The effects of ipragliflozin on the liver-to-spleen attenuation ratio as assessed by computed tomography and on alanine transaminase levels in Japanese patients with type 2 diabetes mellitus.

Abstract

We assessed the effects of a 12-week ipragliflozin treatment on the liver-to-spleen attenuation ratio (L/S ratio) using computed tomography and on alanine transaminase (ALT) levels in Japanese patients with type 2 diabetes mellitus (T2DM). Sixty-two patients with T2DM [age, 56±8years; hemoglobin A1c (HbA1c) levels, 8.1±0.9%; body mass index (BMI), 27.5±3.3kg/m2] were randomly assigned in a 2:1 ratio to receive ipragliflozin (50mg/day; ipragliflozin group; n=40) or continued treatment (control group; n=22) for 12weeks. The primary endpoints were changes in ALT levels; the secondary endpoints included changes in the L/S ratio and in the visceral fat area (VFA) and subcutaneous fat area (SFA) before and after 12weeks of the treatment as assessed by computed tomography. ALT levels (-12.45 vs. +5.82IU/l, P<0.001), L/S ratio (+0.07 vs. -0.08, P<0.001), SFA (-5.8 vs. +13.3cm2, P<0.05), and VFA (+1.4 vs. +20.4cm2, P<0.05) significantly changed from baseline in the ipragliflozin group compared with the values in the control group. Multiple regression analysis among all subjects revealed that the independent factor contributing to the %ΔALT and %ΔL/C ratio was treatment group alone (ipragliflozin group=1; control group=0; β coefficient=-32.08, P<0.001 and β coefficient=19.98, P<0.05, respectively). Thus, ipragliflozin may lower ALT levels associated with increased L/S ratios, indicating its potential therapeutic efficacy in T2DM-associated hepatic steatosis.