Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Lochs, H; Mayer, M; Fleig, WE; Mortensen, PB; Bauer, P; Genser, D; Petritsch, W; Raithel, M; Hoffmann, R; Gross, V; Plauth, M; Staun, M; Nesje, LB.
Prophylaxis of postoperative relapse in Crohn's disease with mesalamine: European Cooperative Crohn's Disease Study VI.
Gastroenterology. 2000; 118(2):264-273
Doi: 10.1016/S0016-5085(00)70208-3
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Petritsch Wolfgang
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- Abstract:
- 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, 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
- Crohn Disease - prevention and control Crohn Disease - surgery
- Double-Blind Method -
- Double-Blind Method -
- Female -
- Follow-Up Studies -
- Humans -
- Male -
- Mesalamine - therapeutic use
- Middle Aged -
- Placebos -
- Proportional Hazards Models -
- Prospective Studies -
- Recurrence -
- Risk Factors -
- Time Factors -
- Treatment Outcome -