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Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents.

Author(s): Heyman MB, Kierkus J, Spenard J, Shbaklo H, Giguere M

Affiliation(s): Department of Pediatrics, University of California, San Francisco, California 94143-0136, USA. mheyman@peds.ucsf.edu

Publication date & source: 2010-11, Inflamm Bowel Dis., 16(11):1931-9.

Publication type: Clinical Trial; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

BACKGROUND: Treatment of ulcerative proctitis has not been well studied in pediatric populations. We conducted an open-label trial to evaluate the clinical efficacy of a mesalamine suppository (500 mg) to treat pediatric patients with mild to moderate ulcerative proctitis. METHODS: Pediatric patients (5-17 years of age) with ulcerative proctitis were enrolled for baseline evaluations, including a flexible sigmoidoscopic (or colonoscopic) assessment with biopsies performed at study entry. Eligible patients were started on mesalamine suppositories (500 mg) at bedtime. Two follow-up visits were scheduled after 3 and 6 weeks of treatment. The dose could be increased to 500 mg twice daily at the week 3 follow-up visit if deemed appropriate by the investigator based on the Disease Activity Index (DAI) assessment. The primary outcome measure was a DAI derived from a composite score of stool frequency, urgency of defecation, rectal bleeding, and general well-being. RESULTS: Forty-nine patients were included in the intent-to-treat analysis. The mean DAI value decreased from 5.5 at baseline to 1.6 and 1.5 at weeks 3 and 6, respectively (P < 0.0001). Only 4 patients had their dose increased to 500 mg twice daily at week 3. Forty-one patients experienced at least one adverse event, most of which were deemed mild and unrelated to study therapy. The most common treatment-emergent adverse events were gastrointestinal (n = 30, 61.2%). CONCLUSIONS: This study showed that a daily bedtime dose of a 500 mg mesalamine suppository is safe and efficacious in children with ulcerative proctitis.

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