The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.
Department of Endocrinology and Metabolism, Yokohama City University, Yokohama, Japan.
J Diabetes Investig. 2020 Sep;11(5):1248-1257. doi: 10.1111/jdi.13248. Epub 2020 Apr 25.
AIMS/INTRODUCTION: Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available.
This was an investigator-initiated multicenter prospective intervention study in which ipragliflozin (50 mg) was administered once daily, and glycemic control, estimated glomerular filtration rate (eGFR) and adverse events were evaluated until 104 weeks after starting research.
There were 407 patients analyzed. In the eGFR ≥90 group and eGFR ≥60 to <90 group, eGFR had significantly decreased compared with baseline at all time points from 4 to 104 weeks. There were significant increases in the eGFR ≥45 to <60 groups compared with baseline at 36 weeks (2.3 ± 1.0) and 52 weeks (2.6 ± 1.2). Comparison between the eGFR <60, urine albumin-to-creatinine ratio >300 group and the eGFR <60, urine albumin-to-creatinine ratio <300 group showed a greater reduction in eGFR in the former (-5.4 ± 2.4 vs 3.3 ± 1.1) at 12 weeks and was maintained to 104 weeks. In any group, eGFR did not significantly decrease until 104 weeks compared with 4 weeks. The urine albumin-to-creatinine ratio after 52 weeks and after 104 weeks was significantly decreased compared with baseline in the eGFR ≥90 group.
Ipragliflozin lowers eGFR and corrects hyperfiltration in patients with high eGFR (eGFR ≥60). In patients with low eGFR (eGFR ≥30 to <60), ipragliflozin has the possibility of increasing eGFR and exerting a renoprotective effect.
目的/引言：2 型糖尿病是全球导致肾衰竭的主要原因，但目前可用的有效长期治疗方法很少。
这是一项由研究者发起的多中心前瞻性干预研究，在该研究中，给予患者每日一次伊格列净（50mg）治疗，并评估血糖控制、估算肾小球滤过率（eGFR）和不良事件，直至开始研究后 104 周。
共分析了 407 例患者。在 eGFR≥90 组和 eGFR≥60 至<90 组中，从第 4 周到第 104 周，eGFR 与基线相比在所有时间点均显著下降。与基线相比，eGFR≥45 至<60 组在 36 周（2.3±1.0）和 52 周（2.6±1.2）时显著增加。eGFR<60、尿白蛋白/肌酐比值>300 组与 eGFR<60、尿白蛋白/肌酐比值<300 组之间的比较显示，前者在第 12 周时 eGFR 下降更明显（-5.4±2.4 对 3.3±1.1），并且这种情况一直持续到第 104 周。在任何一组中，与第 4 周相比，eGFR 在第 104 周时均未显著下降。eGFR≥90 组患者在第 52 周和第 104 周时的尿白蛋白/肌酐比值与基线相比均显著下降。
伊格列净降低了高 eGFR（eGFR≥60）患者的 eGFR，并纠正了高滤过。在低 eGFR（eGFR≥30 至<60）患者中，伊格列净有可能增加 eGFR，发挥肾脏保护作用。
