Clinical trial: oral prednisolone metasulfobenzoate (predocol) versus oral prednisolone for active ulcerative colitis

Rhodes, J. M., Robinson, R., Beales, I., Pugh, S., Dickinson, R., Dronfield, M., Speirs, C. J., Wilkinson, P. and Wilkinson, S. R. (2008) Clinical trial: oral prednisolone metasulfobenzoate (predocol) versus oral prednisolone for active ulcerative colitis. Alimentary Pharmacology and Therapeutics, 27 (3). pp. 228-240. ISSN 1365-2036

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Background: Systemic corticosteroids are effective in ulcerative colitis but commonly cause side effects. Aim: To compare the safety and efficacy of a sparingly absorbed formulation of prednisolone metasulfobenzoate (Predocol) with a conventional tapering course of oral prednisolone. Method: In a double-blind randomized study, 59 active ulcerative colitis patients received Predocol 40 mg/day for 6 months, 61 received Predocol 60 mg/day for 6 months and 61 received prednisolone 40 mg/day for 2 weeks, tapered to week 8, followed by placebo until 6 months. Results: Steroid-related side effects assessed using a 10-cm visual analogue scale were fewer at 2 months with Predocol 40 mg [VAS 8.1 cm (2.6), mean (s.d.)], or 60 mg [8.1 (2.1)] compared with prednisolone [6.7 (2.7); P = 0.01]. Mood changes affected 43% receiving prednisolone at 4 weeks vs. 8% for Predocol 40 mg (P = 0.001). Remission rates (Powell-Tuck ≤2) at 2 months were Predocol 40 mg 46%, Predocol 60 mg 28% and tapering prednisolone 41% (P = 0.13). Visual analogue scale for efficacy also showed non-inferiority for Predocol 40 mg/day. Remission rates at 6 months were Predocol 40 mg 51%, Predocol 60 mg 38% and tapering prednisolone 32% (P = 0.08). Conclusion: Predocol 40 mg/day has similar efficacy but markedly fewer side effects than a conventional tapering prednisolone regimen (ISRCTN14133410).

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Gastroenterology and Gut Biology
Depositing User: EPrints Services
Date Deposited: 25 Nov 2010 11:10
Last Modified: 13 Jul 2024 00:21
DOI: 10.1111/j.1365-2036.2007.03569.x

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