TY - JOUR
T1 - Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease
T2 - A multicenter placebo-controlled study
AU - Gendre, Jean Pierre
AU - Mary, Jean Yves
AU - Florent, Christian
AU - Modigliani, Robert
AU - Colombel, Jean Frédéric
AU - Soulé, Jean Claude
AU - Galmiche, Jean Paul
AU - Lerebours, Eric
AU - Descos, Louis
AU - Viteau, Jean Michel
AU - René, Emmanuel
AU - Metman, Edouard Henri
AU - Bories, Philippe
AU - Bremondy, Alain
AU - Bouvry, Michel
AU - Lamouliatte, Hervé
AU - Gineston, Jean Louis
PY - 1993/2
Y1 - 1993/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0027528294&partnerID=8YFLogxK
U2 - 10.1016/0016-5085(93)90411-5
DO - 10.1016/0016-5085(93)90411-5
M3 - Article
C2 - 8425685
AN - SCOPUS:0027528294
SN - 0016-5085
VL - 104
SP - 435
EP - 439
JO - Gastroenterology
JF - Gastroenterology
IS - 2
ER -