Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis.

Abstract

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 < or =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).

• Authors: J M Rhodes, R Robinson, I Beales, S Pugh, R Dickinson, M Dronfield, C J Speirs, P Wilkinson, S P Wilkinson
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 27 Issue 3 Pg. 228-40 (Feb 01 2008) ISSN: 1365-2036 [Electronic] England
• PMID: 17988236 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• prednisolone 21-3-sulfobenzoate
• Prednisolone

Topics

• Adult
• Aged
• Anti-Inflammatory Agents (administration & dosage, adverse effects)
• Chi-Square Distribution
• Colitis, Ulcerative (drug therapy)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Prednisolone (administration & dosage, adverse effects, analogs & derivatives)
• Pulse Therapy, Drug
• Statistics, Nonparametric
• Treatment Outcome