Background: In some large-scale clinical trials, the administration of sodium glucose co-transporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM) has revealed pronounced and consistently beneficial renal outcome. However, it is unclear whether long term SGLT2i administration led to similar results in Japanese T2DM patients. Objective: To elucidate the renal effects of long term SGLT2i administration in Japanese T2DM patients with chronic kidney disease (CKD).
Method: Data from T2DM patients with CKD who were visiting members of Kanagawa Physicians Association and being administered SGLT2i for more than 1 year were used.
Result: We analyzed 753 patients. Six SGLT2i types were used with median administration period of 33.0 months. The mean albumin-to-creatinine ratio (ACR) significantly decreased from 36.0 to 27.5 (mg/gCr, p<0.01). Based on intensity, the mean ACR value significantly decreased from 72.1 to 54.8 in microalbuminuric patients (n=288) and from 625.1 to 414.1 in macroalbuminuric patients (n=58) (p<0.01); however, it did not change in normoalbuminuric patients (n=275). Multiple linear regression analysis revealed that the localized ACR baseline value, change (Δ) in systolic and diastolic BP, and ΔHbA1c were independently correlated with ΔACR; values of these regression coefficients were -0.21, 0.01, 0.01, and 0.08, respectively (p<0.01). The eGFR decreased from 77.5±22.2 to 72.7±22.4 mL/min/1.73 m2 (p<0.01). The localized ACR baseline value, ΔBW, age, baseline eGFR, treatment duration, and baseline diastolic BP were independently correlated with ΔeGFR; the regression coefficients were -1.35, -0.42, -0.24, -0.23,-0.11, and -0.08, respectively (p<0.01).
Conclusion: This study confirmed that the improvement of ACR was also observed in the real world; however, eGFR gradually decreased after long term SGLT2i administration. The relationship between background factors should be further discussed in future.
K. Kobayashi: None. M. Toyoda: Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kyowa Hakko Kirin Co., Ltd., Medtronic Japan Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. N. Hatori: None. H. Sakai: None. T. Furuki: None. K. Tamura: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca, Ono Pharmaceutical Co., Ltd. Speaker's Bureau; Self; AstraZeneca, Ono Pharmaceutical Co., Ltd. M. Miyakawa: None.