Background and Aims: Nonalcoholic fatty liver disease (NAFLD) is a common condition in Metabolic Syndrome (MS). No effective medical therapy is available for all patients with NASH. Ursodeoxycholic acid (UDCA) has been suggested to be of benefit based on open label clinical studies. Many patients with NAFLD and MS have hyperlipidemia, their elevated serum aminotransferase levels make physicians wary about prescribing statins. However, the benefits NAFLD and MS patients from statin therapy would most likely outweigh any theoretical risk of liver injury. Combination of Ursodeoxycholic acid (UDCA) and Simvastatin is perspective for the treatment dyslipidemia and NAFLD. The aim was to assess the efficacy of UDCA and Simvastatin in MS patients with NAFLD and dyslipidemia. Methods: We examined 80 MS patients, 46 men (average age 48±13 years; BMI = 33.4±4.9 kg/m2; waist circumference = 113.2±11.1 cm) and 34 women (average age 45±10 years; BMI = 33.2±3.9 kg/m2; waist circumference = 93.4±9.2 cm ) with clinic, laboratory, ultrasound proven NAFLD and laboratory proven dyslipidemia. Liver biopsy was performed in 68 patients with elevated liver function tests and showed histological findings proven non-alcoholic steatohepatitis (NASH). All patients received UDCA in doses of 600 mg/day and simvastatin 40 mg/day over a period of 6 months. Results: In the NASH group the mean serum AST levels decreased from 82.2±26.4 to 38.±11.2 IU/L, serum ALT levels from 95.9±24.4 to 31.9±16.3 IU/L at the end of the treatment period (p < 0.0003). After 4 weeks we had no one case of increasing AST or ALT levels on the UDCA and simvastatin therapy. 95,5 % patients (n =65/68) with NASH reached normal liver function tests. All 80 patients decreased total cholesterol levels from 248±38.6 to 171±23.3 mg/dl, triglyceride from 263.7±121.6 to 162±49 mg/dl, LDL from 150.9±49.7 to 92.8±24 mg/dl, increased HDL from 40±14 to 48.2±10 mg/dl at the end of the study (p < 0.000006). Conclusions: A significant improvement in the levels of aminotransferases and lipids levels was obtained with combination of UDCA and Simvastatin in NAFLD patients. These results reveal that UDCA and Simvastatin may be considered an effective treatment in patients with NASH and MS. Thus, lipid-lowering agents and UDCA should be prescribed for patients with NAFLD unless contraindicated, with careful monitoring of transaminase levels during therapy.
URSODEOXYCHOLIC ACID AND SIMVASTATIN IN PATIENTS WITH NONALCOHOLIC FATTY LIVER DISEASE AND METABOLIC SYNDROME
BERTINO, Gaetano;BRUNO, Cosimo Marcello;FISICHELLA, Alfredo;CAMPAGNA D;NERI, Sergio
2010-01-01
Abstract
Background and Aims: Nonalcoholic fatty liver disease (NAFLD) is a common condition in Metabolic Syndrome (MS). No effective medical therapy is available for all patients with NASH. Ursodeoxycholic acid (UDCA) has been suggested to be of benefit based on open label clinical studies. Many patients with NAFLD and MS have hyperlipidemia, their elevated serum aminotransferase levels make physicians wary about prescribing statins. However, the benefits NAFLD and MS patients from statin therapy would most likely outweigh any theoretical risk of liver injury. Combination of Ursodeoxycholic acid (UDCA) and Simvastatin is perspective for the treatment dyslipidemia and NAFLD. The aim was to assess the efficacy of UDCA and Simvastatin in MS patients with NAFLD and dyslipidemia. Methods: We examined 80 MS patients, 46 men (average age 48±13 years; BMI = 33.4±4.9 kg/m2; waist circumference = 113.2±11.1 cm) and 34 women (average age 45±10 years; BMI = 33.2±3.9 kg/m2; waist circumference = 93.4±9.2 cm ) with clinic, laboratory, ultrasound proven NAFLD and laboratory proven dyslipidemia. Liver biopsy was performed in 68 patients with elevated liver function tests and showed histological findings proven non-alcoholic steatohepatitis (NASH). All patients received UDCA in doses of 600 mg/day and simvastatin 40 mg/day over a period of 6 months. Results: In the NASH group the mean serum AST levels decreased from 82.2±26.4 to 38.±11.2 IU/L, serum ALT levels from 95.9±24.4 to 31.9±16.3 IU/L at the end of the treatment period (p < 0.0003). After 4 weeks we had no one case of increasing AST or ALT levels on the UDCA and simvastatin therapy. 95,5 % patients (n =65/68) with NASH reached normal liver function tests. All 80 patients decreased total cholesterol levels from 248±38.6 to 171±23.3 mg/dl, triglyceride from 263.7±121.6 to 162±49 mg/dl, LDL from 150.9±49.7 to 92.8±24 mg/dl, increased HDL from 40±14 to 48.2±10 mg/dl at the end of the study (p < 0.000006). Conclusions: A significant improvement in the levels of aminotransferases and lipids levels was obtained with combination of UDCA and Simvastatin in NAFLD patients. These results reveal that UDCA and Simvastatin may be considered an effective treatment in patients with NASH and MS. Thus, lipid-lowering agents and UDCA should be prescribed for patients with NAFLD unless contraindicated, with careful monitoring of transaminase levels during therapy.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
