The researchers compared the efficacy and safety of a new foam enema (2 g mesalazine per day, Claversal Foam) with a standard liquid enema (4 g mesalazine per day, Salofalk enema) in patients with active distal UC.
The findings of the study were reported in the March issue of Alimentary Pharmacology and Therapeutics.
Patients with active distal UC, diagnosed according to standardized criteria, were treated for 4 weeks.
The primary goal was clinical remission. Endoscopic remission, histological changes, global assessment, and standard safety measures were also analyzed.
A major subset of the patients also provided quality-of-life data.
The team found that both foam and liquid enema gave good rates of clinical and endoscopic remission.
| Half as much of the active drug required in the foam enema.
| Alimentary Pharmacology and Therapeutics |
The foam enema was shown to be as efficacious as the reference. This was despite the fact that the daily dose in the foam treatment contained only half as much active drug as in the reference treatment.
Minor regional differences in efficacy were seen.
The tolerabilities of the two formulations were comparable.
Author H. Malchow, of the Klinikum Leverkusen, Germany, concluded on behalf of the group, "The foam enema offers a safe, efficacious, and acceptable treatment for distal UC."