Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis.Miehlke S, Aust D, Mihaly E, Armerding P, Böhm G, Bonderup O, Fernández-Bañares F, Kupcinskas J, Munck L, Rehbehn KU, Nacak T, Greinwald R, Münch A; BUG-1/LMC Study Group. Gastroenterology. 2018 Sep 6. [Epub ahead of print]

BACKGROUND & AIMS:Lymphocytic colitis is a common cause of chronic, non-bloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in Cochrane review. We performed a randomized, placebo-controlled, multi-center study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis.

METHODS:Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8.RESULTS:The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than the placebo group (intention to treat analysis, 79% vs 42%; P=.01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P=.09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P=.02) or placebo (21%; P=.008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group.CONCLUSIONS:In a randomized multi-center study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. leggi l'articolo

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