Budesonide for the treatment of ulcerative colitis

Abstract

Introduction Budesonide is a synthetic corticosteroid characterized by enhanced topical potency and limited systemic bioavailability. Its use in ulcerative colitis (UC) was limited to rectal preparations until recently when the new oral budesonide formulation incorporating the multi-matrix system technology was introduced. The purpose of this review is to evaluate the current role of oral and rectal budesonide in managing UC patients Areas Covered In this paper, we described the chemical structure and pharmacologic characteristics of the different oral and rectal budesonide preparations, provided a summary of the published trials that evaluated the efficacy and safety of budesonide in UC, and discussed the current status of its use in this population Expert Opinion Budesonide is effective in inducing remission in a subset of patients with mild-moderate UC. Nevertheless, the current evidence suggests inferiority of oral budesonide to 5-aminosalisylates (5-ASA) and systemic steroids, whereas rectal applications are comparable to other rectal steroid preparations but still inferior to rectal 5-ASA. In clinical practice, several issues need clarification including, its exact position in the line of induction agents; the role of combining budesonide and 5-ASAs; the role of combining oral and rectal budesonide; and the role of budesonide in maintenance therapy.

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

“…This may be due to the scarce or contrasting literature produced until now in terms of RCTs for these second-generation steroids. It is noteworthy that while there is no direct comparison to systemic steroids for budesonide [51], the efficacy and safety of oral prolonged release BDP vs. oral PD is well established in a controlled trial [24], but data were published after guidelines.…”

“…Thanks to this extensive first-pass metabolism, BDP has a limited impact on the HPA axis with fewer systemic effects than traditional CSs [52]. Interestingly, morning plasma cortisol levels seem to have a dose-dependent decrease in BDP and budesonide [30,51]. If confirmed, this does call into question whether the ‘second-generation’ of topically acting steroids have safety advantages with dosage higher than 5 mg/day compared to systemic CSs.…”

Glucocorticoids in the Treatment of Glomerular Diseases

“…Budesonide is a nonabsorbable steroid acting locally in the small intestine. It has a low oral bioavailability due to high first pass hepatic metabolism (28). A preliminary trial showed that a 9-month treatment with budesonide is effective in patients with IgA nephropathy (29).…”

Treatment-resistant severe capecitabine-induced diarrhoea resolved with oral budesonide

“…Budesonide is an oral, synthetic glucocorticoid that undergoes extensive first-pass metabolism in the liver resulting in low systemic bioavailability while retaining a high degree of topical activity within the small bowel and colon 6. This allows for a potent, local glucocorticoid effect in the small bowel and colon while minimising the adverse effects seen with prednisone and other systemic glucocorticoid therapies, such as adrenal axis disturbances and loss of bone mineral density 6. While commonly used in inflammatory bowel disease, budesonide is very rarely used in CID.…”