The STELLA-LONG TERM prospective post-marketing surveillance study assessed ipragliflozin in Japanese patients with type 2 diabetes mellitus (T2DM). This subgroup analysis of patients with liver impairment used the final 3-year results. Data on patients, adverse drug reactions (ADRs), and changes in glycemic parameters and liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [γ-GTP] and alkaline phosphatase [ALP]) were collected, and the fatty liver index (FLI) was calculated. In the effectiveness analysis (n = 8,763), baseline liver function was normal in 2,605 patients (ALT <31/<21 U/L [men/women]) and abnormal in 3,277 (ALT ≥31/≥21 U/L). The abnormal liver function group had higher mean body weight and BMI than the normal liver function group (p < 0.001). In the safety analysis (n = 11,051), urinary tract infections, genital infections and hepatic disorders were more common in the abnormal than normal liver function group (2.25% vs. 1.07%; 1.78% vs. 1.14% and 1.85% vs. 1.01%). In the abnormal liver function group, there were significant (p < 0.001) decreases from baseline at 36 months in AST and ALT (from 38.8 and 53.7 U/L to 29.3 and 37.7 U/L, respectively), γ-GTP (from 75.4 to 51.7 U/L) and ALP (from 254.8 to 234.5 U/L), which were greater than in the normal liver function group. FLI reductions at 36 months were significant (p < 0.001) in subgroups with baseline FLI of ≥30 or ≥60. In conclusion, ipragliflozin improved liver function over 3 years in patients with impaired liver function, although ADRs occurred more frequently than in the normal liver function group.

STELLA-LONG TERM 前瞻性上市后监测研究评估了 ipragliflozin 在日本 2 型糖尿病 (T2DM) 患者中的疗效。对肝功能损害患者的亚组分析使用了最终的 3 年结果。收集有关患者、药物不良反应 (ADR) 以及血糖参数和肝酶（天冬氨酸氨基转移酶 [AST]、丙氨酸氨基转移酶 [ALT]、γ-谷氨酰转肽酶 [γ-GTP] 和碱性磷酸酶 [ALP]）变化的数据, 并计算脂肪肝指数 (FLI)。在有效性分析 ( n = 8,763) 中，2,605 名患者的基线肝功能正常（ALT <31/<21 U/L [男性/女性]），3,277 名患者的基线肝功能异常（ALT ≥31/≥21 U/L）。肝功能异常组的平均体重和BMI高于肝功能正常组（p < 0.001)。在安全性分析（n = 11,051）中，尿路感染、生殖器感染和肝脏疾病在肝功能异常组中比正常组更常见（2.25% vs. 1.07%；1.78% vs. 1.14% 和 1.85% vs. 1.01 %）。在肝功能异常组中， 36 个月时 AST 和 ALT（分别从38.8和 53.7 U/L 降至 29.3 和 37.7 U/L）、γ-GTP（从 75.4至 51.7 U/L）和 ALP（从 254.8 至 234.5 U/L），均高于肝功能正常组。36 个月时 FLI 减少显着（p< 0.001) 在基线 FLI ≥30 或 ≥60 的亚组中。总之，ipragliflozin 在肝功能受损患者中改善了 3 年以上的肝功能，尽管 ADR 的发生频率高于肝功能正常组。