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, of 5-ASA enema Plus placebo tablets for 8 weeks. The primary endpoint was clinical remission (clinical activity index &LE; 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.
Prantera C., V.A. (2005). A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx. INFLAMMATORY BOWEL DISEASES, 11(5), 421-427.
|Tipologia:||Articolo su rivista|
|Citazione:||Prantera C., V.A. (2005). A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx. INFLAMMATORY BOWEL DISEASES, 11(5), 421-427.|
|Settore Scientifico Disciplinare:||Settore MED/12 - Gastroenterologia|
|Revisione (peer review):||Sì, ma tipo non specificato|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1097/01.MIB.0000158386.25660.1e|
|Stato di pubblicazione:||Pubblicato|
|Data di pubblicazione:||2005|
|Titolo:||A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx|
|Autori:||Prantera C., Viscido A., Biancone L., Francavilla A., Giglio L., Campieri M.|
|Appare nelle tipologie:||01 - Articolo su rivista|