[Maintenance treatment of Crohn's disease using orally administered mesalazine (Pentasa). A controlled multicenter study. The Study Groups on the Treatment of Inflammatory Digestive Disorders].
BACKGROUND
Mesalamine provides a new therapeutic approach in treating Crohn's disease.


METHODS
To assess the efficacy and safety of slow-release mesalamine (Pentasa) 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 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 on-going 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.
Gendre
J P
JP
Hôpital Rothschild, Paris.
Mary
J Y
JY
Florent
C
C
Modigliani
R
R
Colombel
J F
JF
Soulé
J C
JC
Galmiche
J P
JP
Lerebours
E
E
Descos
L
L
Viteau
J M
JM
D000284:Administration, Oral; D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine; D010349:Patient Compliance; D010919:Placebos; D012307:Risk Factors
D000636:Aminosalicylic Acids; D010919:Placebos; D019804:Mesalamine
Traitement d'entretien de la maladie de Crohn par la mésalazine par voie orale (Pentasa). Etude contrôlée multicentrique. Groupe d'Etudes thérapeutiques des affections inflammatoires digestives (GETAID).