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Mesalamine foam could replace liquid mesalamine enemas for ulcerative colitis

Last Updated: 2009-01-06 17:50:47 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In patients with proctitis and proctosigmoiditis, a mesalamine foam can be substituted for difficult-to-retain mesalamine liquid in therapeutic enemas.

In the December issue of the American Journal of Gastroenterology, an international team led by Dr. Antoine Cortot at Hopital Claude Huriez in Lille, France, points out that because mesalamine induces remission in ulcerative colitis, a placebo-controlled trial would have been unethical.

The researchers therefore conducted a noninferiority study, in which 375 patients were randomized to treatment with either mesalamine foam, 1 g/80 mL/d, or mesalamine liquid enema, 1 g/100 mL/d for 4 weeks. All patients had mild-to-moderate ulcerative colitis and disease extending at least 5 cm from the anorectal junction but not beyond the splenic flexure.

"Remission rates...in foam versus liquid were 68.3% versus 73.6% in per protocol population...and 66.7% versus 70.5% in intention-to-treat population," the researchers report. Both treatments were well tolerated, they add.

"Although the noninferiority of mesalamine foam could not be strictly demonstrated at week 4 in the per protocol analysis, it was achieved in the intention-to-treat population," the investigators write.

They add that because the trial had enrolled mostly proctitis and proctosigmoiditis patients, their results mainly concern these two forms of ulcerative colitis and it was not possible to reach conclusion for left-sided ulcerative colitis.

Nevertheless, they conclude, "Mesalamine foam enema represents a clinically efficient and well-tolerated therapeutic alternative to mesalamine liquid enemas in patients with mild-to-moderate active proctitis and proctosigmoiditis. It may be especially appropriate in case of poor tolerance of enemas because of acute rectal inflammation."

Am J Gastroenterol 2008;103:3106-3114.