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Mesalazine not Superior to Placebo for IBS
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Mesalazine was not superior to placebo for treating symptoms of irritable bowel syndrome, according to new research data.
Aiming to evaluate the safety and efficacy of mesalazine in patients with IBS, researchers from Italy performed a double blind phase 3 trial involving 180 patients with IBS from 21 centers from February 2008 to March 2012. Participants were randomly assigned 800 mg mesalazine (n=88) or placebo (n=92) three times daily for 12 weeks, followed by an additional 12 weeks of follow-up.
Patients were considered primary endpoint responders if they reported weekly satisfactory relief of abdominal discomfort or pain at least 50% of the weeks in the treatment period, and were considered secondary endpoint responders if they reported weekly satisfactory relief of overall IBS symptoms at least 50% of the weeks. In explorative analyses, the 50% rule was changed to 75% or >75%. There was a comparable percentage of primary endpoint responders in each group, with 68.6% of the mesalazine group vs. 67.4% of the placebo group (P=.87). In the explorative analysis with the 75% rule, 43% of the mesalazine group vs. 31.4% of the placebo group were responders (P=.115), and with the >75% rule, 32.6% of the mesalazine group vs. 26.7% of the placebo group were responders (P=.404). For the secondary endpoint, 66.3% of the mesalazine group vs. 61.6% of the placebo group were responders (P=.525), with the 75% rule, 46.5% vs. 34.9% were responders (P=.121), and with the >75% rule, 38.4% vs. 23.3% were responders (P=.032). The safety profile of mesalazine was similar to that of placebo.
Although mesalazine was not superior than placebo based on the primary endpoint, data from the explorative analysis “indicate that a subgroup of patients with IBS responded better to mesalazine than placebo,” the researchers wrote. “The results of the present study indicate that a number of patients show a sustained therapy response and benefits from mesalazine therapy. Larger studies assessing the clinical predictors and confirming the beneficial effects of mesalazine are now required.”
Disclosure: See the study for a full list of researchers’ financial disclosures.
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