title: Low-dose versus high-dose ursodeoxycholic acid in cystic fibrosis-related cholestatic liver disease. Results of a randomized study with 1-year follow-up.
abstract: BACKGROUND
  Ursodeoxycholic acid (UDCA) is beneficial in cholestasis related to cystic fibrosis (CF). High-dose treatment has been recommended to compensate for bile salt malabsorption. We compared the results of low-dose (10 mg/kg/day) and high-dose (20 mg/kg/day) UDCA treatment on liver biochemistry after 3 and 12 months' treatment.
  
  
  METHODS
  Thirty CF patients (age > 5 years) with biochemical cholestasis and compensated liver disease were randomized for low-dose (n = 17) or high-dose (n = 13) UDCA. Baseline clinical variables were comparable.
  
  
  RESULTS
  After 1 year one patient had died of liver failure (low dose), and three had dropped out because of pruritus (one in each group) or personal choice (low dose). In the high-dose group improvement in gamma-glutamyl transferase values was more pronounced after 3 months and 1 year (P < 0.004), and improvement of alanine aminotransferase was better after 1 yer (P < 0.02). Improvement of alkaline phosphatase and aspartate aminotransferase was comparable. Complete normalization of liver enzymes and bilirubin occurred more often in the high-dose group.
  
  
  CONCLUSIONS
  High-dose UDCA induces a better response of liver biochemistry values than low-dose UDCA in CF patients with cholestatic liver disease.
authors.affiliation: Dept. of Gastroenterology, University Hospital, Utrecht, The Netherlands.
authors.forename: P C
authors.initials: PC
authors.lastname: van de Meeberg
authors.forename: R H
authors.initials: RH
authors.lastname: Houwen
authors.forename: M
authors.initials: M
authors.lastname: Sinaasappel
authors.forename: H G
authors.initials: HG
authors.lastname: Heijerman
authors.forename: C M
authors.initials: CM
authors.lastname: Bijleveld
authors.forename: G P
authors.initials: GP
authors.lastname: Vanberge-Henegouwen
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002756:Cholagogues and Choleretics / Q000008:administration & dosage* / Q000627:therapeutic use; D002780:Cholestasis, Intrahepatic / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*; D004796:Clinical Enzyme Tests; D003550:Cystic Fibrosis / Q000150:complications*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D013997:Time Factors; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid