Once or Twice Daily Mesalazine for Ulcerative Colitis
Author Information
Author(s): Kamm M A, Lichtenstein G R, Sandborn W J, Schreiber S, Lees K, Barrett K, Joseph R
Primary Institution: St Vincent’s Hospital, Melbourne, Australia
Hypothesis
This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.
Conclusion
MMX mesalazine 2.4 g/day administered as a single or divided dose demonstrated a good safety profile, was well tolerated, and was effective as maintenance treatment.
Supporting Evidence
- 174 patients experienced 384 adverse events, mostly mild or moderate.
- At month 12, 64.4% of patients in the once-daily group and 68.5% in the twice-daily group were in clinical and endoscopic remission.
- 88.9% of patients in the once-daily group and 93.2% in the twice-daily group maintained clinical remission.
Takeaway
This study looked at a medicine called MMX mesalazine to help people with a tummy problem called ulcerative colitis. It found that taking it once a day or twice a day worked well and was safe.
Methodology
This multicentre, randomised, open-label trial enrolled patients with clinical and endoscopic remission, randomising them to MMX mesalazine 2.4 g/day as a single or divided dose for 12 months.
Potential Biases
Potential bias due to the lack of a placebo group and the open-label design.
Limitations
The study did not include a placebo arm, and the sample size was dependent on the number of patients in remission at the end of the parent studies.
Participant Demographics
Patients included both males and females with a mean age of approximately 42 years, predominantly Caucasian.
Statistical Information
P-Value
0.351
Confidence Interval
95% CI 0.56 to 1.23
Statistical Significance
p=0.351
Digital Object Identifier (DOI)
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