SAFETY AND EFFICACY OF CONTROLLED-RELEASE MESALAMINE FOR MAINTENANCE OF REMISSION IN ULCERATIVE-COLITIS

This 12 month, double-blind, placebo-controlled study randomized 205 u lcerative colitis patients in remission to placebo or controlled-relea se mesalamine at 4 g/day for 12 months. Patients were stratified to ei ther pancolitis or left-sided disease, based on previous diagnosis. Ma intenance of remission was defined as a sigmoidoscopic index of <5, le ss than five stools per day, and the absence of rectal bleeding. A sig nificantly greater number of patients maintained remission on mesalami ne 4 g/day than on placebo at each of five study,visits, following the first one-month visit (P < 0.05). The estimated 12-month remission ra tes for the mesalamine group were 64% (38% for placebo, P = 0.0004). B aseline subgroups (disease location, time since last flare of active d isease, and previous response to oral/rectal steroids or sulfasalazine ) did not influence remission rates. Treatment-related adverse events were rare. Controlled-release mesalamine is a safe and efficacious sin gle agent for maintaining remission of ulcerative colitis.