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New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Colitis Patients
Date:10/15/2007

Symptom resolution results based on stringent endpoint of clinical

remission is more clinically relevant, beneficial to patients

PHILADELPHIA, Oct. 15 /PRNewswire-FirstCall/ -- An analysis of data to be presented tomorrow at the American College of Gastroenterology (ACG) Annual Scientific Meeting found that Asacol, dosed at 2.4 g/day, provided rapid symptom relief in patients with mildly to moderately active ulcerative colitis (UC). The analysis was based on data pooled from the ASCEND I and II studies, which included 349 patients dosed at 2.4 g/day. Results indicated that the median time to clinical remission was 26 days. A subgroup of patients with mild UC saw a median time to clinical remission even faster, in 14 days. Time to clinical remission was defined as the first day of three consecutive days of resolution of both rectal bleeding and increased stool frequency.

The time to clinical remission endpoint utilized in this analysis represents a rigorous requirement. "If one only looks at the first day of symptom relief, the patient could relapse on the next day," said Dan Present, MD, co-author of the study and Clinical Professor of Medicine at the Mount Sinai Medical Center. "Sustained symptom resolution is what I want to provide my patients. Therefore, data supporting three consecutive days of complete resolution of symptoms is important to me."

A recent survey, published in Inflammatory Bowel Diseases, found that 97 percent of patients surveyed reported that a highly effective treatment is very important when choosing a treatment for UC.(1) "Speed of relief is a significant component of efficacy, and is a key treatment goal in active UC," said Dr. Present. "The data demonstrating speed to clinical remission further support Asacol as a trusted UC therapy that helps patients treat UC flares by rapidly bringing their symptoms under control."

Additional Study Details

The purpose of this analysis was to evaluate time
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SOURCE The Procter & Gamble Company
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