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

• Published in: Inflammatory bowel diseases 2005-05, Vol.11 (5), p.421-427
• Main Authors: Prantera, Cosimo, Viscido, Angelo, Biancone, Livia, Francavilla, Antonio, Giglio, Lucio, Campieri, Massimo
• Format: Article
• Language: English
• Subjects: 5‐aminosalicyclic acid; 5‐aminosalicyclic acid multi‐matrix; Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - pathology; Colon; Colonoscopy; Double-Blind Method; Drug Carriers; Enema; Female; Humans; Inflammatory bowel diseases; left‐sided ulcerative colitis; Male; mesalamine; Mesalamine - administration & dosage; Middle Aged; Patient Compliance; Remission; Tablets; Treatment Outcome; Ulcerative colitis
• ISSN: 1078-0998; 1536-4844
• DOI: 10.1097/01.MIB.0000158386.25660.1e

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.