Members of the International Salofalk Foam Study Group are listed in the Appendix.
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
Version of Record online: 20 AUG 2007
Alimentary Pharmacology & Therapeutics
Volume 26, Issue 9, pages 1237–1249, November 2007
How to Cite
ELIAKIM, R., TULASSAY, Z., KUPCINSKAS, L., ADAMONIS, K., POKROTNIEKS, J., BAR-MEIR, S., LAVY, A., MUELLER, R., GREINWALD, R., CHERMESH, I., GROSS, V. and ON BEHALF OF THE INTERNATIONAL SALOFALK FOAM STUDY GROUP (2007), 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. Alimentary Pharmacology & Therapeutics, 26: 1237–1249. doi: 10.1111/j.1365-2036.2007.03468.x
- Issue online: 22 AUG 2007
- Version of Record online: 20 AUG 2007
- Publication data Submitted 28 January 2007 First decision 21 February 2007 Resubmitted 5 August 2007 Accepted 16 August 2007
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.