12 and 28 In addition, budesonide improves bile acid malabsorption, which might occur in a substantial number of patients with microscopic colitis, by up-regulating the bile acid transporter gene expression in the small bowel.29 and 30 Finally, there is evidence that budesonide improves the small intestine’s water-absorption capacity, lowering the ileostomy output in quiescent Crohn’s disease,31 and 32 as well as alleviating chemotherapy-induced diarrhea refractory to loperamide.33 Budesonide appears to exhibit an array of pharmacological mechanisms likely to contribute to its consistent clinical efficacy in microscopic colitis. Our study also confirms the safety of short-term

budesonide treatment by revealing no significant difference between the adverse-event rates of budesonide and placebo. Budesonide’s favorable selleck chemicals llc safety profile has also been documented in placebo-controlled studies on short-term treatment in collagenous and lymphocytic colitis,11, 12, 13, 34 and 35 as well as in studies addressing long-term treatment with budesonide in collagenous colitis.36 and 37 A meta-analysis of steroids in microscopic

colitis confirmed that in terms of adverse events, ZD1839 clinical trial budesonide was similar to placebo, and the incidence of adverse events with prednisolone was about 5 times that with placebo.21 In addition, a recent population-based US cohort study of 315 patients with microscopic colitis demonstrated a higher response rate to budesonide compared with prednisone and a lower relapse rate after budesonide therapy compared with prednisone therapy.38 Based on this body of data, the European Microscopic Colitis Group recently recommended budesonide as the treatment of choice for active microscopic colitis.39 The results of this study support the therapeutic value for this indication. Our study is the first to compare mesalamine with placebo in collagenous colitis. The clinical remission rate we observed with mesalamine resembles the experience

from large retrospective series.15, 16 and 17 However, there were no statistically significant differences from placebo in any of the efficacy criteria applied in our study, suggesting 3-oxoacyl-(acyl-carrier-protein) reductase that mesalamine is ineffective in collagenous colitis. In contrast, a prospective single-center study reported a clinical response in 8 of 9 patients with collagenous colitis taking 2.4 g mesalamine per day for 6 months.14 However, that finding remains difficult to appraise due to the lack of a placebo-control group. To shed more light on the value of mesalamine in microscopic colitis, our group is now conducting a randomized placebo-controlled, multicenter study to investigate mesalamine in lymphocytic colitis (ClinicalTrials.gov number, NCT01209208). The pharmacokinetic profile of the test medication budesonide (Budenofalk)40 and 41 differs from those of other commercially available budesonide preparations (eg, Entocort, Uceris).