Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis.
BACKGROUND
Systemic corticosteroids are effective in ulcerative colitis but commonly cause side effects.


OBJECTIVE
To compare the safety and efficacy of a sparingly absorbed formulation of prednisolone metasulfobenzoate (Predocol) with a conventional tapering course of oral prednisolone.


METHODS
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).


CONCLUSIONS
Predocol 40 mg/day has similar efficacy but markedly fewer side effects than a conventional tapering prednisolone regimen (ISRCTN14133410).
Rhodes
J M
JM
School of Clinical Science, University of Liverpool, Liverpool, UK. rhodesjm@liverpool.ac.uk
Robinson
R
R
Beales
I
I
Pugh
S
S
Dickinson
R
R
Dronfield
M
M
Speirs
C J
CJ
Wilkinson
P
P
Wilkinson
S P
SP
D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D020551:Pulse Therapy, Drug; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; C013218:prednisolone 21-3-sulfobenzoate; D011239:Prednisolone