Abstract. D-002, a mixture of higher aliphatic beeswax alcohols, has been shown to display antiinflammatory effects associated with the dual inhibition of ciclooxygenase and 5-lipoxygenase. Oral D-002 supplementation has been effective in experimental osteoarthritis, ameliorating all features of joint histopathology. Clinical studies have demonstrated that D-002 reduces osteoarthritis symptoms. However, D-002 effects on experimental models of rheumatoid arthritis (RA) have not been evaluated. To investigate whether D-002 improves histopathological and functional outcomes in a rat model of antigen-induced arthritis. First experiment. Rats were randomized into a negative vehicle-control (sham) and four groups injected with complete Freund's adjuvant (CFA): a positive vehicle-control, three treated with D-002 (50, 200 and 400 mg/kg/day) for 21 days. Second experiment. Rats were randomized into a sham and four CFA-injected groups: a positive vehiclecontrol, two treated with D-002 (25 and 100 mg/kg/day), one with methorexate (MTX) (0.3 mg/kg) for 28 days. Arthritis severity was evaluated by bodyweight loss, decreased exploratory activity and histological changes of tarsal joint and spleen samples in both experiments, except the exploratory activity, assessed only in the first one. CFA injection decreased the bodyweight and the exploratory activity, and induced infiltration of mononuclear cells, pannus formation and vascularity in the tarsal joint of positive control rats. These changes were significantly and markedly ameliorated by D-002 as compared to the positive control. MTX also reversed CFA-induced changes. The reduction of the infiltration of mononuclear cell with D-002 400 mg/kg was greater (80.9%) than with MTX (66.8%), but effects on other variables were similar. No abnormalities in spleen samples of D-002-treated groups were detected. This is the first report demonstrating the efficacy of oral treatment with D-002 in a rat model of antigen-induced arthritis. Results suggest that D-002 could help manage RA, but confirmation of such potential benefit requires extensive further research.

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.

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