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ISSN: 2392-1099
Clinical and Experimental Hepatology
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1/2021
vol. 7
 
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abstract:
Original paper

Comparative study of the effects of Abexol and atorvastatin in patients with non-alcoholic fatty liver disease

Caridad Ruenes Domech
1
,
Julio Cesar Fernandez Travieso
2
,
Zaily Dorta Guridi
1
,
Marlen Ivón Castellanos Fernández
1
,
Sacha Lazo del Vallín
1
,
Anaisa Rojas Carralero
1
,
Elena Ferrer Batallie
1
,
Aimeé Marcia Alvarez Alvarez
3
,
Lilia Fernández Dorta
2
,
José Illnait Ferrer
2
,
Sarahi Mendoza Castaño
2
,
Maytee Robaina García
4
,
Gladys Jiménez Rivero
4
,
Yeni Veliz Alvarez
4

1.
National Institute of Gastroenterology, Cuba
2.
National Centre for Scientific Research, Cuba
3.
National Institute of Endocrinology, Cuba
4.
National Coordinator Centre for Clinical Trials, Cuba
Clin Exp HEPATOL 2021; 7, 1: 55-65
DOI: https://doi.org/10.5114/ceh.2021.104387
Online publish date: 2021/03/12
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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.

keywords:

atorvastatin, Abexol, non-alcoholic fatty deposition liver disease, liver echogenicity, HOMA index
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