Budesonide for The Treatment of Collagenous Colitis: First Results of A Pilot Trial

Abstract

With respect to the preliminary data from this pilot trial, budesonide with its high topical and low systemic effects seems to be of therapeutic clinical benefit in collagenous colitis. A therapeutic effect could be demonstrated for both therapeutic goals, the clinical response and morphological changes. Further studies on the effects of budesonide on mucosal collagen metabolism and long-term follow-up are warranted.

Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis

“…This is in accordance with previous open studies 8 9 and a recently published placebo controlled trial. 10 Collagenous colitis is characterised by watery diarrhoea and in the present study up to 10 bowel movements a day were found.…”

Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial

“…The selection of the budesonide dose for the induction of clinical remission was based on previous studies in which budesonide 9 mg/day was shown to be optimal in terms of the treatment of patients with collagenous colitis 9 – 13. The maintenance dose was selected on the basis of previous studies of budesonide for maintenance therapy in patients with Crohn’s disease, which have demonstrated that budesonide 6 mg/day for up to 12 months was both well tolerated and efficacious for maintaining clinical remission 20 – 22…”

“…Coupled with almost complete first-pass metabolism in the liver, leading to low systemic exposure, it has favourable tolerability when administered by mouth 8. After preliminary indications of therapeutic potential,9 the efficacy and tolerability of oral budesonide for the induction of remission of collagenous colitis has been confirmed in a number of randomised, placebo-controlled studies 10 – 13. Indeed, treatment with budesonide 9 mg/day for up to 8 weeks achieved clinical remission in a significantly greater proportion of patients compared with placebo.…”

Microscopic Colitis

“…Budesonide is a potent synthetic steroid with high first‐pass hepatic metabolism, resulting in low systemic bioavailability and less risk of side effects, that has been effective in anecdotal and controlled reports in patients with microscopic colitis. 27,74–76,164–166 In 3 placebo‐controlled trials including 74 patients with collagenous colitis, the response rate in those treated with budesonide ranged from 57% to 100% (mean 76%), which was superior to the response to placebo in each study. 74–76 Surprisingly, the response rate in the trial using the colon‐specific formulation was lower than that in either study using the controlled ileal release formulation that is available in the United States.…”