Details

Autor(en) / Beteiligte

• Lochs, Herbert
• Mayer, Michael
• Fleig, Wolfgang E.
• Mortensen, Per Brobech
• Bauer, Peter
• Genser, Dieter
• Petritsch, Wolfgang
• Raithel, Martin
• Hoffmann, Rainer
• Gross, V.
• Plauth, Mathias
• Staun, Michael
• Nesje, Lars Birger

Titel

Prophylaxis of postoperative relapse in Crohn's disease with mesalamine: European cooperative Crohn's disease study VI

Ist Teil von

• Gastroenterology (New York, N.Y. 1943), 2000-02, Vol.118 (2), p.264-273

Ort / Verlag

New York, NY: Elsevier Inc

Erscheinungsjahr

2000

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Background & Aims: This study investigated if long-term treatment with high-dose mesalamine reduces the risk of clinical relapse of Crohn's disease after surgical resection. Methods: In a prospective, randomized, double-blind, multicenter study, 4 g of mesalamine (Pentasa; Ferring A/S, Vanløse, Denmark) daily was compared with placebo in 318 patients. Treatment was started within 10 days after resective surgery and continued for 18 months. Primary outcome parameter was clinical relapse as defined by an increase in Crohn's Disease Activity Index, reoperation, septic complication, or newly developed fistula. Risk factors for recurrence were prospectively defined to be analyzed in a stepwise proportional hazards model. Results: Cumulative relapse rates (±SE) after 18 months were 24.5% ± 3.6% and 31.4% ± 3.7% in the mesalamine (n = 152) and placebo (n = 166) groups, respectively ( P = 0.10, log-rank test, 1-sided). Retrospective analysis showed a significantly reduced relapse rate with mesalamine only in a subgroup of patients with isolated small bowel disease (n = 124; 21.8% ± 5.6% vs. 39.7% ± 6.1%; P = 0.02, log-rank test). Probability of relapse was predominantly influenced by the duration of disease ( P = 0.0006) and steroid intake before surgery (additional risk, P = 0.0003). Conclusions: Eighteen months of mesalamine, 4 g daily, did not significantly affect the postoperative course of Crohn's disease. Some relapse-preventing effect was found in patients with isolated small bowel disease. GASTROENTEROLOGY 2000;118:264-273