A double-blind dose-escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative colitis.
BACKGROUND
Mesalazine as the treatment standard for ulcerative colitis can be applied in different galenical preparations.


OBJECTIVE
A novel formulation of mesalazine pellets with delayed and prolonged release characteristics was compared with conventional Eudragit L-coated tablets. Furthermore, the effect of mesalazine dose escalation on nonresponders was evaluated in both treatment groups.


METHODS
A total of 233 patients with mild to moderately active ulcerative colitis were randomized to receive either mesalazine (1.5 g/day in three doses) as pellets (n = 115) or tablets (n = 118) for 8 weeks. At insufficient response, the dose was increased to 3.0 g.


RESULTS
The clinical remission rate (clinical activity index < or = 4) for pellets was 67% vs. 68% for tablets which statistically proved to be not inferior (significance level alpha = 2.5%). In patients without dose increase, the remission rate was 47% (pellets) vs. 42% (tablets). Endoscopic improvement was observed in 80% (pellets) vs. 83% (tablets), and histological improvement in 48% (pellets) vs. 52% (tablets) of patients.


CONCLUSIONS
Mesalazine pellets are as effective as tablets in the treatment of mild to moderately active ulcerative colitis. Dose escalation to 3.0 g/day is a valid option for nonresponders to a starting dose of 1.5 g/day.
Marakhouski
Y
Y
Department of Gastroenterology and Nutrition, Byelorussian Medical Academy Postgraduate Education, Minsk, Republic of Belarus.
Fixa
B
B
Holomán
J
J
Hulek
P
P
Lukas
M
M
Bátovský
M
M
Rumyantsev
V G
VG
Grigoryeva
G
G
Stolte
M
M
Vieth
M
M
Greinwald
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D012008:Recurrence; D013607:Tablets; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D019804:Mesalamine