TY - JOUR
T1 - Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis
AU - BUG-1/LMC Study Group
AU - Miehlke, Stephan
AU - Aust, Daniela
AU - Mihaly, Emese
AU - Armerding, Peter
AU - Böhm, G. nther
AU - Bonderup, Ole
AU - Fernández-Bañares, Fernando
AU - Kupcinskas, Juozas
AU - Munck, Lars Kristian
AU - Rehbehn, Kai-Uwe
AU - Nacak, Tanju
AU - Greinwald, Roland
AU - Münch, Andreas
AU - Stehlk, Jiri
AU - Bonderup, Ole
AU - Munck, Lars Kristian
AU - Rannem, Terje
AU - Armerding, Peter
AU - Bläker, Michael
AU - Böhm, G. nter
AU - Hoesl, Mark
AU - Kirsch, Christian
AU - Madisch, Ahmed
AU - Meier, Eberhard
AU - Miehlke, Stephan
AU - Rehbehn, Kai-Uwe
AU - Kiss, Gyula G.
AU - Nagy, Ferenc
AU - Tulassay, Zsolt
AU - Zsigmond, Ferenc
AU - Kupcinskas, Limas
AU - Bouma, Gerd
AU - Pierik, Marieke
AU - Fernández-Bañares, Fernando
AU - Lucendo, Alfredo J.
AU - Bohr, Johan
AU - Hellström, Per
AU - Lebrun, Barbro
AU - Lindberg, Greger
AU - Münch, Andreas
AU - Vigren, Lina
AU - Wielondek, Miroslav
AU - Krauss, Martin
AU - Dignass, Axel
AU - Kruis, Wolfgang
PY - 2018
Y1 - 2018
N2 - Background & Aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter 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 in 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 multicenter 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. ClinicalTrials.gov no: NCT01209208.
AB - Background & Aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter 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 in 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 multicenter 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. ClinicalTrials.gov no: NCT01209208.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85057561240&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30195447
U2 - https://doi.org/10.1053/j.gastro.2018.08.042
DO - https://doi.org/10.1053/j.gastro.2018.08.042
M3 - Article
C2 - 30195447
SN - 0016-5085
VL - 155
SP - 1795-1804.e3
JO - Gastroenterology
JF - Gastroenterology
IS - 6
ER -