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01 December 2009

Safety and efficacy of combined ezetimibe/simvastatin treatment and simvastatin monotherapy in patients with non-alcoholic fatty liver disease

Tatjana Abel, Janos Feher, Elek Dinya, Mohamed Gamal Eldin, Attila Kovacs

Med Sci Monit 2009; 15(12): MS6-11 :: ID: 878259

Abstract

Background
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases all over the world. In patients with a high cardiovascular risk the decrease of cholesterol level is especially important. The primary goal of this study is to observe the safety and efficacy of combined ezetimibe / simvastatin treatment and simvastatin monotherapy in patients with NAFLD and high cardiovascular risk disease. The secondary goal of this investigation was to compare the safety and efficacy of combined ezetimibe / simvastatin treatment with simvastatin monotherapy.
Material and Method
The data of 45 patients with NAFLD associated with type2 diabetes and metabolic syndrome were examined. They were diagnosed and treated in Budaörs Health Centre between 2005 and 2008. Twenty-six of the patients were treated with simvastatin (20 mg/day) and 19 individuals were given ezetimibe / simvastatin therapy (10/10 mg). The safety (aspartate-aminotransferase-AST-, alanine-aminotransferase-ALT- and creatine kinase-CK-values) and efficacy (cholesterol, low density lipoprotein-LDL- cholesterol, high density lipoprotein-HDL- cholesterol and triglyceride) of the treatments had been studied for six months of the treatment period.
Results
Ezetimibe/simvastatin treatment resulted in a significant decrease in ALT (63.78+/-5.12 vs 32.57+/-3.92 U/L; p<0.0001) and AST (50.79+/-3.66 vs 23.68+/-3.42 U/L; p<0.0001). Simvastatin monotherapy also yielded significant decrease in ALT (66.58+/-6.13 vs 29.46+/-4.07 U/L; p<0.0001) and AST (59.61+/-5.97 vs 24.00+/-3.87 U/L; p<0.0001). Comparing the two treatment groups, simvastatin monotherapy reduced ALT (37.11+/-8.01 vs 31.21+/-7.08 U/L; p<0.0112) and AST (35.61+/-7.20 vs 27.10+/-5.22 U/L; p Conclusions
These results showed that both the combined ezetimibe/simvastatin treatment and the simvastatin monotherapy proved to be effective and safe in patients with NAFLD and in cases of high cardiovascular risk.

Keywords: Metabolic Syndrome X - complications, Lipids - blood, Hypercholesterolemia - drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage, Fatty Liver - enzymology, Drug Combinations, Cholesterol - blood, Creatine Kinase - blood, Cardiovascular Diseases - prevention & control, Azetidines - administration & dosage, Aspartate Aminotransferases - blood, Anticholesteremic Agents - administration & dosage, Alanine Transaminase - blood, Risk Factors, Simvastatin - administration & dosage, Triglycerides - blood

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750