Efficacy and Safety of Mesalamine 1 g HS Versus 500 mg BID Suppositories in Mild to Moderate Ulcerative Proctitis: A Multicenter Randomized Study

Abstract

This study showed that 1 g HS and 500 mg BID mesalamine suppository treatments of UP patients were equivalent in all facets of efficacy, safety, and compliance in a 6-week trial.

Adherence to Rectal Mesalamine in Patients with Ulcerative Colitis

“…23 A recent study has demonstrated that once-aday 5-ASA suppository has comparable efficacy (disease activity index), safety, and compliance (.95% in both groups) to a twicedaily 5-ASA suppositories in patients with ulcerative proctitis. 24 The patient-level interviews in this study provide insights into the barriers to adherence to rectal formulations as recommended in the development of patient-reported outcomes. 25 From our analyses, we found that issues with administration and intentional nonadherence were common themes in these interviews.…”

Discussion About Treatment of Ulcerative Colitis.

“…Novel delivery systems and higher dosing formulations of 5-ASA are also in development. These include the once-daily oral multimatrix (MMx) 5-ASA (SPD476) formulation [34,35] ; a twice-daily oral micropellet formulation [36] ; a once-daily, slow-release suppository formulation [37] ; and a 5-ASA rectal gel that treats the left colon and in early trials is preferred by patients over existing 5-ASA enema preparations. [38,39] A new MMx formulation of mesalamine (SPD476; MMX mesalamine) [40,41] is now undergoing clinical trials.…”

“…There was no difference in side effects and patients preferred twice-daily dosing. [36] A study by Lamet and colleagues [37] of 99 patients with ulcerative proctitis found that once-daily dosing of a 1-g extended-release mesalamine suppository was equivalent to a 500-mg twice-daily suppository for the induction of remission, with similar side effects. Finally, a 2-g gel formulation of rectal mesalamine provided similar efficacy to standard mesalamine foam enema for induction of remission at 4 weeks in mild-to-moderate left-sided ulcerative colitis with clinical, endoscopic, and histologic remission rates of 75%, 52%, and 30%, respectively.…”

Current approaches to the management of new-onset ulcerative colitis

“…Mesalamine suppositories or enemas may be effective in inducing remission for patients unresponsive to oral 5-ASAs or topical steroids particularly for patients with proctitis and distal symptoms 59. Mesalamine suppositories can be dosed at 500 mg twice daily or 1 g once daily; doses of 1 g administered nightly are considered optimal 1,60. The high efficacy and low side effect profile of rectal 5-ASA suppositories makes this formulation the treatment of choice for ulcerative proctitis 46.…”