Prevention of duodenal @entity1066 relapse with XXXX 20 mg daily: a randomized double-blind, placebo-controlled study.

@entity1 @entity1066 @entity4546
We report the first double-blind, placebo-controlled study that assesses the efficacy and safety of @entity4546 20 mg daily in the maintenance treatment of duodenal @entity1066 . For the healing phase, 128 @entity1 with endoscopically proven active duodenal @entity1066 and a history of three or more relapses during the 2 years prior to the study were treated until healing with @entity4546 40 mg daily for 2 and up to 8 weeks. One hundred and twenty-three @entity1 whose @entity1066 were healed were randomized to receive @entity4546 20 mg daily (n = 60) or placebo (n = 63) for 12 months as maintenance treatment. @entity1 were interviewed at 3, 6, 9 and 12 months, and endoscopy was performed at 3, 6 and 12 months and whenever symptoms recurred. The healing rates of the 124 @entity1 completing the healing phase were 84, 98 and 100% at 2, 4 and 8 weeks, respectively. During the maintenance phase, eight and four @entity1 discontinued treatment from the @entity4546 and placebo groups, respectively. The proportion of @entity1 in remission in the @entity4546 group and placebo group after 12 months were 94 and 9% respectively (life table estimates, P < 0.0001). No significant clinical or laboratory changes were observed in @entity1 on therapy with @entity4546 . @entity1 with a history of frequent relapses thus continued to have a very high relapse rate without prophylactic treatment. @entity4546 20 mg daily was effective and safe in maintaining such @entity1 in remission.
