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Comparative clinical study between the effect of fenofibrate alone and its combination with pentoxifylline on biochemical parameters and liver stiffness in patients with non-alcoholic fatty liver disease

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Abstract

Background

Non-alcoholic fatty liver disease is a common health problem associated with increased liver and vascular specific complications.

Aim

The purpose of this study was to assess and compare the effect of fenofibrate alone or in combination with pentoxifylline on the measured biochemical parameters, inflammatory pathway and liver stiffness in patients with non-alcoholic fatty liver disease.

Methods

The study design was randomized controlled trial. From July 2013 to June 2014, we recruited 90 non-alcoholic fatty liver patients from the Internal Medicine Department at Tanta University Hospital, Egypt. They were classified randomly into two groups to receive fenofibrate 300 mg daily or fenofibrate 300 mg daily plus pentoxifylline 1200 mg/day in three divided doses for 24 weeks. Fasting blood sample was obtained before and 24 weeks after treatment for biochemical analysis of liver and lipid panels, tumor necrosis factor-alpha, hyaluronic acid, transforming growth factor beta 1, fasting plasma insulin and fasting glucose. Liver stiffness measurement was carried out using fibro-scan. Data were statistically analyzed by paired and unpaired Student’s t test.

Results

The data obtained suggests that adding pentoxifylline to fenofibrate does not provide a beneficial effect on lipid panel, but has a beneficial effect on indirect biochemical markers of hepatic fibrosis, a direct marker linked to matrix deposition (hyaluronic acid), a cytokine/growth factor linked to liver fibrosis (transforming growth factor beta 1), the inflammatory pathway, insulin resistance and liver stiffness as compared to fenofibrate alone.

Conclusion

The combination pentoxifylline plus fenofibrate may represent a new therapeutic strategy for non-alcoholic fatty liver disease as it resulted in more beneficial effects on direct and indirect markers of liver fibrosis, liver stiffness, insulin resistance and inflammatory pathway implicated in NAFLD.

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Acknowledgements

The authors sincerely appreciate the doctors and the radiologists of Internal Medicine Departments at Tanta University Hospital (Tanta, Egypt), for allowing their patients to participate in this study, for their aid in participants’ selection, diagnosis, LSM and for their valuable recommendations throughout this study.

Compliance with ethical requirements and Conflict of interest

The study was approved by the national research ethics committee (Tanta University ethical committee) and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. An informed written consent was obtained from all individuals included in the study. Sahar Mohamed El-Haggar and Tarek Mohamed Mostafa declare that they have no conflicts of interest.

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  1. Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt

    Sahar Mohamed El-Haggar & Tarek Mohamed Mostafa

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  1. Sahar Mohamed El-Haggar
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  2. Tarek Mohamed Mostafa
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Correspondence to Sahar Mohamed El-Haggar.

Additional information

The limitation of our study includes the relatively small number of patients investigated and hence this work needs further extension.

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El-Haggar, S.M., Mostafa, T.M. Comparative clinical study between the effect of fenofibrate alone and its combination with pentoxifylline on biochemical parameters and liver stiffness in patients with non-alcoholic fatty liver disease. Hepatol Int 9, 471–479 (2015). https://doi.org/10.1007/s12072-015-9633-1

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