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

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/METHODS: 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<or=0.0001) to a significantly larger extent related to combined ezetimibe/simvastatin therapy, while there was no substantial difference between the two treatments concerning cholesterol decrease, triglyceride reduction and HDL cholesterol elevation levels. LDL cholesterol levels decrease (62.64+/-17.01 vs 77.72+/-15.08 mg/dl; p=0.0063) to a significantly larger extent in connection with ezetimibe/simvastatin therapy.

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.