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Mesalazine granules are superior to Eudragit‐L‐coated mesalazine tablets for induction of remission in distal ulcerative colitis – a pooled analysis
Author(s) -
Leifeld L.,
Pfützer R.,
Morgenstern J.,
Gibson P. R.,
Marakhouski Y.,
Greinwald R.,
Mueller R.,
Kruis W.
Publication year - 2011
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2011.04840.x
Subject(s) - mesalazine , medicine , ulcerative colitis , colitis , gastroenterology , pharmacology , disease
Aliment Pharmacol Ther 2011; 34: 1115–1122 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. 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. 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.