Weng Meng-Tzu, Yang Po-Jen, Liu Pan-Fu, Chang Chin-Hao, Lee Hsuan-Shu, Sheu Jin-Chuan, Nien Hsiao-Ching
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Department of Medical Research, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.
Hepatol Int. 2025 Apr;19(2):405-414. doi: 10.1007/s12072-024-10758-3. Epub 2024 Dec 3.
BACKGROUND/AIMS: Nonalcoholic fatty liver disease (NAFLD) is a common liver comorbidity with considerable global consequences. This study explores the efficacy of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor primarily used to manage type 2 diabetes, in reducing liver steatosis among NAFLD patients.
This randomized, open-label, two-arm, parallel-group trial enrolled patients with NAFLD and a controlled attenuation parameter (CAP) score of ≥ 252 dB/m. Participants were randomized (1:1) into either the control or dapagliflozin groups. The primary outcome was the change in CAP scores, measured with FibroScan after 24 weeks.
The trial included 150 patients, 20 of whom (13%) had type 2 diabetes. In week 24, the dapagliflozin group had significantly lower CAP score and fatty liver grade than did the control group (266.3 ± 57.8 50 vs 298.6 ± 59.0 dB/m, respectively [p = 0.002]; 1.7 ± 0.7 vs 2.2 ± 0.8, respectively [p < 0.001]). Liver stiffness, waist circumference, and alanine transaminase levels decreased in both the dapagliflozin and control groups, but the between-group differences were nonsignificant (1.0 ± 0.3 vs 1.1 ± 0.3 [p = 0.678], 94.2 ± 12.7 vs 92.4 ± 11.1 [p = 0.382], and 28.8 ± 18.3 vs 28.3 ± 14.2 U/L [p = 0.856], respectively). In the multivariate analysis, a reduction in CAP was associated with dapagliflozin treatment (p = 0.01) and changes in BMI (p = 0.007). No adverse events were observed.
Dapagliflozin can reduce CAP score and fatty liver grade in patients with moderate to severe NAFLD, regardless of their diabetes status.
背景/目的：非酒精性脂肪性肝病（NAFLD）是一种常见的肝脏合并症，在全球范围内具有相当大的影响。本研究探讨了主要用于治疗2型糖尿病的钠-葡萄糖协同转运蛋白2抑制剂达格列净在降低NAFLD患者肝脏脂肪变性方面的疗效。
这项随机、开放标签、双臂、平行组试验纳入了NAFLD患者，其控制衰减参数（CAP）评分≥252dB/m。参与者被随机（1:1）分为对照组或达格列净组。主要结局是24周后用FibroScan测量的CAP评分变化。
该试验纳入了150名患者，其中20名（13%）患有2型糖尿病。在第24周时，达格列净组的CAP评分和脂肪肝分级显著低于对照组（分别为266.3±57.8与298.6±59.0dB/m [p = 0.002]；分别为1.7±0.7与2.2±0.8 [p < 0.001]）。达格列净组和对照组的肝脏硬度、腰围和丙氨酸转氨酶水平均有所下降，但组间差异无统计学意义（分别为1.0±0.3与1.1±0.3 [p = 0.678]，94.2±12.7与92.4±11.1 [p = 0.382]，以及28.8±18.3与28.3±14.2 U/L [p = 0.856]）。在多变量分析中，CAP的降低与达格列净治疗（p = 0.01）和体重指数变化（p = 0.007）相关。未观察到不良事件。
达格列净可降低中度至重度NAFLD患者的CAP评分和脂肪肝分级，无论其糖尿病状态如何。
