PMID- 18251152
OWN - NLM
STAT- MEDLINE
DCOM- 20080314
LR  - 20080206
IS  - 0172-6390 (Print)
IS  - 0172-6390 (Linking)
VI  - 54
IP  - 79
DP  - 2007 Oct-Nov
TI  - Budesonide in Crohn's disease: findings of a compassionate-use program.
PG  - 2024-7
AB  - 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.
FAU - Lyckegaard, E
AU  - Lyckegaard E
AD  - AstraZeneca R & D, Lund, Sweden. Eva.Lyckergaard@astrazeneca.com
FAU - Hakansson, K
AU  - Hakansson K
FAU - Bengtsson, B
AU  - Bengtsson B
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - Greece
TA  - Hepatogastroenterology
JT  - Hepato-gastroenterology
JID - 8007849
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Glucocorticoids)
RN  - 51333-22-3 (Budesonide)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Budesonide/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Consumer Product Safety
MH  - Crohn Disease/*drug therapy
MH  - Delayed-Action Preparations
MH  - Drug Approval/legislation & jurisprudence
MH  - Europe
MH  - Female
MH  - Glucocorticoids/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2008/02/07 09:00
MHDA- 2008/03/15 09:00
CRDT- 2008/02/07 09:00
PHST- 2008/02/07 09:00 [pubmed]
PHST- 2008/03/15 09:00 [medline]
PHST- 2008/02/07 09:00 [entrez]
PST - ppublish
SO  - Hepatogastroenterology. 2007 Oct-Nov;54(79):2024-7.