BUDESONIDE, ALTRI IMPIEGHI -...
Transcript of BUDESONIDE, ALTRI IMPIEGHI -...
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SIMPOSIO SATELLITE
BUDESONIDE: ALTRE INDICAZIONI
DR.RAFFAELLO SOSTEGNIUOA GASTROENTEROLOGIA
OSPEDALE MAURIZIANO UMBERTO ITORINO
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BUDESONIDE:ALTRI IMPIEGHI• Rettocolite ulcerosa
• Pouchite
• Riduzione out-put fecale in pazienti portatori di ileostomia con Malattia di Crohn
• Colite collagena
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BUDESONIDE:ALTRI IMPIEGHI• Rettocolite ulcerosa
• Pouchite
• Riduzione out-put fecale in pazienti portatori di ileostomia con Malattia di Crohn
• Colite collagena
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COLITI DISTALI
-127+11δPlasma cortisolo(mmol/L)
7593Miglioramento (%)
2452Remissione completa (%)
447 + 89446 + 91Cortisolo plasmdopo 4 sett. (mmol/L)
8035Fallimenti (%)
Prednisolone31 mg(n=28)
Budesonide2 mg
(n=20)
Placebo(n=20)
Budesonide2 mg
(n=20)
Danielsson et al. Scand J Gastroenterol 1987
Danielsson et al. Scand J Gastroenterol 1992
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PROCTOSIGMOIDITE ULCEROSA
97Tempo alla risposta (gg)
3752Refrattari 5-ASA (%)
525050
525948
RispostaClinica (%)Endoscopica (%)Istologica (%)
Idrocortisone100 mg
Budesonide 2 mg
Bar Mair et al. Dis Colon Rectum 2003
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55--ASA IN ACTIVE DISTAL UCASA IN ACTIVE DISTAL UC
5-ASA better
5-ASA better
vs placebo
vs topical steroids
Marshall JK et al. Am J Gastroenterol 2000; 95: 1628-1636
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PANCOLITI E COLITI SX• Budesonide 10 mg (formulazione a rilascio
controllato); 40 mg Prednisolone• 34 pz. gruppo Budesonide, 38 pz. gruppo
Prednisolone• Miglioramento significativo dello score
endoscopico in entrambi i gruppi senza differenze tra loro
• Soppressione dei livelli di cortisolo nel gruppo prednisolone, immodificati nel gruppo budesonide
Lofberg et al. Gastroenterology 1996
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BUDESONIDE:ALTRI IMPIEGHI• Rettocolite ulcerosa
• Pouchite
• Riduzione out-put fecale in pazienti portatori di ileostomia con Malattia di Crohn
• Colite collagena
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Pouchitis: Definition
Nonspecific inflammation of the ileal reservoir
resulting in variable clinical symptoms
Pouchitis is a well-recognized long-term
complication of restorative proctocolectomy
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AIM OF THE STUDY
To evaluate the efficacy of oral budesonide in inducingremission and improuvingquality of life in patients withchronic refractory pouchitis
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Study design
n= 16Open-label, single-center studyPatients with active pouchitis (PDAI score≥7) not responding after 1 month of antibiotictreatment (metronidazole 1g/day or ciprofloxacin 1g/day)Treatment: Budesonide CIR 9 mg/daily for 8 weeks with tapering of 3 mg/monthlyEnd-points: remission= clinical PDAI score ≤2 and endoscopic PDAI score ≤1; IBDQ at weeks 0,2,4,6,8
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Results
0
3
6
9
12
15
18
Baseline 8 weeks
PDA
I
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PDAI score variation
1 (1-4)*5 (3-6)Histologic
1 (1-3)*5 (3-6)Endoscopic
1 (0-3)*3 (2-4)Clinical
3 (2-9)**13 (8-16)Total
8 wksbaselinePDAI score
Results expressed as median (range) ** p< 0.001, * p< 0.002
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IBDQ score variation250
maximum score 224
Baseline 2 4 6 80
50
100
150
IBD
Q sc
ore
200182180
170145
102
minimum score 32
(weeks)
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Conclusions
Budesonide 9mg/day for 8 weeks:
is effective in the treatment of chronicrefractory pouchitisimproves quality of lifeis safe and well tolerated
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BUDESONIDE: ALTRI IMPIEGHI• Rettocolite ulcerosa
• Pouchite
• Riduzione out-put fecale in pazienti malattia di Crohn e portatori di ileostomia
• Colite collagena
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Ecker KW et al. Dis Colon Rectum 2005
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Ecker KW et al. Dis Colon Rectum 2005
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BUDESONIDE: ALTRI IMPIEGHI• Rettocolite ulcerosa
• Pouchite
• Riduzione out-put fecale in pazienti malattia di Crohn e portatori di ileostomia
• Colite collagena
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COLITI MICROSCOPICHE“…inflammation in colon biopsy specimens from patients withchronic diarrhea and normal findings from colonoscopy and bariumenema….”
“…microscopic colitis is considered to be an umbrella term, with the following 2 subsets:collagenous colitis with a thickened subepithelialcollagen band; and lymphocytic colitis, without collagen thickening”
Colite linfocitica Colite collagenaPardi DS Microscopic colitis: an update; Inflamm Bowel Dis 2004
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COLLAGENOUS COLITIS• A diffusely distribuited and thickened subepithelialcollagen layer > 10 µm
•Epithelial damage such as flattening and detachment
•Inflammation in the lamina propria with mainly mononuclear cells
•Increased number of intraepithelial lymphocytes may be present
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51 (5%)1018 (15%)6701Total13 (7%)198 (16%)124719988 (5%)170 (15%)1168199710 (6%)173 (15%)1160199611 (6%)175 (14%)129419954 (2%)165 (18%)93619944 (3%)137 (15%) 8961993
CC diagnosedColonoscopiesin diarrhea
patients
Total colonoscopies
Year
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Prima del trattamento Dopo il trattamento
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Baert F et al GASTROENTEROLOGY 2002;122:20–25
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Prima Dopo
Baert F et al GASTROENTEROLOGY 2002;122:20–25
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Interventions for Treating CollagenousColitis: A Cochrane Inflammatory Bowel
Disease Group Systematic Review of Randomized Trials
Chande N et al Am J Gastroenterol 2004
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Am J Gastroenterol 2003
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CONCLUSIONI• Nelle coliti distali ha un’efficacia superiore
al placebo e agli steroidi tradizionali; efficacia analoga rispetto al 5-ASA
• Dati preliminari suggeriscono un ruolo nel trattamento della pouchite cronica refrattaria
• Possibile effetto sulla riduzione dell’output fecale nei pz. con M. di Crohn e portatori di ileostomia
• Farmaco efficace nel trattamento delle coliti collagene