title: Long-Term Fenofibrate Treatment in Primary Biliary Cholangitis Improves Biochemistry but Not the UK-PBC Risk Score.
abstract: Fenofibrate (FF) has been suggested as a second-line agent in primary biliary cholangitis (PBC) patients who do not achieve adequate biochemical response to ursodeoxycholic acid (UDCA) monotherapy. Limited data exist on FF use beyond 12 months, and its long-term effects are unclear.
  
  
  
  To study the biochemical outcome of long-term (>12 months) FF treatment in combination with UDCA (FF + UDCA) in PBC patients and to determine the effect on predicted prognosis using the UK-PBC Risk Score.
  
  
  
  This was a retrospective cohort study of all PBC patients treated in a specialist center with FF + UDCA therapy after failure to achieve biochemical response. Liver and renal biochemical indices and the UK-PBC Risk Score at baseline and at 12, 24, 36, 48, and 60 months of FF + UDCA treatment were compared. Biochemical response was assessed using the POISE trial criteria at the end of FF + UDCA treatment.
  
  
  
  Data from 23 patients treated with FF + UDCA combination were analyzed. The median dose of fenofibrate was 200 mg/day, and median treatment duration was 21 months (range 1-123 months). Six (26 %) patients discontinued FF within 1 year. In patients who completed 12 months (n = 17) and long-term therapy, significant decrease in ALP was seen at 12 (p = 0.0002), 24 (p = 0.002), and 36 (p = 0.03) months. More than 75 % patients met the POISE criteria of ALP response at all study time points. There was no significant improvement in the 5-, 10-, and 15-year UK-PBC Risk Scores after FF + UDCA treatment. No significant renal impairment or adverse events were reported.
  
  
  
  The long-term treatment of PBC patients with fenofibrate as an adjunct to UDCA is safe and effective in improving ALP, but the treatment did not significantly reduce the estimated probability of liver-related death or need for liver transplantation.
authors.affiliation: NIHR Newcastle Biomedical Research Centre, Framlington Place, Newcastle University, Newcastle upon Tyne, UK. Vinod.hegade@ncl.ac.uk.|Department of Hepatology, Freeman Hospital, The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK. Vinod.hegade@ncl.ac.uk.|Institute of Cellular Medicine, Faculty of Medical Sciences, William Leech Building, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. Vinod.hegade@ncl.ac.uk.
authors.forename: Vinod S
authors.initials: VS
authors.lastname: Hegade
authors.affiliation: Department of Hepatology, Freeman Hospital, The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.|Institute of Cellular Medicine, Faculty of Medical Sciences, William Leech Building, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
authors.forename: Amardeep
authors.initials: A
authors.lastname: Khanna
authors.affiliation: Institute of Cellular Medicine, Faculty of Medical Sciences, William Leech Building, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
authors.forename: Lucy J
authors.initials: LJ
authors.lastname: Walker
authors.affiliation: Department of Hepatology, Freeman Hospital, The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.|Institute of Cellular Medicine, Faculty of Medical Sciences, William Leech Building, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
authors.forename: Lin-Lee
authors.initials: LL
authors.lastname: Wong
authors.affiliation: NIHR Newcastle Biomedical Research Centre, Framlington Place, Newcastle University, Newcastle upon Tyne, UK.|Department of Hepatology, Freeman Hospital, The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Jessica K
authors.initials: JK
authors.lastname: Dyson
authors.affiliation: NIHR Newcastle Biomedical Research Centre, Framlington Place, Newcastle University, Newcastle upon Tyne, UK.|Department of Hepatology, Freeman Hospital, The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.|Institute of Cellular Medicine, Faculty of Medical Sciences, William Leech Building, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
authors.forename: David E J
authors.initials: DEJ
authors.lastname: Jones
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008105:Liver Cirrhosis, Biliary / Q000097:blood / Q000188:drug therapy*; D008137:Longitudinal Studies; D008875:Middle Aged; D011379:Prognosis; D012189:Retrospective Studies; D012709:Serum Albumin; D013997:Time Factors; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D002756:Cholagogues and Choleretics; D000960:Hypolipidemic Agents; D012709:Serum Albumin; D014580:Ursodeoxycholic Acid; D003404:Creatinine; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin; D011345:Fenofibrate
keywords: Fenofibrate; PBC; Prognosis; UDCA; UK-PBC Risk Score