Medical School, Hangzhou Normal University, Zhejiang, China.
School of Public Health, Hangzhou Normal University, Zhejiang, China.
Clin Res Hepatol Gastroenterol. 2022 Apr;46(4):101876. doi: 10.1016/j.clinre.2022.101876. Epub 2022 Mar 20.
Dapagliflozin as a treatment option in patients with nonalcoholic fatty liver disease (NAFLD) has received increasing attention, however, the efficacy and safety of dapagliflozin for NAFLD has not been well assessed. This meta-analysis aimed to summarize these RCTs and evaluate the efficacy of dapagliflozin for patients with NAFLD.
The PubMed, Embase, Web of Science, and Cochrane Library databases were searched for RCTs comparing dapagliflozin with placebo or active comparator in patients with NAFLD from inception to Oct 2021.
We included seven trials with 390 randomized participants in total. Compared to the placebo or control group, dapagliflozin could reduce the levels of alanine aminotransferase(ALT) (WMD: -6.62U/L; 95%CI: -12.66,-0.58; p = 0.03) and aspartate aminotransaminase(AST) (WMD: -4.20U/L; 95%CI: -7.92,-0.47; p = 0.03). However, dapagliflozin produced a non-significant decrease in gamma-glutamyl transferase (GGT) levels (WMD: -7.28U/L; 95%CI: -16.26,1.71; p = 0.11). Additionally, we showed that dapagliflozin significantly affect Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (WMD: -0.88; 95%CI: -1.43,-0.33; p = 0.002). Metabolic outcomes, such as bodyweight (WMD: -3.79 Kg; 95%CI: -4.63,-2.95; p < 0.00001), body mass index (BMI) (WMD: -1.33 Kg/m; 95%CI: -2.37,-0.28; p = 0.01), low-density lipoprotein cholesterol (LDL-C) (WMD: -2.66 mg/dL; 95%CI: -3.99,-1.32; p < 0.00001) and triglycerides (TG) (WMD: -16.77 mg/dL; 95%CI: -31.93,-1.61; p = 0.03) were also reduced. Meanwhile, we found that dapagliflozin increased total cholesterol (TC) (WMD: 9.77 mg/dL; 95%CI: 1.58,17.97; p = 0.02). There was no significant difference in the incidence of total adverse events between the dapagliflozin group and the control group (RR = 0.96; 95%CI: 0.60,1.54; p = 0.86).
Our results suggest that dapagliflozin effectively improves liver function parameters and metabolic outcomes among patients with NAFLD. At the same time, treatment with dapagliflozin may increase total cholesterol.
达格列净作为非酒精性脂肪性肝病(NAFLD)的治疗选择受到了越来越多的关注,然而,达格列净治疗 NAFLD 的疗效和安全性尚未得到很好的评估。本荟萃分析旨在总结这些 RCT,并评估达格列净治疗 NAFLD 患者的疗效。
从建库到 2021 年 10 月,我们在 PubMed、Embase、Web of Science 和 Cochrane 图书馆数据库中检索了比较达格列净与安慰剂或活性对照药物治疗 NAFLD 患者的 RCT。
我们共纳入了 7 项试验,共 390 名随机参与者。与安慰剂或对照组相比,达格列净可降低丙氨酸氨基转移酶(ALT)水平(WMD:-6.62U/L;95%CI:-12.66,-0.58;p=0.03)和天冬氨酸氨基转移酶(AST)水平(WMD:-4.20U/L;95%CI:-7.92,-0.47;p=0.03)。然而,达格列净对γ-谷氨酰转移酶(GGT)水平的降低作用没有统计学意义(WMD:-7.28U/L;95%CI:-16.26,1.71;p=0.11)。此外,我们发现达格列净显著影响稳态模型评估的胰岛素抵抗(HOMA-IR)(WMD:-0.88;95%CI:-1.43,-0.33;p=0.002)。代谢结局方面,达格列净可降低体重(WMD:-3.79 Kg;95%CI:-4.63,-2.95;p<0.00001)、体重指数(BMI)(WMD:-1.33 Kg/m;95%CI:-2.37,-0.28;p=0.01)、低密度脂蛋白胆固醇(LDL-C)(WMD:-2.66 mg/dL;95%CI:-3.99,-1.32;p<0.00001)和甘油三酯(TG)(WMD:-16.77 mg/dL;95%CI:-31.93,-1.61;p=0.03)。同时,我们发现达格列净可升高总胆固醇(TC)水平(WMD:9.77 mg/dL;95%CI:1.58,17.97;p=0.02)。达格列净组与对照组之间总不良事件的发生率无显著差异(RR=0.96;95%CI:0.60,1.54;p=0.86)。
我们的结果表明,达格列净可有效改善 NAFLD 患者的肝功能参数和代谢结局。同时,达格列净治疗可能会增加总胆固醇。