Effect of Vildagliptin versus Vildagliptin plus Metformin on Nonalcoholic Fatty Liver Disease Patients with Type 2 Diabetes Mellitus

Abstract

Background/Aims: Nonalcoholic fatty liver disease (NAFLD) is believed to be the most common chronic liver disease. The present study aimed to evaluate the efficacy of the vildagliptin versus vildagliptin / metformin combination in the treatment of nonalcoholic fatty liver disease patients with type 2 diabetes mellitus (T 2DM). Methods: One hundred twenty patients, who were newly diagnosed with T 2DM, and proof of diagnosis of NAFLD, were enrolled in a twelve-month open label prospective parallel study. The patients were divided into two groups; Group 1 received vildagliptin in a dose of 50 mg twice daily and Group 2 received vildagliptin/metformin in a dose of 50 mg/ 1000 mg twice daily. Body mass index and fatty liver ultrasound grading were evaluated with the assay of HbA1c and serum levels of fasting and postprandial glucose, lipid profile, liver enzymes, fasting insulin, adiponectin, ferritin, and creatinine and blood urea with calculation of HOMA-IR before and after treatment. Results: There was a significant improvement in fatty liver ultrasound grading in both groups (p=0.001). Univariate and multivariate analysis showed that the improvement in NAFLD grading in both groups was affected by change in BMI, HbA1c, fasting insulin, HOMA-IR, triglycerides and adiponectin. After twelve months both groups showed significant decrease in BMI (p=0.001), fasting serum insulin (p<0.05 and p=0.001, respectively), HOMA-IR, HbA1c and triglycerides (p=0.001). However, adiponectin level increased significantly in both groups (p=0.001). Conclusion: Both vildagliptin or vildagliptin/metformin combination can improve fatty liver disease through their effect on BMI, serum levels of insulin, triglycerides, adiponectin and HOMA-IR.