title: Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: a multicenter placebo-controlled study. The Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID)
abstract: BACKGROUND
  Mesalamine provides a new therapeutic approach in treating Crohn's disease.
  
  
  METHODS
  To assess the efficacy and safety of slow-release mesalamine (Pentasa; Ferring AS, Vanløse, Denmark) in maintaining remission in Crohn's disease, 161 patients with inactive disease were randomized to receive either Pentasa (2 g/day) or placebo in a 2-year double-blind, multicenter trial. Two strata were defined according to the duration of their remission: < 3 months (n = 64) or 3-24 months (n = 97), presumed to be high and a low relapse risk strata, respectively.
  
  
  RESULTS
  The probability of relapse was higher in the short-remission placebo group than in the three other groups (P < 0.003), showing there was a significant benefit from Pentasa in the high relapse risk stratum. In this stratum, the 2-year ongoing remission rate was of 29% +/- 9% and 45% +/- 11% (mean +/- SD) in the placebo and Pentasa groups, respectively. The incidences of side effects were similar in both groups.
  
  
  CONCLUSIONS
  Pentasa (2 g/day for 2 years) is a safe and effective maintenance treatment for Crohn's disease when given within 3 months of achieving remission.
authors.affiliation: Hôpital Rothschid, Paris, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Gendre
authors.forename: J Y
authors.initials: JY
authors.lastname: Mary
authors.forename: C
authors.initials: C
authors.lastname: Florent
authors.forename: R
authors.initials: R
authors.lastname: Modigliani
authors.forename: J F
authors.initials: JF
authors.lastname: Colombel
authors.forename: J C
authors.initials: JC
authors.lastname: Soulé
authors.forename: J P
authors.initials: JP
authors.lastname: Galmiche
authors.forename: E
authors.initials: E
authors.lastname: Lerebours
authors.forename: L
authors.initials: L
authors.lastname: Descos
authors.forename: J M
authors.initials: JM
authors.lastname: Viteau
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000636:Aminosalicylic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine; D008875:Middle Aged; D010349:Patient Compliance; D016896:Treatment Outcome
chemical_list: D000636:Aminosalicylic Acids; D003692:Delayed-Action Preparations; D019804:Mesalamine