<p>Protective Effect of Asacol in Combination with Pantoprazole in Ulcerative Colitis Patients Who Defecate Asacol Tablets Intactly: A Clinical Trial Study</p>

Abstract

Purpose: Mesalazine formulations are the drug of choice in the treatment of ulcerative colitis (UC). They are released at alkaline pH in order to deliver 5-aminosalicylic acid to the colon. The colonic pH is significantly lower in UC patients than in normal patients. This study was conducted for the first time to evaluate the clinical efficacy of co-administration of pantoprazole and Asacol in the treatment of ulcerative colitis patients who excrete intact Asacol tablets in the feces. Patients and Methods: Thirty patients with mild-to-moderate active ulcerative colitis who reported passing intact Asacol tablets in stools received oral Asacol plus pantoprazole for 2 weeks. The demographic characteristics of the patients and the body mass index were collected through interviews. For each patient, the stool frequency, visible blood, and presence of intact Asacol tablets in the stool were compared before and pantoprazole treatment. Results: There was a significant difference in the stool frequency (number of daily stools) before and after pantoprazole treatment (mean ± sd, 6.06 ± 1.04 vs 1.5± 0.5; P<0.001). In addition, pantoprazole administration statistically reduced visible blood in the stool (100%; P<0.001). Co-administration of pantoprazole and Asacol was effective in all age groups and both sexes. None of the patients reported the presence of intact Asacol tablets in their stools. Conclusions: Co-administration of pantoprazole and Asacol would be useful for symptom management UC patients that excrete intact Asacol tablets in their feces through increasing the gastric pH and releasing the maximum concentration of the drug in the proximal gastrointestinal tract.