Efficacy and safety of dapagliflozin compared to pioglitazone in diabetic and non-diabetic patients with non-alcoholic steatohepatitis: A randomized clinical trial

IF 2.6 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Clinics and research in hepatology and gastroenterology Pub Date : 2025-01-29 DOI:10.1016/j.clinre.2025.102543

Mona S. Abdel Monem , Abdulmoneim Adel , Maggie M. Abbassi , Doaa H. Abdelaziz , Mohamed Hassany , Maissa El Raziky , Nirmeen A. Sabry

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引用次数: 0

Abstract

Background

Non-alcoholic steatohepatitis (NASH) is a serious end-stage spectrum of non-alcoholic fatty liver disease (NAFLD) with associated high risk of hepatic and extrahepatic complications. Several studies showed the significant beneficial effect of dapagliflozin on body composition, hepatic and metabolic parameters on NAFLD/NASH patients. The study aimed to investigate the efficacy and safety of dapagliflozin in both diabetic and non-diabetic biopsy-proven NASH patients; compared to pioglitazone.

Methods

This was a four-group, prospective, randomized, parallel, open label study in which 100 biopsy-proven NASH patients were selected, stratified to diabetics and non-diabetics and randomized with 1:1 allocation to either 30 mg pioglitazone or 10 mg dapagliflozin, once daily for 24 weeks. Histological evaluation, anthropometric measures, hepatic, metabolic biochemical markers, fibrosis non-invasive markers, quality of life (QOL) and medications adverse events were examined.

Results

Dapagliflozin showed a comparable histological effect to pioglitazone in both diabetic and non-diabetic patients (P>0.05). As assessed by transient elastography, it also showed a comparable effect on liver fibrosis grade improvement from baseline in diabetics (P=0.287) versus a significant superiority in non-diabetics (P=0.018). Dapagliflozin showed a significant superiority in all anthropometric measures (P<0.001) and QOL (P<0.05) among both diabetics and non-diabetics. There was a significant interaction between interventions and diabetes status on change from baseline of hepatic and metabolic panel collectively (P=0.023) in favor to dapagliflozin among diabetics.

Conclusion

Compared to pioglitazone, dapagliflozin had a comparable effect histologically, superior effect biochemically among diabetics and superior effect on liver fibrosis, steatosis and insulin resistance among non-diabetics.

Trial Registration

The study was registered on clinicaltrials.gov, identifier number NCT05254626.

查看原文本刊更多论文

达格列净与吡格列酮在糖尿病和非糖尿病非酒精性脂肪性肝炎患者中的疗效和安全性：一项随机临床试验

背景：非酒精性脂肪性肝炎（NASH）是一种严重的终末期非酒精性脂肪性肝病（NAFLD），伴有肝脏和肝外并发症的高风险。多项研究表明，达格列净对NAFLD/NASH患者的体成分、肝脏和代谢参数有显著的有益影响。该研究旨在探讨达格列净在糖尿病和非糖尿病活检证实的NASH患者中的有效性和安全性；与吡格列酮相比。方法：这是一项四组、前瞻性、随机、平行、开放标签的研究，选择100名活检证实的NASH患者，分为糖尿病患者和非糖尿病患者，按1:1的比例随机分配至30mg吡格列酮或10mg达格列净，每天一次，持续24周。检查组织学评价、人体测量、肝脏、代谢生化指标、纤维化无创指标、生活质量（QOL）和药物不良事件。结果：达格列净对糖尿病和非糖尿病患者的组织学影响与吡格列酮相当（P < 0.05）。通过瞬时弹性成像评估，它也显示了与基线相比，糖尿病患者（P=0.287）和非糖尿病患者（P=0.018）在肝纤维化等级改善方面具有相当的效果。结论：与吡格列酮相比，达格列净在糖尿病患者中具有相当的组织学作用，在生化作用上优于吡格列酮，在非糖尿病患者中对肝纤维化、脂肪变性和胰岛素抵抗的作用优于吡格列酮。试验注册：该研究在clinicaltrials.gov上注册，识别码为NCT05254626。

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来源期刊

Clinics and research in hepatology and gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

4.30

自引率

3.70%

发文量

198

审稿时长

42 days

期刊介绍： Clinics and Research in Hepatology and Gastroenterology publishes high-quality original research papers in the field of hepatology and gastroenterology. The editors put the accent on rapid communication of new research and clinical developments and so called "hot topic" issues. Following a clear Editorial line, besides original articles and case reports, each issue features editorials, commentaries and reviews. The journal encourages research and discussion between all those involved in the specialty on an international level. All articles are peer reviewed by international experts, the articles in press are online and indexed in the international databases (Current Contents, Pubmed, Scopus, Science Direct). Clinics and Research in Hepatology and Gastroenterology is a subscription journal (with optional open access), which allows you to publish your research without any cost to you (unless you proactively chose the open access option). Your article will be available to all researchers around the globe whose institution has a subscription to the journal.