Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Edogawa-Ku, Tokyo, Japan.
PLoS One. 2023 Sep 21;18(9):e0292014. doi: 10.1371/journal.pone.0292014. eCollection 2023.
The changes in the estimated glomerular filtration rate (eGFR) and predictors of the renal prognosis were retrospectively assessed over the 12 months after the initiation of tofogliflozin, which has the shortest half-life among sodium-glucose cotransporter 2 (SGLT2) inhibitors, in Japanese patients with type 2 diabetes and renal impairment.
In total, 158 patients treated with tofogliflozin between 2019 and 2021 were studied as the safety analysis set. One hundred and thirty subjects whose medication was continued over 12 months were investigated as the full analysis set. The subjects were divided into two groups based on the eGFR: normal- (eGFR ≥60 mL/min/1.73 m2, n = 87) and low- (eGFR <60 mL/min/1.73 m2, n = 43) eGFR groups.
The body weight, blood pressure, urinary protein excretion, and serum uric acid concentration decreased from baseline in both eGFR groups while the hemoglobin level increased. The eGFR did not significantly differ over time, except for the initial dip (-4.3±9.6 mL/min/1.73 m2 in the normal-eGFR group and -1.5±5.3 mL/min/1.73 m2 in the low-eGFR group). The change in the eGFR at 12 months after the initiation of tofogliflozin was -1.9±9.0 mL/min/1.73 m2 and 0.2±6.0 mL/min/1.73 m2 in the normal- and low-eGFR group, respectively. In the normal-eGFR group, the change in the eGFR showed a significant negative correlation with the HbA1c and eGFR at baseline, according to a multiple regression analysis. In the low-eGFR group, the change in the eGFR showed a significant negative correlation with urate-lowering agent use. The frequencies of adverse events specific for SGLT2 inhibitors were not significantly different between the normal- and low-eGFR groups.
Tofogliflozin may preserve renal function in the medium term in patients with type 2 diabetes and kidney impairment without an increase in specific adverse events.
在开始使用托格列净后 12 个月内，对其半衰期在钠-葡萄糖协同转运蛋白 2（SGLT2）抑制剂中最短的日本 2 型糖尿病和肾功能受损患者的估算肾小球滤过率（eGFR）变化和肾脏预后预测因素进行了回顾性评估。
总共对 2019 年至 2021 年间使用托格列净治疗的 158 名患者进行了安全性分析。对 130 名连续用药 12 个月的患者进行了全分析集调查。根据 eGFR 将受试者分为两组：正常（eGFR≥60mL/min/1.73m2，n=87）和低（eGFR<60mL/min/1.73m2，n=43）eGFR 组。
两组 eGFR 患者的体重、血压、尿蛋白排泄量和血尿酸浓度均较基线下降，血红蛋白水平升高。除初始下降外（正常 eGFR 组为-4.3±9.6mL/min/1.73m2，低 eGFR 组为-1.5±5.3mL/min/1.73m2），eGFR 随时间无显著差异。托格列净治疗 12 个月后，eGFR 的变化分别为正常 eGFR 组-1.9±9.0mL/min/1.73m2和低 eGFR 组 0.2±6.0mL/min/1.73m2。在正常 eGFR 组中，根据多元回归分析，eGFR 的变化与基线时的 HbA1c 和 eGFR 呈显著负相关。在低 eGFR 组中，eGFR 的变化与降尿酸药物的使用呈显著负相关。正常 eGFR 组和低 eGFR 组之间，SGLT2 抑制剂特有的不良事件频率无显著差异。
托格列净在不增加特定不良事件的情况下，可能在中期保护 2 型糖尿病和肾功能受损患者的肾功能。
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