Efficacy of Asacol

Quality of Life

Asacol Delivered Significant Improvement in QoL—in as Few as 3 Weeks

According to the ACG Guidelines, improving Quality of Life (QoL) is a key goal of therapy in active ulcerative colitis.1

Improvement in Total IBDQ Score

QoL measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)*

  • 32 questions with graded responses (1 to 7 points) examining four aspects of patients' lives
  • Scores range from 32 to 224 (higher scores are associated with better QoL)
  • Increase in total IBDQ score >20 points is associated with clinically significant improvement3

* Inflammatory Bowel Disease Questionnaire (IBDQ) is copyrighted by McMaster University.

References: 1. Kornbluth A et al. Am J Gastroenterol. 2004;99:1371-1385. 2. Sninsky CA et al. Gastroenterology & Hepatology. 2008;4(suppl 4):1-10. 3. Higgins PDR et al. Gut. 2005;54:782-788.

Asacol Delivered Significant Improvement in QoL—Including Social Function Domain

According to the ACG Guidelines, improving Quality of Life (QoL) is a key goal of therapy in active ulcerative colitis.1

Significant QoL improvement vs. baseline as measured by IBDQ across all four domains at 3 and 6 weeks

References: 1. Kornbluth A et al. Am J Gastroenterol. 2004;99:1371-1385. 2. Data on file, Procter & Gamble Pharmaceuticals, Inc. 3. Sninsky CA et al. Gastroenterology & Hepatology. 2008;4(suppl 4):1-10.

Selected Safety Information

Asacol is indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets tid for 6 weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses).

In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35% vs 36%), abdominal pain (18% vs 14%), and eructation (16% vs 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs 50%), rhinitis (42% vs 36%) , and diarrhea (35% vs 50%).

Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. Serious adverse events may occur with Asacol.

Please see accompanying full prescribing information by clicking the link above.


This information was printed from Asacol.com.
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