THE EFFICACY AND SAFETY OF VILDAGLIPTIN TREATMENT FOR NONALCOHOLIC FATTY LIVER DISEASE IN TYPE 2 DIABETES MELLITUS

Abstract

Introduction: It is known that dipeptidyl peptidase-4 inhibitors were useful for the treatment of type 2 diabetes mellitus (DM). However, effects of these drugs on liver function and glucose metabolism in nonalcoholic fatty liver disease (NAFLD) have not been well determined. Except the improvement of glycemic control observed in type 2 DM; dipeptidyl peptidase IV (DPP-4) inhibitors have also been reported to have non-glycemic actions with decreasing receptor for advanced glycation end-products (RAGE) expression [1], vascular relaxation and increasing nitric oxide release [2] reducing lipid and protein oxidation [3] improving hepatic steatosis [4] or anti-inflammatory actions [5]. We evaluated the effect of vildagliptin on nonalcoholic fatty liver which has a widespread use in the treatment of diabetes. Aims & Methods: The aim of this study was to evaluate the effect of vildagliptin on liver functions and hepatic steatosis and also to evaluate efficacy and safety of vildagliptin in NAFLD patients with type 2 DM.Fifty-four patients with Type 2 DM, whom were newly started vildagliptin treatment and diagnosed as NAFLD by ultrasonography, were prospectively enrolled from June 2014 to June 2015 in Bozok University Hospital, Yozgat, Turkey. All patients were subjected to lifestyle intervention of diet and physical exercise after the diagnosis of T2DM. Patients aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), HbA1c, waist circumference (WC), body mass index (BMI), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and demographic characteristics were recorded before, 3 and 6 months after the initiation of treatment. Liver non-invasive assessment tools such as, Fatty Liver Index (FLI), FIB-4 score, APRI Score, were also evaluated. Vildaliptin treatment was given 100 mg per day. Results: Characteristics of patients were given in Table 1 during and pretreatment time. HbA1c was reduced from 8.48±1.43% to 7.87±1.35% (P<0.001). There were no significant difference between patients AST, GGT, ALP, HDL and FIB- 4 score before and after treatment values (P>0.05). HbA1c was reduced from 8.95% (8.07-10.35) to 7.00% (6.27-8.10) (P<0.001). During vildagliptin treatment, ALT levels improved from 30.91±26.48 to 25.94±14.8 IU/L (P=0.048). The serum levels of TG and LDL decreased with statistical significance (P<0.05). WC and BMI were also decreased (P<0.001). FLI and APRI score improved at 6 months after the initiation of vildagliptin. All the patients could take vildagliptin of 100 mg/day without reduction necessitated by related side-effects. Conclusion: Our preliminary study results showed that vildagliptin treatment have positive effect on blood sugar regulation, body composition, ALT and non-invasive liver tools for the treatment of T2DM complicated with NAFLD. Our results indicated that vildagliptin is effective and safe in NAFLD patients with Type 2 DM.