title: Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents.
abstract: 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.
authors.affiliation: Department of Pediatrics, University of California, San Francisco, California 94143-0136, USA. mheyman@peds.ucsf.edu
authors.forename: Melvin B
authors.initials: MB
authors.lastname: Heyman
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Kierkus
authors.forename: Jean
authors.initials: J
authors.lastname: Spénard
authors.forename: Hadia
authors.initials: H
authors.lastname: Shbaklo
authors.forename: Monique
authors.initials: M
authors.lastname: Giguere
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects*; D011349:Proctitis / Q000188:drug therapy*; D013488:Suppositories; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013488:Suppositories; D019804:Mesalamine