Efficacy of Asacol

Efficacy by Extent of UC

Asacol Delivers Rapid Efficacy Even in Proctitis—Patients with All Extents of Ulcerative Colitis Improved in as Few as 3 Weeks

Patients with the most distal extent of UC are often considered difficult to treat with oral 5-ASA therapy alone.

Improvement in Symptoms and Muscosal Healing in Proctitis Patients
  • Mucosal healing defined as an endoscopy subscore of 0 or 1.
  • Analysis includes patients with endoscopy subscore ≥2 at baseline.

* Data pooled from two randomized clinical studies using Asacol 2.4 g/day as active control arm.

† Retrospective analysis of data pooled from two randomized clinical studies using Asacol 2.4 g/day as the active control arm.

References: 1. Data on file, Procter & Gamble Pharmaceuticals, Inc. 2. Sninsky CA et al. Gastroenterology & Hepatology. 2008;4(suppl 4):1-10. 3. Loftus EV et al. Gut. 2000;46:336-343.

Asacol Delivers Rapid Improvement in Stool Frequency—in All Extents of Ulcerative Colitis

Efficacy throughout the colon is important when choosing an ulcerative colitis therapy.

Improvement in Stool Frequency at 3 and 6 Weeks

References: 1. Data on file, Procter & Gamble Pharmaceuticals, Inc. 2. Sninsky CA et al. Gastroenterology & Hepatology. 2008;4(suppl 4):1-10.

Asacol Delivers Rapid Improvement in Rectal Bleeding—in All Extents of Ulcerative Colitis

Efficacy throughout the colon is important when choosing a ulcerative colitis therapy.

Improvement in Rectal Bleeding at 3 and 6 Weeks

References: 1. Data on file, Procter & Gamble Pharmaceuticals, Inc. 2. Sninsky CA et al. Gastroenterology & Hepatology. 2008;4(suppl 4):1-10.

Asacol Delivers Rapid Mucosal Healing—in All Extents of Ulcerative Colitis

Efficacy throughout the colon is important when choosing a UC therapy.

Mucosal Healing at 3 and 6 Weeks
  • Mucosal healing defined as an endoscopy subscore of 0 or 1
  • Analysis includes patients with an endoscopy subscore ≥2 at baseline

References: 1. 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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