Esmaeili Ayda, Pourahmad Azar Reza, Mohammad Hosseiniazar Mohammadreza, Hooshmand Gharabagh Laya
Department of Clinical Pharmacy, School of Pharmacy Urmia University of Medical Sciences Urmia Iran.
Experimental and Applied Pharmaceutical Sciences Research Center Urmia University of Medical Sciences Urmia Iran.
J Gen Fam Med. 2024 Sep 8;25(6):351-357. doi: 10.1002/jgf2.723. eCollection 2024 Nov.
The prevalence of non-alcoholic fatty liver disease (NAFLD), which is characterized by hepatic steatosis, inflammation, and advanced fibrosis, is high among type-2 diabetes mellitus (T2DM) patients. Empagliflozin (EMPA), a sodium-glucose cotransporter-2 inhibitor, has been well established to improve glycemic status in T2DM. However, evidence of the desirable effects of EMPA, when added to the standard treatment in diabetics with coexisting NAFLD, has yet to be determined.
The main objective of the current study is to explore the benefits of EMPA on hepatic fat content in patients with T2DM and NAFLD, who received metformin (MET) monotherapy.
In this open-label clinical trial study, 60 patients with T2DM and NAFLD were assigned to either the MET + EMPA or MET group in an up-titrated manner for 24 weeks. Anthropometric characteristics, blood glucose indices, lipid profile, liver enzymes, and steatosis grades were measured at baseline and 24 weeks after the intervention.
The results showed that in patients with a mean age of 53.26 ± 7.64 who received MET+ EMPA, all the parameters had a greater decrease than the MET group. In addition, the reduction of FBS, BS, HbA1C, TG, and ALT had a statistically significant difference between the two groups after 24 weeks follow-up ( < 0.05). Notably, in the MET+ EMPA group, there was a substantial improvement in steatosis grades based on the fibroscan and ultrasound modality results.
The EMPA add-on therapeutic schedule in uncontrolled T2DM patients with NAFLD significantly ameliorated steatosis stages, liver function, anthropometric features, and biochemical parameters.
非酒精性脂肪性肝病（NAFLD）以肝脂肪变性、炎症和进展性纤维化为特征，在2型糖尿病（T2DM）患者中患病率很高。恩格列净（EMPA）是一种钠-葡萄糖协同转运蛋白2抑制剂，已被充分证实可改善T2DM患者的血糖状况。然而，在合并NAFLD的糖尿病患者中，将EMPA添加到标准治疗中的理想效果的证据尚未确定。
本研究的主要目的是探讨恩格列净对接受二甲双胍（MET）单药治疗的T2DM和NAFLD患者肝脏脂肪含量的益处。
在这项开放标签的临床试验研究中，60例T2DM和NAFLD患者以滴定方式被分配到MET+EMPA组或MET组，为期24周。在基线和干预后24周测量人体测量学特征、血糖指标、血脂谱、肝酶和脂肪变性分级。
结果显示，在平均年龄为53.26±7.64岁的接受MET+EMPA治疗的患者中，所有参数下降幅度均大于MET组。此外，随访24周后，两组间空腹血糖（FBS）、血糖（BS）、糖化血红蛋白（HbA1C）、甘油三酯（TG）和谷丙转氨酶（ALT）的降低有统计学显著差异（P<0.05）。值得注意的是，在MET+EMPA组中，基于FibroScan和超声检查结果，脂肪变性分级有显著改善。
在未控制T2DM合并NAFLD患者中，添加恩格列净的治疗方案显著改善了脂肪变性阶段、肝功能、人体测量学特征和生化参数。
