title: Impact of budesonide on liver function tests and gut inflammation in patients with primary sclerosing cholangitis and ileal pouch anal anastomosis.
abstract: OBJECTIVE
  Budesonide has been studied in patients with primary sclerosing cholangitis (PSC). This study was designed to evaluate the efficacy of oral budesonide on liver function tests in patients with PSC and pouchitis associated with ileal pouch-anal anastomosis (IPAA).
  
  
  METHODS
  The study group consisted of 18 pouch patients with underlying ulcerative colitis (UC) and PSC who were treated with 9 mg daily of budesonide for their underlying pre-pouch ileitis and pouchitis for 1-3 months followed by 3-6 mg maintenance for another 9 months. Demographic and clinical variables were analyzed.
  
  
  RESULTS
  The mean age was 39.4±12.4 years (range, 21-59 years). There was no significant change in aspartate aminotransferase (AST) [median (interquartile range) (IQR) 32 (25, 43.8) vs. 35.5 (25.5, 53), p=0.35], alanine aminotransferase (ALT) [37.5 (25.5, 49.5) vs. 40 (30, 84.3), p=0.29], alkaline phosphatase [142.5 (98.5, 264.5) vs. 126 (94.3, 189.5), p=0.35], serum bilirubin [0.7 (0.4, 1.3) vs., 0.6 (0.4, 1.6), p=0.13] or albumin levels [4.3 (3.9, 4.4) vs. 4.2 (3.8, 4.4), p=0.22] at the end of the treatment period (1 year). The revised Mayo Risk Score did not change significantly and three patients required evaluation for liver transplantation during treatment. There was a significant improvement in the endoscopy subscores in the afferent limb and pouch after a year of budesonide treatment (p=0.001).
  
  
  CONCLUSIONS
  Oral budesonide appears to have no impact on liver function tests in pouch patients with PSC. However it significantly improved afferent limb and pouch inflammation in IPAA patients.
authors.affiliation: Departments of Gastroenterology and Colorectal Surgery, Digestive Disease Institute, the Cleveland Clinic Foundation, Cleveland, OH, USA.
authors.forename: Udayakumar
authors.initials: U
authors.lastname: Navaneethan
authors.forename: Preethi G K
authors.initials: PG
authors.lastname: Venkatesh
authors.forename: Ana E
authors.initials: AE
authors.lastname: Bennett
authors.forename: Viral
authors.initials: V
authors.lastname: Patel
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hammel
authors.forename: Ravi P
authors.initials: RP
authors.lastname: Kiran
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: McCullough
authors.forename: Bo
authors.initials: B
authors.lastname: Shen
mesh_terms: D000328:Adult; D001003:Anal Canal / Q000601:surgery*; D000714:Anastomosis, Surgical; D015415:Biomarkers / Q000097:blood*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D015209:Cholangitis, Sclerosing / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003093:Colitis, Ulcerative / Q000097:blood / Q000150:complications / Q000601:surgery; D039021:Colonic Pouches; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D019449:Pouchitis / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D016737:Proctocolectomy, Restorative; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D005938:Glucocorticoids; D019819:Budesonide