Mesalazine granules are superior to Eudragit-L-coated mesalazine tablets for induction of remission in distal ulcerative colitis – a pooled analysis L. Leifeld*, R. Pfu ¨tzer*, J. Morgenstern*, P. R. Gibson   , Y. Marakhouski à , R. Greinwald § , R. Mueller § & W. Kruis* *Evangelisches Krankenhaus Kalk, Cologne, Germany.   Eastern Health Clinical School, Monash University, Box Hill, Vic., Australia. à Belarusian Medical Academy of Post-graduate Education, Gastroenter- ology Centre, Minsk, Belarus. § Dr. Falk Pharma GmbH, Department of Clinical Research & Development, Freiburg, Germany. Correspondence to: Dr L. Leifeld, Evangelisches Krankenhaus Kalk, Buchforststrasse 2, D-51103 Cologne, Germany. E-mail: l.leifeld@gmx.de Publication data Submitted 10 May 2011 First decision 31 May 2011 Resubmitted 8 August 2011 Accepted 12 August 2011 SUMMARY Background Different oral formulations of ‘mesalazine (mesalamine)’ may have different efficacy in distal ulcerative colitis. Aim To evaluate the efficacy of mesalazine granules (Salofalk granules) vs. me- salazine tablets (Salofalk tablets) as induction therapy in patients with dis- tinct extensions of ulcerative colitis. Methods A pooled analysis of 705 patients from four prospective, randomised, dou- ble-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 regard- ing 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. Conclusion 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. Aliment Pharmacol Ther ª 2011 Blackwell Publishing Ltd 1 doi:10.1111/j.1365-2036.2011.04840.x Alimentary Pharmacology and Therapeutics