title: 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.
abstract: BACKGROUND
  Non-alcoholic fatty liver disease is a common health problem associated with increased liver and vascular specific complications.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt, sahar2612@yahoo.com.
authors.forename: Sahar Mohamed
authors.initials: SM
authors.lastname: El-Haggar
authors.forename: Tarek Mohamed
authors.initials: TM
authors.lastname: Mostafa
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D004359:Drug Therapy, Combination; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006820:Hyaluronic Acid / Q000097:blood; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008099:Liver / Q000187:drug effects* / Q000473:pathology; D008111:Liver Function Tests; D008297:Male; D065626:Non-alcoholic Fatty Liver Disease / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D010431:Pentoxifylline / Q000008:administration & dosage / Q000627:therapeutic use*; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D053773:Transforming Growth Factor beta1 / Q000097:blood; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D001786:Blood Glucose; D000960:Hypolipidemic Agents; D007328:Insulin; D008055:Lipids; D010726:Phosphodiesterase Inhibitors; D053773:Transforming Growth Factor beta1; D014409:Tumor Necrosis Factor-alpha; D006820:Hyaluronic Acid; D010431:Pentoxifylline; D011345:Fenofibrate