Gastroenterology

Gastroenterology

Volume 116, Issue 2, February 1999, Pages 294-300
Gastroenterology

Alimentary Tract
Oral budesonide for prevention of postsurgical recurrence in Crohn's disease,☆☆

https://doi.org/10.1016/S0016-5085(99)70125-3Get rights and content

Abstract

Background & Aims: Prevention of postoperative recurrence after resection for Crohn's disease (CD) would be of great clinical benefit. The efficacy of oral budesonide for prevention of endoscopic recurrence was evaluated in patients undergoing resection for ileal or ileocecal CD. Methods: Sixty-three patients received budesonide and 66 received placebo in a double-blind, randomized trial with parallel groups. Ileocolonoscopy, including biopsy, was performed after 3 and 12 months. Indications for surgery were fibrostenosis (78 patients), disease activity (41), and other reasons (10). Results: The frequency of endoscopic recurrence did not differ between the groups at 3 and 12 months. In patients with disease activity as indication for surgery, the endoscopic recurrence rate at the anastomosis was lower in the budesonide group at 3 months, although not significantly (21% vs. 47%; P = 0.11), and at 12 months (32% vs. 65%; P = 0.047). There was no such difference with respect to fibrostenosis as indication for surgery. No differences in adverse event patterns were found between the two groups. Conclusions: Oral budesonide, 6 mg daily, offered no benefit in prevention of endoscopic recurrence after surgery for ileal/ileocecal fibrostenotic CD but decreased the recurrence rate in patients who had undergone surgery for disease activity.

GASTROENTEROLOGY 1999;116:294-300

Section snippets

Materials and methods

The study was a parallel-group, double-blind, placebo-controlled, multicenter study involving 13 centers in Belgium, Denmark, France, Germany, Italy, the Netherlands, the United Kingdom, and Sweden. The study was approved by the ethics committee at each participating center.

Patients

Of 134 patients recruited (February 1992 through August 1993), a total of 130 were randomized into the study. One patient never took any study drug and was omitted from all further analyses. Patient characteristics and disease history are shown in Table 3.

. Demography and disease history: All-patients-treated analysis

Empty CellBudesonide, 6 mg (n = 63)Placebo (n = 66)
Sex ratio (M/F)35/2827/39
Age (yr)a34 (20–76)36 (17–81)
Weight (kg)a64 (38–96)63 (39–83)
Previous resection (Y/N)19/4417/49
Time since resection

Discussion

Surgery for CD is most often performed because of complications such as abscess, fistula, and bowel obstruction or because of lack of response to medical treatment. However, disease recurrence is a major problem, and approximately 50% of patients required repeat surgery within 10 years.9 Endoscopic recurrence at the anastomosis has been shown to occur in a high percentage within a year after surgery.11, 12

Over the past years, different drugs have been investigated for recurrence prevention; no

Acknowledgements

The participation of the General Hospital, Birmingham, England; Herlev Hospital, Herlev, Denmark; Centre Hospitalier Lyon-Sud, Lyon, France; and Hospital Saint-Louis, Paris, France, in this study is gratefully acknowledged.

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  • Cited by (0)

    Address requests for reprints to: Robert Löfberg, M.D., Ph.D., Department of Gastroenterology, Huddinge University Hospital, SE-141 86 Huddinge, Sweden. Fax: (46) 8-585-82-335.

    ☆☆

    Supported by Astra Draco AB, Lund, Sweden.

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