[Safety and Efficacy of Amlodipine, Lisinopril and Rosuvastatin Therapy in Patients With Metabolic Syndrome and Nonalcoholic Fatty Liver Disease].

AIM: To evaluate the efficacy and safety of amlodipin, lisinopril and rosuvastatin therapy in metabolic syndrome and high cardiovascular risk patients with nonalcoholic fatty liver disease (NAFLD).

PATIENTS AND METHODS: 6 months randomized study of fixed combination of amlodipin and lisinopril with or without rosuvastatin of 20 patients with 2 grade of arterial hypertension, dyslipidemia with metabolic syndrome and nonalcoholic fatty liver disease (NAFLD). Efficacy and safety was revealed: office BP, ABPM, NAFLD Fibrosis scale, insulin resistance index (HOMA-IR), serum lipids were measured basically and after 6 months of therapy.

RESULTS: 6 months amlodipin and lisinopril therapy results: office BP decreased from 153,4+/-2,9/83,3+/-2,5 to 131,0+/-2,4/79,9+/-4,5 mm Hg (=0,001, for systolic BP).159/91 to 132/77 mm Hg. 24-hours BP decreased from 153,6+/-3,6/89,5+/-3,2 to 127,1+/-3,0/73,5+/-2,9 (=0,002); in 85% of patients BP normalized. Low density lipoprotein cholesterol (LDL-C) decreased lower 2.5 mmol/l in all patients and lower 1.8 mmol/l in 45% patients on rosuvastatin therapy. Before therapy 3 patients had elevated ALT levels, after 6 months therapy all patients had normal levels of ALT and AST. ALT decreased from 33,7+/-4,3 to 23,2+/-3,5 U/l (=0,01). Alkaline phosphatase decreased from 65,4+/-4,1 to 51,1+/-6,9 U/l (=0,02), gamma glutamyl transpeptidase level was stable. NAFLD Fibrosis index revealed fibrosis and was stable -0,9+/-0,2 and -0,9+/-0,2 (>0,05). HOMA-IR decreased from 4.2+/-0,4 to 2,9+/-0,4 (=0,02).

DISCUSSION: Some antihypertensive drugs and statins can be hepatotoxic especially in patients with metabolic syndrome and NAFLD. Antihypertensive drugs and statins with minimal liver metabolism can be preferable in NAFLD patients.

CONCLUSION: Amlodipin, lisinopril and rosuvastatin therapy is effective and safe in patients with metabolic syndrome of high cardiovascular risk and liver steatosis.