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Clinical trial: controlled, open, randomized multicentre study comparing the effects of treatment on quality of life, safety and efficacy of budesonide or mesalazine enemas in active left‐sided ulcerative colitis
Author(s) -
Hartmann F.,
Stein J.
Publication year - 2010
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.1365-2036.2010.04354.x
Subject(s) - mesalazine , budesonide , medicine , enema , ulcerative colitis , gastroenterology , randomized controlled trial , population , corticosteroid , disease , environmental health
Aliment Pharmacol Ther 2010; 32: 368–376 Summary Background Therapy for active left‐sided ulcerative colitis usually involves topical application of mesalazine (mesalamine) or budesonide. Aim To compare the efficacy and safety of budesonide enema and mesalazine enema in the treatment of active left‐sided ulcerative colitis. Methods A total of 237 patients with mild–moderate ulcerative colitis were randomized open 1:1 to receive either budesonide ( n = 118) or mesalazine enemas ( n = 119) for 8 weeks. Efficacy variables were clinical activity index, endoscopic, histological index and IBDQ scores after 4 and 8 weeks. Results Clinical remission (intention‐to‐treat analysis) at week 4 was 63.5% for budesonide enemas and 77.2% for mesalazine enemas ( P < 0.05). The respective values for the per protocol population (PP) were 59.9% examined in the budesonide group and 77.5% in the mesalazine group ( P < 0.02). At the final visit (W8), clinical remission was diagnosed in the ITT analysis for 64.4% of the budesonide group and 77.4% of the mesalazine group ( P < 0.05). The respective values for the PP analysis were 59.5% in the budesonide group and 75.3% in the mesalazine group ( P < 0.02). Conclusions Compared with budesonide, mesalazine enema was associated with a significantly higher remission rate; this was supported by favourable trends in endoscopic, histological remission rates and the IBDQ score.