Document Detail

Therapy of metronidazole with azathioprine to prevent postoperative recurrence of Crohn's disease: a controlled randomized trial.
MedLine Citation:
PMID:  18727929     Owner:  NLM     Status:  MEDLINE    
BACKGROUND & AIMS: More than 80% of Crohn's disease (CD) patients undergoing resection suffer recurrence of their disease. Therapy with aminosalicylates, antimetabolites, or antibiotics leads to a modest reduction in the incidence of recurrence.
GOAL: We sought to examine whether metronidazole for 3 months together with azathioprine (AZA) for 12 months is superior to metronidazole alone to reduce recurrence of postoperative CD in "high-risk" patients.
METHODS: CD patients undergoing curative ileocecal resection with >or=1 risk factor for recurrence received metronidazole (3 months) and AZA/placebo (12 months). The primary end point was the proportion of patients with significant endoscopic recurrence 3 and 12 months after surgery. Secondary end points included clinical recurrence, safety, and tolerability of treatment.
RESULTS: Eighty-one patients were randomized; 19 discontinued the study early. Significant endoscopic recurrence was observed in 14 of 32 (43.7%) patients in the AZA group and in 20 of 29 (69.0%) patients in the placebo group at 12 months postsurgery (P = .048). Intention-to-treat analysis revealed endoscopic recurrence in 22 of 40 (55%) in the AZA group and 32 of 41 (78%) in the placebo group at month 12 (P = .035). At month 12, 7 of 32 patients had no endoscopic lesions in the AZA group, versus 1 of 29 in the placebo group (P = .037).
CONCLUSIONS: Despite the enhanced risk of recurrence, the overall incidence of significant recurrence was rather low, probably owing to the metronidazole treatment that all patients received. Concomitant AZA resulted in lower endoscopic recurrence rates and less severe recurrences 12 months postsurgery, predicting a more favorable clinical outcome. This combined treatment seems to be recommendable to all operated CD patients with an enhanced risk for recurrence.
Geert R D'Haens; Severine Vermeire; Gert Van Assche; Maja Noman; Isolde Aerden; Gust Van Olmen; Paul Rutgeerts
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-07-16
Journal Detail:
Title:  Gastroenterology     Volume:  135     ISSN:  1528-0012     ISO Abbreviation:  Gastroenterology     Publication Date:  2008 Oct 
Date Detail:
Created Date:  2008-10-20     Completed Date:  2008-11-14     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1123-9     Citation Subset:  AIM; IM    
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MeSH Terms
Anti-Infective Agents / administration & dosage*,  adverse effects
Azathioprine / administration & dosage*,  adverse effects
Combined Modality Therapy
Crohn Disease / drug therapy*,  epidemiology,  surgery*
Drug Therapy, Combination
Immunosuppressive Agents / administration & dosage*,  adverse effects
Metronidazole / administration & dosage*,  adverse effects
Middle Aged
Patient Dropouts
Postoperative Complications / epidemiology,  prevention & control
Recurrence / prevention & control
Risk Factors
Treatment Outcome
Reg. No./Substance:
0/Anti-Infective Agents; 0/Immunosuppressive Agents; 140QMO216E/Metronidazole; MRK240IY2L/Azathioprine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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