More than 80% of Crohn's disease patients undergoing resection suffer recurrence of their disease.
Therapy with aminosalicylates, antimetabolites, or antibiotics leads to a modest reduction in the incidence of recurrence.
Dr Geert and colleagues from Belgium examined whether metronidazole for 3 months together with azathioprine for 12 months is superior to metronidazole alone to reduce recurrence of postoperative Crohn's disease in ‘high-risk’ patients.
The team found Crohn's disease patients undergoing curative ileocecal resection with 1 risk factor for recurrence received metronidazole, and azathioprine /placebo.
|Endoscopic recurrence in 55% in the azathioprine group|
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.
The researchers randomized 81 patients, however, 19 discontinued the study early.
Significant endoscopic recurrence was observed in 44% of patients in the azathioprine group, and in 69% patients in the placebo group at 12 months postsurgery.
Intention-to-treat analysis revealed endoscopic recurrence in 55% in the azathioprine group, and 78% in the placebo group at month 12.
At month 12, the team noted that 7 of 32 patients had no endoscopic lesions in the azathioprine group, versus 1 of 29 in the placebo group.
Dr Geert’s team concluded, “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 azathioprine 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 Crohn's disease patients with an enhanced risk for recurrence.”