Clinical trial: Randomized-controlled clinical study comparing the efficacy and safety of a low-volume vs. a high-volume mesalazine foam in active distal ulcerative colitis

R. Eliakim, Z. Tulassay, L. Kupcinskas, K. Adamonis, J. Pokrotnieks, S. Bar-Meir, A. Lavy, R. Mueller, R. Greinwald, I. Chermesh, V. Gross

Research output: Contribution to journalArticlepeer-review

33 Citations (Scopus)
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Abstract

Background: Rectally administered mesalazine (mesalamine; 5-aminosalicylic acid) is the first-line therapy for treatment of distal ulcerative colitis. Recently, a high-volume 5-aminosalicylic acid foam has been shown to be as effective and safe as standard 5-aminosalicylic acid enema. Aim: To study the efficacy and safety of a low-volume vs. a high-volume 5-aminosalicylic acid foam. Methods: In this investigator-blinded study, patients with active distal ulcerative colitis [Clinical Activity Index (CAI) > 4, Endoscopic Index ≥ 4] were randomized to receive 2 × 1 g/30 mL low-volume (n = 163) or 2 × 1 g/60 mL high-volume 5-aminosalicylic acid foam (n = 167) for 42 days. Primary end point was clinical remission (CAI ≤ 4) at the final/withdrawal visit (per-protocol). Results: 330 patients were evaluable for efficacy and safety by intention-to-treat, 290 for per-protocol analysis. Clinical remission rates at week 6 (per-protocol) were 77% on low-volume foam vs. 77% on high-volume foam (P = 0.00002 for non-inferiority). The low-volume foam was associated with a lower frequency of severe discomfort, pain and retention problems. Conclusions: Low-volume 5-aminosalicylic acid foam is as effective and safe as a high-volume 5-aminosalicylic acid foam in the treatment of active distal ulcerative colitis, but offers compliance advantages compared to the high-volume preparation.

Original languageEnglish
Pages (from-to)1237-1249
Number of pages13
JournalAlimentary Pharmacology and Therapeutics
Volume26
Issue number9
DOIs
Publication statusPublished - Nov 2007
Externally publishedYes

Field of Science*

  • 3.1 Basic medicine
  • 3.2 Clinical medicine

Publication Type*

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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