal prognosis, were assessed over 12 months after the initiation of luseogliflozin therapy in Japanese patients with type 2 diabetes and renal impairment.
In total, 238 patients treated with luseogliflozin (2.5 mg, once daily) were studied as the safety analysis set. Two hundred and two subjects whose medication was continued over 12 months were investigated as the full analysis set. The subjects were divided into 3 groups based on the estimated glomerular filtration rate (eGFR): high eGFR (n = 49), normal eGFR (n = 116) and low eGFR (n = 37) groups.
The body weight, systolic blood pressure, HbA1c and urinary protein excretion gradually decreased from baseline in all eGFR groups. While the eGFR was significantly reduced from baseline in the high and normal eGFR groups, the eGFR did not significantly differ over time in the low eGFR group. There was no marked difference in the frequency of adverse events that were specific for SGLT2 inhibitors among the 3 groups in the safety analysis set.
Luseogliflozin can preserve the renal function in the medium term in patients with type 2 diabetes and renal impairment without an increase in specific adverse events.
评估在患有 2 型糖尿病和肾功能损害的日本患者开始使用卢格列净治疗 12 个月后,其安全性和疗效,特别是与肾脏预后相关的因素。
共有 238 名接受卢格列净(2.5mg,每日一次)治疗的患者被纳入安全性分析集。202 名药物治疗持续 12 个月的患者被纳入全分析集进行研究。根据估计肾小球滤过率(eGFR)将患者分为 3 组:高 eGFR 组(n=49)、正常 eGFR 组(n=116)和低 eGFR 组(n=37)。
在所有 eGFR 组中,体重、收缩压、HbA1c 和尿蛋白排泄量均从基线逐渐下降。高和正常 eGFR 组的 eGFR 从基线显著下降,而低 eGFR 组的 eGFR 随时间无明显差异。在安全性分析集中,3 组之间 SGLT2 抑制剂特有的不良事件发生率没有明显差异。
卢格列净可在中期保护 2 型糖尿病和肾功能损害患者的肾功能,且不会增加特定的不良事件。