Salaza

ATC code: A07EC02 Mesalazine is thought to have a topical anti-inflammatory effect on the intestinal mucosa, where it has been shown to inhibit prostaglandin and leukotriene synthesis, release of reactive oxygen species and other actions. Moderately active ulcerative colitis: Two active-controlled trials enrolled a total of 687 patients comparing Asacol 4.8 g/day (800 mg formulation) with mesalazine enteric coated tablets 2.4 g/day (400 mg formulation) in patients with mildly to moderately active ulcerative colitis.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Both studies were of six weeks duration. Treatment success was defined on the basis of the Physician's Global Assessment (PGA), which took into consideration clinical assessments of rectal bleeding, stool frequency, and the patient's functional assessment and sigmoidoscopic examination. Across the two studies 4.8 g/day provided superior efficacy in patients with moderately active disease. In the first study a total of 301 patients with mildly to moderately active UC were enrolled. Of these, 169 patients with moderately active disease were assessed for efficacy in a pre-defined subgroup analysis. In these patients, 4.8 g/day gave greater treatment success than 2.4 g/day (72% treatment success compared with 57%). In the second study a total of 386 patients with mildly to moderately active ulcerative colitis were randomly assigned to treatment. In the 254 patients with moderately active disease, the pre-defined primary efficacy analysis showed that 4.8 g/day gave greater treatment success than 2.4 g/day (72% treatment success compared to 59%). In both studies, more patients showed improvement on 4.8 g/day compared to 2.4 g/day across the clinical assessments (stool frequency, rectal bleeding, sigmoidoscopy and PGA). In combined studies, 4.8 g/day showed statistically significant superiority in the sigmoidoscopy and PGA scores. At Week 3, more patients with moderately active disease achieved treatment success on 4.8 g/day compared with 2.4 g/day in each study and in the combined analysis (62% vs. 53%). These differences were not statistically significant. In combined studies among patients with moderately active disease, the efficacy benefit of 4.8 g/day over 2.4 g/day was consistent across various subgroups including age, gender, race, ulcerative colitis disease history, prior medication usage and extent of disease (proctitis, proctosigmoiditis, left-sided colitis and pancolitis).