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Budesonide in Crohn's disease: Findings of a compassionate-use program

Lyckegaard, E.; Håkansson, Katarina LU and Bengtsson, B. (2007) In Hepato-Gastroenterology 54(79). p.2024-2027
Abstract
Background/Aims: Budesonide controlled-release (CR) capsules are effective for inducing remission of Crohn's disease (CD) and are associated with fewer side effects than conventional corticosteroids. A compassionate-use program was implemented in countries where this treatment was unavailable. This paper reports the findings of this program. Methodology: Physicians were allowed to apply to AstraZeneca for a supply of budesonide CR capsules primarily for patients with CD who had experienced unacceptable side effects from conventional steroids or were unresponsive to other drugs. Physicians were requested to record adverse events (AEs) and patient response (1 = 'moderate'; 2 = 'well'; 3,very well'). Results: Four thousand and ninety-two... (More)
Background/Aims: Budesonide controlled-release (CR) capsules are effective for inducing remission of Crohn's disease (CD) and are associated with fewer side effects than conventional corticosteroids. A compassionate-use program was implemented in countries where this treatment was unavailable. This paper reports the findings of this program. Methodology: Physicians were allowed to apply to AstraZeneca for a supply of budesonide CR capsules primarily for patients with CD who had experienced unacceptable side effects from conventional steroids or were unresponsive to other drugs. Physicians were requested to record adverse events (AEs) and patient response (1 = 'moderate'; 2 = 'well'; 3,very well'). Results: Four thousand and ninety-two patients were enrolled. There were 232 AE reports involving 326 different symptoms. There were 138 serious AEs (mainly gastrointestinal), and four deaths. Ten serious AEs were considered related to budesonide (no deaths). Budesonide was discontinued as a result of AEs in 147 patients (75 due to serious AEs, mainly gastrointestinal). Efficacy data were obtained from 1188 patients, with 943 (79%) responding 'well' or,very well'. In the subgroups of patients that were young, elderly, or had unsuccessfully received immunosuppressants previously, the mean patient response score was > 2. Conclusions: In a normal clinical setting, budesonide CR capsules were well tolerated by patients with ileocecal CD. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
tolerability, safety, elderly, efficacy, Crohn's disease, corticosteroids, budesonide, controlled-release, long-term
in
Hepato-Gastroenterology
volume
54
issue
79
pages
2024 - 2027
publisher
Georg Thieme Verlag
external identifiers
  • wos:000251892700029
  • scopus:37749040258
ISSN
0172-6390
language
English
LU publication?
yes
id
d21bd775-1be3-4d93-b255-1be35f2e69c2 (old id 1409084)
date added to LUP
2009-06-01 16:59:46
date last changed
2017-01-01 07:16:19
@article{d21bd775-1be3-4d93-b255-1be35f2e69c2,
  abstract     = {Background/Aims: Budesonide controlled-release (CR) capsules are effective for inducing remission of Crohn's disease (CD) and are associated with fewer side effects than conventional corticosteroids. A compassionate-use program was implemented in countries where this treatment was unavailable. This paper reports the findings of this program. Methodology: Physicians were allowed to apply to AstraZeneca for a supply of budesonide CR capsules primarily for patients with CD who had experienced unacceptable side effects from conventional steroids or were unresponsive to other drugs. Physicians were requested to record adverse events (AEs) and patient response (1 = 'moderate'; 2 = 'well'; 3,very well'). Results: Four thousand and ninety-two patients were enrolled. There were 232 AE reports involving 326 different symptoms. There were 138 serious AEs (mainly gastrointestinal), and four deaths. Ten serious AEs were considered related to budesonide (no deaths). Budesonide was discontinued as a result of AEs in 147 patients (75 due to serious AEs, mainly gastrointestinal). Efficacy data were obtained from 1188 patients, with 943 (79%) responding 'well' or,very well'. In the subgroups of patients that were young, elderly, or had unsuccessfully received immunosuppressants previously, the mean patient response score was > 2. Conclusions: In a normal clinical setting, budesonide CR capsules were well tolerated by patients with ileocecal CD.},
  author       = {Lyckegaard, E. and Håkansson, Katarina and Bengtsson, B.},
  issn         = {0172-6390},
  keyword      = {tolerability,safety,elderly,efficacy,Crohn's disease,corticosteroids,budesonide,controlled-release,long-term},
  language     = {eng},
  number       = {79},
  pages        = {2024--2027},
  publisher    = {Georg Thieme Verlag},
  series       = {Hepato-Gastroenterology},
  title        = {Budesonide in Crohn's disease: Findings of a compassionate-use program},
  volume       = {54},
  year         = {2007},
}