title: Mesalazine granules are superior to Eudragit-L-coated mesalazine tablets for induction of remission in distal ulcerative colitis - a pooled analysis.
abstract: BACKGROUND
  Different oral formulations of 'mesalazine (mesalamine)' may have different efficacy in distal ulcerative colitis.
  
  
  OBJECTIVE
  To evaluate the efficacy of mesalazine granules (Salofalk granules) vs. mesalazine tablets (Salofalk tablets) as induction therapy in patients with distinct extensions of ulcerative colitis.
  
  
  METHODS
  A pooled analysis of 705 patients from four prospective, randomised, double-blind phase III trials was performed. The efficacy of 8 weeks' induction with 3 g/day mesalazine granules [3 g once daily (o.d.) or 1 g three times daily (t.d.s)] vs. 3 g/day mesalazine tablets (1 g t.d.s.) was compared in terms of clinical remission (CR: CAI ≤ 4) and endoscopic remission (ER: EI ≤ 3) (both according to Rachmilewitz) in subgroups with pancolitis, left-sided colitis, or proctosigmoiditis.
  
  
  RESULTS
  Mesalazine granules were equipotent to mesalazine tablets in pancolitis regarding CR (72% vs. 71%, P = 0.909) and ER (58% vs. 49%, P = 0.338). In left-sided colitis, both mesalazine formulations were equipotent regarding CR (66% vs. 67%; P = 0.843) but mesalazine granules were superior regarding ER (56% vs. 37%; P = 0.025). In proctosigmoiditis, mesalazine granules were significantly more effective than mesalazine tablets regarding CR (78% vs. 55% P < 0.001) and ER (67% vs. 43% P < 0.001). Furthermore, o.d. application of mesalazine granules was more effective than t.d.s. dosing in left-sided colitis (CR 73% vs. 62%, P = 0.181; ER 71% vs. 48% P = 0.005) and proctosigmoiditis (CR 86% vs. 73%, P = 0.020; ER 75% vs. 61%, P = 0.021), but not in pancolitis.
  
  
  CONCLUSIONS
  This pooled analysis supports the hypothesis that mesalazine granules are superior to mesalazine tablets in induction of remission in distal colitis and should be taken once daily.
authors.affiliation: Evangelisches Krankenhaus Kalk, Cologne, Germany. l.leifeld@gmx.de
authors.forename: L
authors.initials: L
authors.lastname: Leifeld
authors.forename: R
authors.initials: R
authors.lastname: Pfützer
authors.forename: J
authors.initials: J
authors.lastname: Morgenstern
authors.forename: P R
authors.initials: PR
authors.lastname: Gibson
authors.forename: Y
authors.initials: Y
authors.lastname: Marakhouski
authors.forename: R
authors.initials: R
authors.lastname: Greinwald
authors.forename: R
authors.initials: R
authors.lastname: Mueller
authors.forename: W
authors.initials: W
authors.lastname: Kruis
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D011109:Polymethacrylic Acids / Q000627:therapeutic use*; D011208:Powders / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D012720:Severity of Illness Index; D013223:Statistics as Topic; D013608:Tablets, Enteric-Coated / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011109:Polymethacrylic Acids; D011208:Powders; D013608:Tablets, Enteric-Coated; C038300:methylmethacrylate-methacrylic acid copolymer; D019804:Mesalamine