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Benefits of the Therapy With Abexol in Patients With Non-Alcoholic Fatty Liver Disease.

ABSTRACT: Background:Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of diseases ranging from steatosis to steatohepatitis and cirrhosis. Given the increasing incidence of NAFLD and the long-term consequences of this disease, it is important to identify the risk factors and therapeutic measures. Abexol is a mixture of beeswax alcohols with antioxidant, gastro-protective and anti-inflammatory effects. The aim was to conduct a pooled analysis of clinical trials data of the effects of Abexol treatment in patients with NAFLD. Methods:The present analysis includes the data of all patients with NAFLD obtained from medium-term randomized, double-blinded, placebo controlled clinical studies with Abexol. One hundred patients with NAFLD received Abexol (100 mg/day) or placebo for 6 months. Significant changes in the ultrasound analysis of the liver were considered a primary efficacy variable. Secondary endpoints were decreased homeostasis model assessment (HOMA) index and insulin levels, and improved clinical symptoms. Statistical analysis of all data was according to the intention-to-treat method. Results:Both groups were statistically homogeneous at baseline conditions. At 6 months of treatment, the number of Abexol-treated patients exhibiting a normal liver echo pattern on ultrasonography was greater than that of the placebo patients (P < 0.05). Abexol significantly reduced (P < 0.05) insulin levels and HOMA index. The proportion of Abexol patients showing symptom improvement was higher (P < 0.01) than that of the placebo group. Treatments were safe and well tolerated. Conclusions:Treatment of Abexol during 6 months significantly ameliorates liver fat accumulation and insulin resistances, meanwhile improving clinical evolution in patients with NAFLD. The treatment was safe and well tolerated in these patients.

SUBMITTER: Fernandez-Travieso JC

PROVIDER: S-EPMC7188363 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Benefits of the Therapy With Abexol in Patients With Non-Alcoholic Fatty Liver Disease.

Fernandez-Travieso Julio Cesar JC Rodriguez-Perez Ivan I Ruenes-Domech Caridad C lIlnait-Ferrer Jose J Fernandez-Dorta Lilia L Mendoza-Castano Sarahi S

Gastroenterology research 20200422 2

<h4>Background</h4>Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of diseases ranging from steatosis to steatohepatitis and cirrhosis. Given the increasing incidence of NAFLD and the long-term consequences of this disease, it is important to identify the risk factors and therapeutic measures. Abexol is a mixture of beeswax alcohols with antioxidant, gastro-protective and anti-inflammatory effects. The aim was to conduct a pooled analysis of clinical trials data of the effects o ...[more]

PMID: 32362966

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Project description:Background & Aims: Cirrhosis and liver cancer are potential outcomes of advanced nonalcoholic fatty liver disease (NAFLD). It is not clear what factors determine whether patients will develop advanced or mild NAFLD, limiting non-invasive diagnosis and treatment before clinical sequelae emerge. We investigated whether DNA methylation profiles can distinguish patients with mild disease from those with advanced NAFLD, and how these patterns are functionally related to hepatic gene expression. Methods: We collected frozen liver biopsies and clinical data from patients with biopsy-proven NAFLD (56 in the discovery cohort and 34 in the replication cohort). Samples were divided into groups based on histologic severity of fibrosis: F0?1 (mild) and F3?4 (advanced). DNA methylation profiles were determined and coupled with gene expression data from the same biopsies; differential methylation was validated in subsets of the discovery and replication cohorts. We then analyzed interactions between the methylome and transcriptome. Results: Clinical features did not differ between patients known to have mild or advanced fibrosis based on biopsy analysis. There were 69,247 differentially methylated CpG sites (76% hypomethylated, 24% hypermethylated) in patients with advanced vs mild NAFLD (P<.05). Methylation at FGFR2, MAT1A, and CASP1 was validated by bisulfite pyrosequencing and the findings were reproduced in the replication cohort. Methylation correlated with gene transcript levels for 7% of differentially methylated CpG sites, indicating that differential methylation contributes to differences in expression. In samples with advanced NAFLD, many tissue repair genes were hypomethylated and overexpressed, whereas genes in certain metabolic pathways, including 1-carbon metabolism, were hypermethylated and under-expressed. Conclusions: Functionally relevant differences in methylation can distinguish patients with advanced vs mild NAFLD. Altered methylation of genes that regulate processes such as steatohepatitis, fibrosis, and carcinogenesis indicate the role of DNA methylation in progression of NAFLD. Three technical replicates were included for quality control along with 35 mild NAFLD (33 unique samples) and 24 advanced NAFLD (23 unique sample). One sample per technical duplication was randomly included for a total of 56 NAFLD samples used for study.

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Benefits of the Therapy With Abexol in Patients With Non-Alcoholic Fatty Liver Disease.

Publications

Benefits of the Therapy With Abexol in Patients With Non-Alcoholic Fatty Liver Disease.

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