Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Hawkey, CJ; Dube, LM; Rountree, LV; Linnen, PJ; Lancaster, JF.
A trial of zileuton versus mesalazine or placebo in the maintenance of remission of ulcerative colitis. The European Zileuton Study Group For Ulcerative Colitis.
Gastroenterology. 1997; 112(3):718-724
Doi: 10.1053/gast.1997.v112.pm9041232
Web of Science
PubMed
FullText
FullText_MUG
- Co-Autor*innen der Med Uni Graz
- Krejs Günter Josef
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- BACKGROUND & AIMS: Leukotriene B4 is a major neutrophil chemoattractant detected during relapse of inflammatory bowel disease and represents a potentional therapeutic target. The aim of this study was to compare the efficacy of zileuton, an active 5-lipoxygenase inhibitor, with mesalazine and placebo in the maintenance of remission in ulcerative colitis. METHODS: A double-blind, parallel-group, multicenter, and multinational trial was conducted during a 6-month period in hospital-based patients with inflammatory bowel disease. Three hundred five evaluable patients with ulcerative colitis in remission at the start of the trial were randomized into groups to undergo oral treatment with zileuton (600 mg qid; n = 113), mesalazine (400 mg qid; n = 99), or placebo (n = 111). The primary efficacy outcome was maintenance of remission for 6 months. A multivariate analysis was used to investigate determinants of relapse. Safety was assessed by treatment discontinuation, adverse events, vital signs, and laboratory parameters. RESULTS: After 6 months, 54% of patients receiving zileuton remained in remission compared with 43% receiving placebo (P = 0.094) and 63% on mesalazine (P = 0.266). Relapse rates on mesalazine were significantly lower than those for placebo (P = 0.017). All treatments were well tolerated. CONCLUSIONS: Zileuton (600 mg qid) was not significantly better than placebo in the maintenance of remission of ulcerative colitis in this trial and may have limited potential in the treatment of this condition.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Aminosalicylic Acids - adverse effects
- Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
- Colitis, Ulcerative - drug therapy
- Double-Blind Method - drug therapy
- Female - drug therapy
- Humans - drug therapy
- Hydroxyurea - adverse effects
- Lipoxygenase Inhibitors - therapeutic use
- Male - therapeutic use
- Mesalamine - therapeutic use
- Middle Aged - therapeutic use
- Multivariate Analysis - therapeutic use