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.


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.
Abel
Tatjána
T
Outpatient Department, National Health Centre, Budapest, Hungary.
Fehér
János
J
Dinya
Elek
E
Eldin
Mohamed Gamal
MG
Kovács
Attila
A
D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D001219:Aspartate Aminotransferases / Q000097:blood; D001384:Azetidines / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D002784:Cholesterol / Q000097:blood; D003402:Creatine Kinase / Q000097:blood; D004338:Drug Combinations; D000069438:Ezetimibe; D000069499:Ezetimibe, Simvastatin Drug Combination; D005234:Fatty Liver / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000201:enzymology; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy; D008055:Lipids / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D019821:Simvastatin / Q000008:administration & dosage*; D014280:Triglycerides / Q000097:blood
D000924:Anticholesteremic Agents; D001384:Azetidines; D004338:Drug Combinations; D000069499:Ezetimibe, Simvastatin Drug Combination; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D014280:Triglycerides; D002784:Cholesterol; D019821:Simvastatin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D003402:Creatine Kinase; D000069438:Ezetimibe