title: Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid.
abstract: BACKGROUND
  Newer therapies are needed for patients with primary biliary cirrhosis and incomplete response to ursodeoxycholic acid (UDCA). Fenofibrate is a fibric acid postulated to regulate immune response and cell proliferation.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of fenofibrate in patients with primary biliary cirrhosis and incomplete response to UDCA.
  
  
  METHODS
  We undertook a pilot study involving 20 patients with primary biliary cirrhosis and serum alkaline phosphatase (ALP) ≥ 2× ULN. Nonparametric statistical tests and Spearman correlation test were used as appropriate.
  
  
  RESULTS
  Twenty patients received fenofibrate (160 mg/day) in addition to UDCA for 48 weeks. Median serum ALP decreased significantly at 48 weeks compared with baseline values [351 (214-779) U/L at baseline vs. 177 (60-384) U/L at 48 weeks, P < 0.05]. A rebound in ALP occurred upon drug discontinuation. Serum aspartate aminotransferase and Immunoglobulin M also decreased significantly, while bilirubin and albumin remained unchanged. Median IL-1 decreased from 28.9 (2.7-10 000) to 11.3 (2.5-277.7) pg/mL (P = 0.049), and median IL-6 from 4.6 (3.2-5205) to 3.5 (3.2-73.4) pg/mL (P = 0.027). Heartburn was the most frequent adverse event, leading to discontinuation of two study subjects.
  
  
  CONCLUSIONS
  Combination therapy of fenofibrate and UDCA induced significant biochemical improvement in patients with primary biliary cirrhosis and incomplete response to UDCA. Further studies are warranted.
authors.affiliation: Department of Medicine, University of Florida, Gainesville, USA. clevy@med.miami.edu
authors.forename: C
authors.initials: C
authors.lastname: Levy
authors.forename: J A
authors.initials: JA
authors.lastname: Peter
authors.forename: D R
authors.initials: DR
authors.lastname: Nelson
authors.forename: J
authors.initials: J
authors.lastname: Keach
authors.forename: J
authors.initials: J
authors.lastname: Petz
authors.forename: R
authors.initials: R
authors.lastname: Cabrera
authors.forename: V
authors.initials: V
authors.lastname: Clark
authors.forename: R J
authors.initials: RJ
authors.lastname: Firpi
authors.forename: G
authors.initials: G
authors.lastname: Morelli
authors.forename: C
authors.initials: C
authors.lastname: Soldevila-Pico
authors.forename: K
authors.initials: K
authors.lastname: Lindor
mesh_terms: D000328:Adult; D000368:Aged; D002756:Cholagogues and Choleretics / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013223:Statistics as Topic; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D002756:Cholagogues and Choleretics; D000960:Hypolipidemic Agents; D014580:Ursodeoxycholic Acid; D011345:Fenofibrate