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Clinical trial: ulcerative colitis maintenance treatment with 5-ASA: a 1-year, randomized multicentre study comparing
C Prantera1, A Kohn, M Campieri
1Department of Gastroenterology, Azienda Osp. S. Camillo-Forlanini, Rome, Italy. prantera@tin.it
Alimentary Pharmacology & Therapeutics
|August 15, 2009
Summary
Once-daily 5-ASA-MMX offers comparable efficacy and safety to twice-daily Asacol for maintaining remission in ulcerative colitis patients. This study confirms 5-ASA-MMX as a convenient option for ulcerative colitis management.
Area of Science:
- Gastroenterology
- Clinical Pharmacology
Background:
- Ulcerative colitis (UC) management requires effective long-term therapies.
- 5-aminosalicylic acid (5-ASA) formulations are standard for UC treatment.
- 5-ASA-MMX is a novel 5-ASA formulation designed for once-daily dosing.
Purpose of the Study:
- To compare the efficacy and safety of 5-ASA-MMX (2.4 g/day, once daily) versus Asacol (2.4 g/day, twice daily) for maintaining remission in left-sided UC.
- To assess clinical and endoscopic remission rates after 12 months of treatment.
Main Methods:
- A double-blind, double-dummy, randomized, parallel-group study.
- 331 patients with UC in remission were randomized to receive either 5-ASA-MMX or Asacol for 12 months.
- Co-primary endpoints included clinical remission and combined clinical and endoscopic remission.
Main Results:
- No statistically significant differences were observed in clinical remission (68.0% vs. 65.9%) or combined clinical and endoscopic remission (60.9% vs. 61.7%) between 5-ASA-MMX and Asacol groups.
- Diary card data indicated statistically significant differences favoring 5-ASA-MMX.
- Both treatments demonstrated similar tolerability profiles.
Conclusions:
- Once-daily 5-ASA-MMX is as effective as twice-daily Asacol for maintenance treatment of ulcerative colitis.
- 5-ASA-MMX offers a comparable safety profile to Asacol.
- The once-daily dosing of 5-ASA-MMX provides a convenient alternative for UC maintenance therapy.
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