title: 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.
abstract: OBJECTIVE
  Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD.
  
  
  METHODS
  This was an eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ≥6 and Endoscopic Index (EI) ≥4, received budesonide (Budenofalk® 3mg capsules×3) or mesalazine (Salofalk® 1000mg granules×3). The primary endpoint was clinical remission at week 8 (CAI ≤4 with stool frequency and rectal bleeding subscores of "0").
  
  
  RESULTS
  343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of symptoms was 14.0 days (budesonide) and 11.0 days (mesalazine) (hazard ratio 1.19; 95% CI [0.94, 1.51]). Mucosal healing was observed in 54/177 (30.5%) budesonide patients versus 65/166 (39.2%) mesalazine patients, a difference of -8.6% (95% CI [-18.7%, 1.4%]; p=0.093). The incidences of adverse events (budesonide 26.6%, mesalazine 25.3%) and serious adverse events (budesonide 1.7%, mesalazine 1.2%) were similar.
  
  
  CONCLUSIONS
  Once-daily 3g mesalazine administered as granules is superior to 9mg budesonide OD administered as capsules for achieving remission in mild-to-moderately active UC. However, it is noteworthy that remission of UC was attained in about 40% of budesonide-treated patients with a rapid onset of resolution.
authors: Medizinische Klinik II, Klinikum St. Marien, Mariahilfbergweg 5-7, 92224 Amberg, Germany. gross.volker@klinikum-amberg.de
authors: Volker
authors: V
authors: Gross
authors: Ivan
authors: I
authors: Bunganic
authors: Elena A
authors: EA
authors: Belousova
authors: Tatyana L
authors: TL
authors: Mikhailova
authors: Limas
authors: L
authors: Kupcinskas
authors: Gediminas
authors: G
authors: Kiudelis
authors: Zsolt
authors: Z
authors: Tulassay
authors: Libor
authors: L
authors: Gabalec
authors: Andrey E
authors: AE
authors: Dorofeyev
authors: Jelena
authors: J
authors: Derova
authors: Karin
authors: K
authors: Dilger
authors: Roland
authors: R
authors: Greinwald
authors: Ralph
authors: R
authors: Mueller
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D053208:Kaplan-Meier Estimate; D008297:Male; D019804:Mesalamine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction
chemical_list: D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine; D019819:Budesonide; D006854:Hydrocortisone