Efficacy and safety of ezetimibe/simvastatin combination therapy in patients with type 2 diabetes and nonalcoholic fatty liver disease

Abstract

Nonalcoholic fatty liver disease is commonly associated with type 2 diabetes, dyslipidemia and obesity all of which are components of the metabolic syndrome. To determine the efficacy and safety of ezetimibe/simvastatin 10/20mg combination therapy on patients with type 2 diabetes and nonalcoholic fatty liver disease. We studied nineteen patients with type 2 diabetes and nonalcoholic fatty liver disease diagnosed and treated between 2005 and 2008 at Health Center of Budaörs. After six months of ezetimibe/simvastatin (10/20mg/day) combination treatment, all patients were assessed for changes serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides. Six months of ezetimibe/simvastatin administration reduced significantly the serum levels of ALT (63.78+/-5.12 vs 32.57+/-3.92 U/L; p < 0.0001), AST (50.79+/-3.66 vs 23.68+/-3.42 U/L; p < 0.0001), cholesterol (6.26+/-0.46 vs 4.02+/-0.31 mmol/L; p < 0.0001) and LDL-cholesterol (4.24+/-0.37 vs 2.22+/-0,1 mmol/L; p < 0.0001). Combination therapy reduced significantly serum triglyceride level (2.62+0.48 vs 1.33+0.20 mmol/L; p < 0.0001) and increased the level of HDL-cholesterol (1.02+/-0.12 vs 1.18+/-0.07 mmol/L; p < 0.0001). These findings indicate that ezetimibe/simvastatin combination therapy is safe and effective in patients with type 2 diabetes and nonalcoholic fatty liver disease.