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Double-dose Asacol improves outcomes in ulcerative colitis.

ORLANDO, FLA. -- A daily 4.8-g dose of mesalamine is safe and significantly more effective than the standard 2.4-g dose for the treatment of moderately active ulcerative colitis, William J. Sandborn, M.D., reported at the annual meeting of the American College of Gastroenterology.

A total of 268 patients were randomized to receive either a 4.8-g daily dose, delivered using a new 800-mg tablet formulation, or the standard 2.4-g daily dose, delivered using 400-mg tablets and approved for this indication in 1992. After 6 weeks, treatment success, defined as complete or partial response upon clinical and endoscopic assessment, occurred in 72% of patients in the higher-dose group, compared with 59% of those in the lower-dose group, said Dr. Sandborn of the Mayo Clinic, Rochester, Minn.

Patients in the multicenter, double-blind study had moderately active ulcerative colitis with a confirmed diagnosis in the 24 months prior to study initiation, and those in both groups were comparable in regard to disease severity and demographic characteristics. The higher dose was not associated with any increase in the incidence or severity of adverse events associated with treatment, which typically include headache, gastrointestinal symptoms, and respiratory symptoms.

If approved, the new 800-mg mesalamine tablet (marketed as Asacol by Procter & Gamble Pharmaceuticals, which sponsored this study), will offer patients a more convenient option and could reduce the need for steroid treatment, Dr. Sandborn said, noting that the many patients currently take 12 pills per day using the 400-mg tablets.
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Title Annotation:Gastroenterology
Publication:Internal Medicine News
Article Type:Brief Article
Geographic Code:1USA
Date:Dec 1, 2004
Words:246
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