A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx

Cosimo Prantera, Angelo Viscido, Livia Biancone, Antonio Francavilla, Lucio Giglio, Massimo Campieri

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Multi-matrix (MMx), a new delivery system for mesalazine, seems to release 5-aminosalicyclic acid (5-ASA) preferentially in the sigmoid colon. This study had 2 objectives: (1) to evaluate the therapeutic response to MMx in patients with active left-sided disease and (2) to gain additional insights as to how the therapy would compare with topical 5-ASA. Methods: Patients received either 1.2 g of 5-ASA MMx three times per day plus placebo enema or 4 g of 5-ASA enema plus placebo tablets for 8 weeks. The primary endpoint was clinical remission (clinical activity index ≤4) at 8 weeks. Secondary endpoints were endoscopic and histologic remissions. Results: Seventy-nine patients were enrolled. Clinical remission rates at 4 and 8 weeks were 57.5% and 60.0% for patients treated with MMx and 68.4% and 50.0% for patients randomized to 5-ASA enemas, respectively (95% confidence interval for the difference at 8 weeks, - 12 to +32). Endoscopic remission was achieved by 45.0% of patients on 5-ASA MMx and by 36.8% of those on enema, whereas 15.0% and 8% of patients, respectively, showed histologic remission. Compliance was 97.0% for oral and 87.5% for topical therapy. In the enema group, compliance was 88.0% for the patients in remission and 65.5% for those with active disease. Conclusions: Preliminary studies suggest that similar rates for induction of remission can be expected from 5-ASA enemas and MMx for patients with left-sided ulcerative colitis.

Original languageEnglish
Pages (from-to)421-427
Number of pages7
JournalInflammatory Bowel Diseases
Volume11
Issue number5
DOIs
Publication statusPublished - May 2005

Keywords

  • 5-aminosalicyclic acid
  • 5-aminosalicyclic acid multi-matrix
  • Left-sided ulcerative colitis
  • Mesalamine

ASJC Scopus subject areas

  • Gastroenterology

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