title: Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis.
abstract: BACKGROUND
  Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis.
  
  
  OBJECTIVE
  To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema.
  
  
  METHODS
  Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index > 4 and endoscopic index > or = 4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index < or = 4) at the final/withdrawal visit (per protocol).
  
  
  RESULTS
  A total of 541 patients were randomized--533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%).
  
  
  CONCLUSIONS
  Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.
authors.affiliation: Hospital St. Marien, Amberg, Germany. gross.volker@klinikum-amberg.de
authors.forename: V
authors.initials: V
authors.lastname: Gross
authors.forename: S
authors.initials: S
authors.lastname: Bar-Meir
authors.forename: A
authors.initials: A
authors.lastname: Lavy
authors.forename: O
authors.initials: O
authors.lastname: Mickisch
authors.forename: Z
authors.initials: Z
authors.lastname: Tulassay
authors.forename: L
authors.initials: L
authors.lastname: Pronai
authors.forename: L
authors.initials: L
authors.lastname: Kupcinskas
authors.forename: G
authors.initials: G
authors.lastname: Kiudelis
authors.forename: J
authors.initials: J
authors.lastname: Pokrotnieks
authors.forename: A
authors.initials: A
authors.lastname: Kovács
authors.forename: M
authors.initials: M
authors.lastname: Faszczyk
authors.forename: A
authors.initials: A
authors.lastname: Razbadauskas
authors.forename: B
authors.initials: B
authors.lastname: Margus
authors.forename: M
authors.initials: M
authors.lastname: Stolte
authors.forename: R
authors.initials: R
authors.lastname: Müller
authors.forename: R
authors.initials: R
authors.lastname: Greinwald
mesh_terms: D000285:Administration, Rectal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy; D004311:Double-Blind Method; D004733:Enema / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011349:Proctitis / Q000188:drug therapy*; D011350:Proctocolitis / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide