ABSTRACT
AIM OF THE STUDY: To investigate the efficacy and safety of Abexol and atorvastatin in patients with non-alcoholic fatty liver disease (NAFLD).Material and methods: The present study had a monocentric, randomized, double-blinded, comparative design with 4 parallel groups - group 1 (Abexol), group 2 (atorvastatin), group 3 (combined therapy) and group 4 (placebo) - to which dietary recommendations and physical activity practice were provided twice a day, for 24 weeks. Significant changes in the ultrasound analysis of the liver were considered a primary efficacy variable. Insulin resistance improvement (HOMA2-IR) was considered as a co-primary efficacy criterion. Significant changes in the serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), lipid profile variables and the anthropometric variables were evaluated as secondary variables of effectiveness. Statistical analysis of all data was according to the intention to treat method. RESULTS: The groups were statistically homogeneous at baseline conditions. At the end of the 6 months of treatment about 50% of the patients in all groups showed a decrease of at least one degree in echogenicity, while the rest remained the same. There were no significant changes in the values of liver enzymes or anthropometric variables evaluated. Treatment with atorvastatin and combined therapy significantly reduced levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol. The treatments were safe and well tolerated, although in the atorvastatin group the number of adverse events reported was greater than in the rest of the groups. CONCLUSIONS: Abexol and atorvastatin showed comparable efficacy and safety in patients with NAFLD, with advantages for treatment with atorvastatin with respect to its effects on the lipid profile of these patients.
ABSTRACT
BACKGROUND: Autoimmune liver diseases (AILD) comprise a set of entities characterized by tissue damage as a result of the loss of self-tolerance. There are few reports of AILD from Caribbean countries. OBJECTIVES: The aim of our study was to investigate the clinical patterns, laboratory findings, and immunologic features, treatment responses, and prognoses of AILD in adult patients at a Cuban tertiary referral center. METHODS: A prospective study was conducted at the National Institute of Gastroenterology in Havana, Cuba, from May 2012 to April 2016. Clinical, immunologic, and histologic features of autoimmune hepatitis (AIH), primary biliary cirrhosis, AIH/primary biliary cirrhosis overlap syndrome, autoimmune cholangiopathy, and primary sclerosing cholangitis were recorded. Response to therapy was assessed by serum alanine aminotransferase and bilirubin levels at 3, 6, 12, and 24 months after treatment initiation. RESULTS: Of the 106 patients included in the study, 85.5% were women. The median age at presentation was 47 years. AIH was the most common AILD and was diagnosed in 60 patients (56.6%), 55 of whom had type 1 AIH. Primary biliary cirrhosis was diagnosed in 22 patients (20.7%), overlap syndrome in 16 patients (15%), autoimmune cholangiopathy in 5 patients (4.71%), and PSC in 3 patients (2.8%). Most patients were symptomatic; 48 patients (45.2%) presented with liver cirrhosis, 14.5% of whom had decompensated cirrhosis. Follow-up of treatment was between 6 and 24 months. Prednisone monotherapy was used in 22 AIH patients (36.6%) and a combination of prednisone and azathioprine was used in 28 (46.6%) AIH patients. Response to treatment was seen in 41 AIH patients (68.3%), 33 of whom (55%) had a complete response and 8 of whom (24.2%) relapsed after 12 months of maintenance therapy. No or incomplete response to treatment was seen in 18 patients (30%). In 46 patients with autoimmune cholestasis, ursodeoxycholic acid was used as monotherapy in 25 patients (54.3%). CONCLUSIONS: The clinical profile of AILD in a sample of the Cuban population is similar to that reported in South areas (Developing countries). AIH was more frequent than PBC, and usually presented with advanced liver disease that responded poorly to treatment.
