Kate McKeage1, Karen L Goa. 1. Adis International Limited, Mairangi Bay, Auckland, New Zealand. demail@adis.co.nz
Abstract
UNLABELLED: Budesonide (Entocort EC Capsules) is an oral corticosteroid with a high degree of topical activity and low systemic bioavailability (approximately 11%). This action is achieved by a high affinity for the glucocorticoid receptor and an extensive first-pass hepatic metabolism. The budesonide capsule has been formulated to dissolve in a pH dependent manner, delivering most of the drug to the ileum and ascending colon, areas of the intestine most commonly affected by Crohn's disease. In large (n > or = 176), well designed clinical trials of 10 to 12 weeks' duration in patients with active, mild to moderate Crohn's disease, budesonide (9 mg/day) was significantly more effective in inducing remission than placebo or mesalazine (mesalamine) slow release, and demonstrated similar efficacy to recommended dosages of prednisolone. Results of health-related quality-of-life assessments support clinical data, showing a significantly greater improvement among patients treated with budesonide than with placebo or mesalazine slow release. Oral budesonide was well tolerated in clinical trials of up to 16 weeks' duration. In these studies, the incidence of adverse events associated with budesonide (9 mg/day) was similar to that seen with placebo and mesalazine slow release. The rate of glucocorticoid-related adverse effects observed with budesonide was significantly less than that reported with prednisolone. CONCLUSION: Oral budesonide 9 mg/day offers efficacy that is superior to mesalazine slow release and placebo, and similar to prednisolone in the treatment of patients with active mild to moderate Crohn's disease involving the ileum and/or ascending colon. Budesonide is generally well tolerated and the incidence of adverse events is similar to that seen with placebo or mesalazine slow release. Glucocorticoid-related adverse effects are significantly less frequent during short-term therapy with budesonide than with prednisolone. Thus, for the medical management of patients with active mild to moderate Crohn's disease, oral budesonide has superior efficacy to mesalazine slow release and a more favourable tolerability profile than prednisolone.
UNLABELLED: Budesonide (Entocort EC Capsules) is an oral corticosteroid with a high degree of topical activity and low systemic bioavailability (approximately 11%). This action is achieved by a high affinity for the glucocorticoid receptor and an extensive first-pass hepatic metabolism. The budesonide capsule has been formulated to dissolve in a pH dependent manner, delivering most of the drug to the ileum and ascending colon, areas of the intestine most commonly affected by Crohn's disease. In large (n > or = 176), well designed clinical trials of 10 to 12 weeks' duration in patients with active, mild to moderate Crohn's disease, budesonide (9 mg/day) was significantly more effective in inducing remission than placebo or mesalazine (mesalamine) slow release, and demonstrated similar efficacy to recommended dosages of prednisolone. Results of health-related quality-of-life assessments support clinical data, showing a significantly greater improvement among patients treated with budesonide than with placebo or mesalazine slow release. Oral budesonide was well tolerated in clinical trials of up to 16 weeks' duration. In these studies, the incidence of adverse events associated with budesonide (9 mg/day) was similar to that seen with placebo and mesalazine slow release. The rate of glucocorticoid-related adverse effects observed with budesonide was significantly less than that reported with prednisolone. CONCLUSION: Oral budesonide 9 mg/day offers efficacy that is superior to mesalazine slow release and placebo, and similar to prednisolone in the treatment of patients with active mild to moderate Crohn's disease involving the ileum and/or ascending colon. Budesonide is generally well tolerated and the incidence of adverse events is similar to that seen with placebo or mesalazine slow release. Glucocorticoid-related adverse effects are significantly less frequent during short-term therapy with budesonide than with prednisolone. Thus, for the medical management of patients with active mild to moderate Crohn's disease, oral budesonide has superior efficacy to mesalazine slow release and a more favourable tolerability profile than prednisolone.
Authors: W J Tremaine; W J Sandborn; E V Loftus; M L Kenan; T M Petterson; A R Zinsmeister; M D Silverstein Journal: Am J Gastroenterol Date: 2001-08 Impact factor: 10.864
Authors: S R Targan; S B Hanauer; S J van Deventer; L Mayer; D H Present; T Braakman; K L DeWoody; T F Schaible; P J Rutgeerts Journal: N Engl J Med Date: 1997-10-09 Impact factor: 91.245
Authors: E V Loftus; M D Silverstein; W J Sandborn; W J Tremaine; W S Harmsen; A R Zinsmeister Journal: Gastroenterology Date: 1998-06 Impact factor: 22.682
Authors: F H Gordon; C W Lai; M I Hamilton; M C Allison; E D Srivastava; M G Fouweather; S Donoghue; C Greenlees; J Subhani; P L Amlot; R E Pounder Journal: Gastroenterology Date: 2001-08 Impact factor: 22.682
Authors: O O Thomsen; A Cortot; D Jewell; J P Wright; T Winter; F T Veloso; M Vatn; T Persson; E Pettersson Journal: N Engl J Med Date: 1998-08-06 Impact factor: 91.245
Authors: P Rutgeerts; R Löfberg; H Malchow; C Lamers; G Olaison; D Jewell; A Danielsson; H Goebell; O O Thomsen; H Lorenz-Meyer Journal: N Engl J Med Date: 1994-09-29 Impact factor: 91.245
Authors: Balakrishnan S Ramakrishna; Govind K Makharia; Vineet Ahuja; Uday C Ghoshal; Venkataraman Jayanthi; Benjamin Perakath; Philip Abraham; Deepak K Bhasin; Shobna J Bhatia; Gourdas Choudhuri; Sunil Dadhich; Devendra Desai; Bhaba Dev Goswami; Sanjeev K Issar; Ajay K Jain; Rakesh Kochhar; Goundappa Loganathan; Sri Prakash Misra; C Ganesh Pai; Sujoy Pal; Mathew Philip; Anna Pulimood; Amarender S Puri; Gautam Ray; Shivaram P Singh; Ajit Sood; Venkatraman Subramanian Journal: Indian J Gastroenterol Date: 2015-03-14