Mohamed Asmaa S, Ahmad Hosam M, Sharawy Mohammed A, Kamel Fatma M M
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Port said University, Port said, Egypt.
Internal Medicine and Biomedical Chemistry Departments, Egypt Ministry of Health and Population, Minia, Egypt.
BMC Pharmacol Toxicol. 2024 Dec 13;25(1):94. doi: 10.1186/s40360-024-00818-7.
The risk of hepatic steatosis (HS) is elevated in patients with type 2 diabetes mellitus (T2D). Antidiabetic medications may contribute to the prevention or treatment of HS. This study aimed to compare the effects of vildagliptin and metformin on hepatic steatosis in newly diagnosed T2D patients, using the Hepatic Steatosis Index (HSI) and ultrasound grading.
The study included 246 newly diagnosed T2D patients who were randomly assigned to two groups. The first group (117 patients) received 50 mg of vildagliptin orally twice daily. The second group (129 patients) received 500 mg of metformin orally twice daily with meals, and the dosage could be gradually increased by 500 mg per week, up to a maximum daily dose of 2000 mg. Baseline and 6-month follow-up assessments included fasting blood glucose (FBG), HbA1c, weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), the Hepatic Steatosis Index (HSI), and hepatic steatosis grading via ultrasound.
Both groups showed significant improvements in FBG, HbA1c, weight, BMI, WC, HC, HSI, and ultrasound grading of hepatic steatosis from baseline to the 6-month follow-up (p < 0.001). The metformin group demonstrated significantly greater reductions in weight and BMI compared to the vildagliptin group (p = 0.001 and p = 0.009, respectively). However, there was no significant difference between the two groups in terms of hepatic steatosis improvement on ultrasound. Correlation analysis revealed that HSI was significantly associated with HbA1c, BMI, WC, and HC (p < 0.001 for all), as well as FBG (p = 0.008), but not with age. The lipid profile, particularly total cholesterol and LDL, was identified as a stronger predictor of hepatic steatosis, based on high AUC, sensitivity, and specificity values.
Both vildagliptin and metformin are effective in improving glycemic control in newly diagnosed T2D patients, as evidenced by reductions in FBG and HbA1c levels. Additionally, both drugs significantly reduced the HSI, body weight, and BMI, with metformin showing a more pronounced effect on weight and BMI. Both vildagliptin and metformin effectively decreased hepatic steatosis in T2D patients. Total cholesterol and LDL are important predictors of hepatic steatosis.
Trial Registration ID: UMIN000055121, registered on 30/07/2024 (retrospectively registered).
2型糖尿病（T2D）患者发生肝脂肪变性（HS）的风险升高。抗糖尿病药物可能有助于预防或治疗HS。本研究旨在使用肝脂肪变性指数（HSI）和超声分级比较维格列汀和二甲双胍对新诊断T2D患者肝脂肪变性的影响。
该研究纳入了246例新诊断的T2D患者，这些患者被随机分为两组。第一组（117例患者）每天口服两次50mg维格列汀。第二组（129例患者）每天随餐口服两次500mg二甲双胍，剂量可每周逐渐增加500mg，最大日剂量为2000mg。基线和6个月随访评估包括空腹血糖（FBG）、糖化血红蛋白（HbA1c）、体重、体重指数（BMI）、腰围（WC）、臀围（HC）、肝脂肪变性指数（HSI）以及通过超声进行的肝脂肪变性分级。
从基线到6个月随访，两组患者的FBG、HbA1c、体重、BMI、WC、HC、HSI以及肝脂肪变性的超声分级均有显著改善（p<0.001）。与维格列汀组相比，二甲双胍组的体重和BMI下降更为显著（分别为p = 0.001和p = 0.009）。然而，两组在肝脂肪变性改善的超声检查方面无显著差异。相关性分析显示，HSI与HbA1c、BMI、WC和HC显著相关（均p<0.001），与FBG也显著相关（p = 0.008），但与年龄无关。基于高曲线下面积（AUC）、敏感性和特异性值，血脂谱，尤其是总胆固醇和低密度脂蛋白（LDL）被确定为肝脂肪变性更强的预测指标。
维格列汀和二甲双胍均能有效改善新诊断T2D患者的血糖控制，FBG和HbA1c水平降低证明了这一点。此外，两种药物均显著降低了HSI、体重和BMI，二甲双胍对体重和BMI的影响更为明显。维格列汀和二甲双胍均能有效降低T2D患者的肝脂肪变性。总胆固醇和LDL是肝脂肪变性的重要预测指标。
试验注册编号：UMIN000055121，于2024年7月30日注册（回顾性注册）。
