Original Contribution
The American Journal of Gastroenterology (2005) 100, 2478–2485; doi:10.1111/j.1572-0241.2005.00248.x
Delayed-Release Oral Mesalamine at 4.8 g/day (800 mg tablet) for the Treatment of Moderately Active Ulcerative Colitis: The ASCEND II Trial
Stephen B Hanauer MD1, William J Sandborn MD2, Asher Kornbluth MD3, Seymour Katz MD4, Michael Safdi MD5, Scott Woogen MD6, Gino Regalli MD, PhD7, Chyon Yeh PhD7, Nancy Smith-Hall PharmD, MD7 and Funmilay Ajayi MD7
- 1Division of Gastroenterology, University of Chicago Medical Center, Chicago, Illinois;
- 2Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota;
- 3Mount Sinai School of Medicine, New York, New York;
- 4Long Island Clinical Research Associates, Long Island, New York;
- 5Greater Cincinnati Gastroenterology Associates, Cincinnati, Ohio;
- 6Richmond Gastroenterology Associates, Richmond, Virginia;
- 7Procter & Gamble Pharmaceuticals, Mason, Ohio
Correspondence: Stephen B. Hanauer, MD, Division of Gastroenterology, University of Chicago Medical Center, 5841 South Maryland, Chicago, IL 60637
Received 23 February 2005; Revised 0000; Accepted 6 June 2005.
Abstract
BACKGROUND AND AIMS:
Preliminary data have shown that delayed release oral mesalamine (Asacol®) dosed at 4.8 g/day provided additional efficacy benefit compared to 1.6 g/day in patients with mildly to moderately active ulcerative colitis. Additionally, Asacol dosed at 2.4 g/day has been proved to be more effective than 1.6 g/day. Whether 4.8 g/day of mesalamine (dosed with an investigational 800 mg tablet) is more effective than Asacol 2.4 g/day (dosed with a 400 mg tablet) in patients with moderately active ulcerative colitis is unknown.
METHODS:
A randomized, double-blind, controlled trial (ASCEND II) was conducted to evaluate the efficacy of 4.8 g/day of mesalamine in adults with active ulcerative colitis. Three hundred eighty-six patients with mild to moderate ulcerative colitis were randomized for treatment with mesalamine 2.4 g/day (400 mg tablet) or 4.8 g/day (800 mg tablet) for 6 wk. The primary efficacy population was 268 patients with moderately active ulcerative colitis treated with 2.4 g/day (n = 139) or 4.8 g/day (n = 129). The primary endpoint was the proportion of patients in each treatment group that achieved overall improvement ("treatment success," defined as either complete remission or a clinical response to therapy) from baseline at week 6.
RESULTS:
Seventy-two percent of patients receiving 4.8 g/day of mesalamine for moderate ulcerative colitis (89/124 patients) achieved treatment success at week 6, compared with 59% of those who received 2.4 g/day (77/130 patients) (p= 0.036). Both regimens were well tolerated. Adverse events and clinically significant changes in laboratory results were similar in both treatment groups.
CONCLUSIONS:
Patients with moderately active ulcerative colitis treated with 4.8 g/day of mesalamine (800 mg tablet) are significantly more likely to achieve overall improvement at 6 wk compared to patients treated with 2.4 g/day.
