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Rapid Symptom Resolution With Delayed Release Mesalamine in Mildly and Moderately Active Ulcerative Colitis: Presented at ACG

By Danny Kucharsky

PHILADELPHIA, PA -- October 24, 2007 -- Patients with mild and moderate ulcerative colitis who received 2.4 g daily of mesalamine delayed-release tablets obtain rapid symptom relief, according to an analysis of two multicentre, randomised, double-blind, active-controlled trials studies presented here at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

Researchers led by William Sandborn, MD, Professor of Medicine, Mayo College of Medicine, Rochester, Minnesota, United States, combined and analysed data involving 687 patients with mild and moderate ulcerative colitis.

The analysis evaluated time to clinical remission, defined as resolution of both rectal bleeding and increased stool frequency. Time to clinical remission was defined as the first day of 3 consecutive days of complete symptom resolution based on symptoms recorded by patients daily through an integrated voice response system.

Study subjects were randomised in the two studies; 349 patients received 2.4 g daily of mesalamine delayed-release tablets.

Median time to clinical remission was 26 days. Time to complete resolution of rectal bleeding among patients with mild and moderate ulcerative colitis was 15 days (n=293) and for stool frequency was 21 days (n=319).

Patients with mildly active ulcerative colitis patients responded sooner to therapy than those with moderately active ulcerative colitis. Among patients with mild ulcerative colitis, the time to complete resolution of rectal bleeding was 4 days and of stool frequency it was 10 days. For moderate ulcerative colitis, the times were 21 and 26 days, respectively.

Adverse events were consistent with those described in the current prescribing information for mesalamine delayed-release tablets, said Dr. Sandborn. In pivotal studies of active ulcerative colitis, the most frequent adverse effects reported for mesalamine delayed-release tablets were headache, abdominal pain, eructation, pain and nausea.

The results are promising, Dr. Sandborn said, given that in active ulcerative colitis, rapid symptom relief is a key treatment goal.

Funding for this study was provided by Procter & Gamble.


[Presentation title: Rapid Symptom Resolution With Delayed Release Mesalamine in Mildly and Moderately Active UC. Abstract 948]

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