[Efficacy and safety of ezetimibe/simvastatin combination therapy in patients with type 2 diabetes and nonalcoholic fatty liver disease].
Nonalcoholic fatty liver disease is commonly associated with type 2 diabetes, dyslipidemia and obesity all of which are components of the metabolic syndrome.


OBJECTIVE
To determine the efficacy and safety of ezetimibe/simvastatin 10/20mg combination therapy on patients with type 2 diabetes and nonalcoholic fatty liver disease.


METHODS
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.


RESULTS
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).


CONCLUSIONS
These findings indicate that ezetimibe/simvastatin combination therapy is safe and effective in patients with type 2 diabetes and nonalcoholic fatty liver disease.
Abel
Tatjána
T
Allami Egészségügyi Központ, Szakrendelo Intézet, Budapest. drabelt@t-online.hu
Fehér
János
J
Dinya
Elek
E
Gamal Eldin
Mohamed
M
Kovács
Attila
A
D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001384:Azetidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D048909:Diabetes Complications / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005234:Fatty Liver / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019821:Simvastatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055105:Waist Circumference
D000924:Anticholesteremic Agents; D001384:Azetidines; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000069438:Ezetimibe