Fatty liver (FL) is a major complication of type 2 diabetes mellitus and has adverse effects on glycemic control. Although there are many reports on drug selection to improve FL (e.g., SGLT2 inhibitors), reports on drug selection considering the effects of the presence or degree of FL on glycemic control are scarce. To address this issue, we performed a post-hoc analysis of the results of the NISM study, a 52-week randomized controlled trial comparing the efficacy of Ipra and Sita. Included were 90 participants (58.9% male; 44 using Ipra; 46 using Sita). Mean age was 59.3 y and mean HbA1c 7.5%, BMI 26.6 kg/m2, ALT 30.7 U/L and FLI 51.1. Participants were stratified into low FLI (n=44, FLI <51.0) and high FLI (n=46, FLI ≥51.0) groups. In the low FLI group, HbA1c improved significantly with Sita compared with Ipra (Ipra 0.37 vs. Sita -0.68, p = 0.04). On the other hand, in the high FLI group, HbA1c improved significantly with Ipra compared with Sita (Ipra -0.63 vs. Sita -0.14, p = 0.04). There was no difference in changes in the FLI in the low FLI group (-8.1 vs. -2.7, p = 0.051), but in the high FLI group, FLI improved significantly (-13.5 vs. -0.8, p <0.001) with Ipra compared with Sita. The FLI is effective in drug selection for type 2 diabetes.
M. Kitazawa: None. H. Sone: Research Support; Novo Nordisk, Astellas Pharma Inc., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Eisai Inc., Sumitomo Dainippon Pharma Co., Ltd. K. Fujihara: None. T. Yamada: None. Y. Matsubayashi: None. M. Ishizawa: None. H. Suzuki: None. M. Yamamoto: None. M.H. Yamada: None. M. Hatta: None.
This study was funded by Astellas Pharma Inc. The company was not involved in study design, patient selection, data aggregation/analysis, interpretation of results, or preparation of the manuscript.
