Keywords
glukocorticoids
ulcerative colitis
Abstract
Background: Budesonide MMX (Cortiment® 9 mg) is a novel local-acting glucocorticoid for the treatment of mild-to-moderate active ulcerative colitis (UC). Aim: To assess the efficacy and safety of this treatment in UC patients. Methods: In 81 patients (ten centers in the Czech Republic were involved) with mild-to-moderate UC, treatment with Cortiment® 9 mg once daily was initiated according to routine clinical practice. These patients were included in an 8 week retrospective multicenter study. The partial Mayo score and endoscopic Mayo score were assessed at weeks 0, 4 and 8, resp. 0 and 8. Adverse events of special interest, as well as tolerability and compliance data, were collected at weeks 4 and 8. Results: The clinical and endoscopic activity of UC was significantly decreased; the mean partial resp. endoscopic Mayo score decreased from 5.46, resp. 2.09 at week 0 to 1.99, resp. 1.02 at week 8. Complete mucosal healing (Mayo 0) was observed in 22 (29.3%) patients at week 8. Clinical remission was achieved in 14% (week 4) and 52% (week 8) of patients. A clinical response was observed in 70% (week 4) and 84% (week 8) of patients. The safety profile was excellent: the incidence of each adverse event did not exceed 5%, an adverse event was reported by 13 patients (16%), and only four patients (4.9%) discontinued the medication because they experienced an adverse event. Conclusion: Our results demonstrated the very good efficacy and excellent safety profile of Cortiment® 9 mg in the treatment of UC.References
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