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Note from CCFA's National Scientific Advisory Committee: Once daily granular sachets are not yet available in the U.S.
Last Updated: 2009-01-30 17:50:19 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In patients with mild to moderate active ulcerative colitis, taking 3 grams of mesalazine granules once daily is as safe and effective as taking 1 gram 3 times daily, according to results of a randomized, double-blind, European multicenter study.
"With respect to the best possible adherence of the patients to the treatment, once daily dosing of mesalazine should be the preferred application mode in active ulcerative colitis," the researchers conclude in the February issue of the journal Gut.
In the study, 380 patients with established or first attack of ulcerative colitis were randomized to 8 weeks of either 3 grams once daily or 1 gram tid mesalazine granules.
"Both dosing regimens showed similar therapeutic effects, with 79% and 76% of the patients in the once daily and tid groups, respectively, achieving clinical remission," Dr. W. Kruis from University of Cologne, Germany, and colleagues report.
Roughly 70% of patients in both treatment arms achieved endoscopic remission and 35% in the once daily arm and 41% in the tid arm achieved histological remission.
It's of interest, the researchers say, that significantly more patients with proctosigmoiditis achieved clinical remission in the once daily group than the tid group (86% vs 73%).
Dr. Kruis and colleagues hypothesize that once daily dosing "leads to higher luminal peak concentrations, particularly in the distal colon, and that a once daily dosing of mesalazine granules is well suited for oral treatment of distal disease and thus might also enhance a patient's compliance to treatment."
Eighty percent of all patients preferred once daily dosing mesalazine dosing.
Similar numbers of adverse events occurred in the once daily group and the tid group, "indicating that the two dosing regimens were equally safe and well tolerated," Dr. Kruis and colleagues report.
Gut 2009;58:233-240.
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