Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial

作者：Jiayang Lin, Yan Huang, Bingyan Xu, Xuejiang Gu, Junlin Huang, Jia Sun, Lijing Jia, He Jiang, Chensihan Huang, Xueyun Wei, Jinjun Chen, Xiaomin Chen, Jingping Zhou, Lixian Wu, Peizhen Zhang, Yaxin Zhu, Huimin Xia, Ge Wen, Yating Liu, Shiqun Liu, Yanmei Zeng, Lin Zhou, Hongxia Jia, Hua He, Yaoming Xue, Fenglin Wu, Huijie Zhang · 发表于：BMJ · 年份：2025 · DOI：10.1136/bmj-2024-083735 · 被引用次数：102 · 研究领域：Liver Disease Diagnosis and Treatment、Diabetes Treatment and Management、Pancreatitis Pathology and Treatment

OBJECTIVE: To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in participants with metabolic dysfunction-associated steatohepatitis (MASH). DESIGN: Multicentre, double blind, randomised, placebo controlled trial. SETTING: Six tertiary hospitals in China from 23 November 2018 to 28 March 2023. PARTICIPANTS: 154 adults with biopsy diagnosed MASH, with or without type 2 diabetes. INTERVENTIONS: All participants were randomly assigned to receive 10 mg orally of dapagliflozin or matching placebo once daily for 48 weeks. MAIN OUTCOME MEASURES: The primary endpoint was MASH improvement (defined as a decrease of at least 2 points in non-alcoholic fatty liver disease activity score (NAS) or a NAS of ≤3 points) without worsening of liver fibrosis (defined as without increase of fibrosis stage) at 48 weeks. The secondary endpoints included the MASH resolution without worsening of fibrosis and fibrosis improvement without worsening of MASH. Analyses used the intention-to-treat dataset. RESULTS: MASH improvement without worsening of fibrosis was reported in 53% (41/78) of participants in the dapagliflozin group and 30% (23/76) in the placebo group (risk ratio 1.73 (95% confidence interval (CI) 1.16 to 2.58); P=0.006). Mean difference of NAS was -1.39 (95% CI -1.99 to -0.79); P<0.001). MASH resolution without worsening of fibrosis occurred in 23% (18/78) of participants in the dapagliflozin group and 8% (6/76) in the placebo group (risk ratio 2....