Effect of multifactorial treatment on non-alcoholic fatty liver disease in metabolic syndrome: a randomised study

Authors: Athyros, Vasilios G.¹; Mikhailidis, Dimitri P.²; Didangelos, Triandafillos P.³; Giouleme, Olga I.⁴; Liberopoulos, Evangelos N.²; Karagiannis, Asterios⁵; Kakafika, Anna I.⁵; Tziomalos, Konstantinos⁵; Burroughs, Andrew K.⁶; Elisaf, Moses S.⁷

Source: Current Medical Research and Opinion, Volume 22, Number 5, May 2006 , pp. 873-883(11)

Publisher: Informa Healthcare

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Abstract:

Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome (MetS). There is no established treatment for NAFLD.

Aim: To evaluate a multifactorial intervention in the treatment of NAFLD.

Methods: A prospective, open-label, randomised study in non-diabetic patients (n = 186) with MetS (follow-up: 54 weeks). All patients had both biochemical and ultrasonographic evidence of NAFLD at baseline. Other causes of liver disease were excluded. Patients received lifestyle advice and treatment for hypertension (mainly inhibitors of the renin–angiotensin system), impaired fasting glucose (metformin), obesity (orlistat) and dyslipidaemia [randomly allocated to atorvastatin 20 mg/day (n = 63) or micronised fenofibrate 200 mg/day (n = 62) or both drugs (n = 61)]. Liver ultrasonography was assessed at baseline and at the end of the study.

Results: At the end of treatment, 67% of patients on atorvastatin, 42% on fenofibrate and 70% on combination treatment no longer had biochemical plus ultrasonographic evidence of NAFLD (p < 0.05 vs. baseline for all comparisons). The percentage of patients who no longer had evidence of NAFLD was significantly higher (p < 0.009) in the atorvastatin and combination groups compared with the fenofibrate group. This effect was independently related to drug treatment, as well as to reductions in high-sensitivity C-reactive protein, waist circumference, body weight, triglycerides, low-density lipoprotein-cholesterol, total cholesterol, systolic blood pressure and glucose. Four patients discontinued treatment because of adverse effects.

Conclusions: Multifactorial intervention in MetS patients with both biochemical and ultrasonographic evidence of NAFLD offsets surrogate markers of NAFLD (i.e. elevated aminotransferase plus echogenic liver).

Keywords: ATORVASTATIN; DYSLIPIDAEMIA; FENOFIBRATE; METABOLIC SYNDROME; NON-ALCOHOLIC FATTY LIVER DISEASE; ORLISTAT; WEIGHT LOSS

Document Type: Research article

DOI: 10.1185/030079906X104696

Affiliations: 1: Atherosclerosis and Metabolic Syndrome Units, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece; Working Group for the Identification and Treatment of Metabolic Syndrome of the Hellenic Atherosclerosis Society, Athens, Greece 2: Working Group for the Identification and Treatment of Metabolic Syndrome of the Hellenic Atherosclerosis Society, Athens, Greece; Department of Clinical Biochemistry, Royal Free Hospital, Royal Free and University College Medical School, London, 3: Working Group for the Identification and Treatment of Metabolic Syndrome of the Hellenic Atherosclerosis Society, Athens, Greece; Diabetes Centre, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece; Second Prop. Department of In 4: Second Prop. Department of Internal Medicine, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece; Division of Gastroenterology, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece 5: Working Group for the Identification and Treatment of Metabolic Syndrome of the Hellenic Atherosclerosis Society, Athens, Greece; Second Prop. Department of Internal Medicine, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece 6: Liver Transplantation and Hepatobiliary Medicine, Royal Free Hospital, Royal Free and University College Medical School, London, UK 7: Working Group for the Identification and Treatment of Metabolic Syndrome of the Hellenic Atherosclerosis Society, Athens, Greece; Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece

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