Comparison of two different daily dosages (2.4 vs. 1.2 g) of oral mesalazine in maintenance of remission in ulcerative colitis patients: 1-year follow-up study.
BACKGROUND
Mesalazine as maintenance therapy in ulcerative colitis is used worldwide and has been proven to be effective. However, the optimal dosage remains to be defined.


OBJECTIVE
To establish whether daily treatment with 2.4 g of oral mesalazine is more effective than 1.2 g in preventing disease relapse.


METHODS
A total of 156 patients with ulcerative colitis in remission were randomly treated for 1 year with 2.4 (n = 80) or 1.2 (n = 76) g/day of mesalazine. Activity of disease was assessed by periodical clinical, endoscopic and histological examinations.


RESULTS
After 12 months, 24 of 80 patients (30%) on 2.4 g and 20 of 76 patients (26%) on 1.2 g were still in remission (P = N.S.). Patients in 2.4 g group remained in remission for a longer time than those in 1.2 g group (P < 0.001). Among clinical variables considered in the study, course of disease prior to enrollment (< or = 3 or > 3 relapses/year) was found to influence response to therapy.


CONCLUSIONS
A daily dosage of 2.4 g of oral mesalazine seems to better at preventing and delaying relapses of ulcerative colitis than 1.2 g. The course of disease seems to be crucial in choosing the optimal dosage of mesalazine in a maintenance regimen.
Paoluzi
O A
OA
Gastroenterology Unit, Department of Clinical Science, La Sapienza University, Rome, Italy. paolo.pauluzi@uniroma1.it
Iacopini
F
F
Pica
R
R
Crispino
P
P
Marcheggiano
A
A
Consolazio
A
A
Rivera
M
M
Paoluzi
P
P
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006801:Humans; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010349:Patient Compliance; D012008:Recurrence; D012074:Remission Induction; D016037:Single-Blind Method
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine