title: Prophylaxis of postoperative relapse in Crohn's disease with mesalamine: European Cooperative Crohn's Disease Study VI.
abstract: OBJECTIVE
  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, Vanlose, 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.
authors.affiliation: IV Medizinische Klinik, Universitätsklinikum Charité, Humboldt Universität, Berlin, Germany. herbet.lochs@charite.de
authors.forename: H
authors.initials: H
authors.lastname: Lochs
authors.forename: M
authors.initials: M
authors.lastname: Mayer
authors.forename: W E
authors.initials: WE
authors.lastname: Fleig
authors.forename: P B
authors.initials: PB
authors.lastname: Mortensen
authors.forename: P
authors.initials: P
authors.lastname: Bauer
authors.forename: D
authors.initials: D
authors.lastname: Genser
authors.forename: W
authors.initials: W
authors.lastname: Petritsch
authors.forename: M
authors.initials: M
authors.lastname: Raithel
authors.forename: R
authors.initials: R
authors.lastname: Hoffmann
authors.forename: V
authors.initials: V
authors.lastname: Gross
authors.forename: M
authors.initials: M
authors.lastname: Plauth
authors.forename: M
authors.initials: M
authors.lastname: Staun
authors.forename: L B
authors.initials: LB
authors.lastname: Nesje
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003424:Crohn Disease / Q000517:prevention & control* / Q000601:surgery*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D019804:Mesalamine