New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Coliti...(to clinical remissionin patients with mi...),Health

Date:10/15/2007

to clinical remission in patients with mildly and moderately active UC receiving 2.4 g/day of Asacol delayed-release tablets. Data from the 2.4 g/day active control arms of the ASCEND I and II studies was assessed. Clinical remission was defined as resolution (score=0) of both rectal bleeding (RB) and stool frequency (SF). Resolution of RB was defined as the absence of visible blood in stools. Resolution of SF was defined as a patients return to his/her normal number of stools per day. Patients had to have symptoms at baseline to be included in the analysis. Time to clinical remission was defined as the first day of three consecutive days of complete symptom resolution based on symptoms recorded by patients daily through an Interactive Voice Response System (IVRS).

In the two studies, 349 patients received 2.4 g/day. Based on IVRS data, the median time to clinical remission in patients with mildly and moderately active UC was 26 days (95% CI 24, 33).

About Ulcerative Colitis (UC)

UC involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease. Treatment depends on the extent and severity of disease.

UC causes flares followed by periods of remission. During a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares.

UC affects people of all ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection or the immune system.

About Asacol(R) (mesalamine) Delayed-Release Tablets 400 mg

Asacol is a delayed-release oral mesalamine tablet indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets tid for 6 we
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SOURCE The Procter & Gamble Company Copyright©2007 PR Newswire. All rights reserved

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