Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis.
BACKGROUND
There are no comparative studies of coated mesalazine.


OBJECTIVE
To compare the efficacy and tolerability of Eudragit-L- and ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis.


METHODS
A double-blind, double-dummy, randomized parallel group trial was performed across 18 centres in Australia, and 20 in Eastern Europe. Patients were treated with 3 g mesalazine for 8 weeks with the primary efficacy end point being clinical remission.


RESULTS
Of 215 patients, 69% achieved clinical remission in both treatment groups (P < 0.001; chi-square test) with no differences in frequency of adverse events. In the Australian cohort (n = 63), the Eudragit-L group had a higher remission rate (73% vs. 36%) and responded 13 days faster, compared with those in the European group (67% vs. 84%, and 2 days respectively). No clear reasons for differences in treatment responses were identified.


CONCLUSIONS
Eudragit-L and ethylcellulose-coated mesalazine tablets are well tolerated and equally effective in achieving remission in mild-moderately active ulcerative colitis over 8 weeks.
The Royal Melbourne Hospital, Melbourne, Vic, Australia. peter.gibson@med.monash.edu.au
P R
PR
Gibson
B
B
Fixa
B
B
Pekárková
M
M
Bátovský
G
G
Radford-Smith
J
J
Tibitanzl
L
L
Gabalec
T H J
TH
Florin
R
R
Greinwald
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D002482:Cellulose / Q000031:analogs & derivatives; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011109:Polymethacrylic Acids; D012720:Severity of Illness Index; D013607:Tablets; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011109:Polymethacrylic Acids; D013607:Tablets; C038300:methylmethacrylate-methacrylic acid copolymer; D019804:Mesalamine; D002482:Cellulose