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Gastroenterologie
a hepatologie

Gastroenterology and Hepatology

Gastroent Hepatol 2018; 72(4): 329–333. doi:10.14735/amgh2018329.

The efficacy and safety of budesonide MMX (Cortiment®) for long-term maintenance therapy of ulcerative colitis

Luděk Hrdlička Orcid.org  1,2, Martin Bortlík Orcid.org  3,4,5, Tomáš Douda Orcid.org  6, Pavel Drastich Orcid.org  7, Přemysl Falt Orcid.org  8, Petra Matějková Orcid.org  9,10, Pavla Koželuhová Orcid.org  11, Martin Liberda Orcid.org  12, Lenka Nedbalová13, Aleš Novotný Orcid.org  14, Martin Kolář3, Milan Lukáš Orcid.org  3

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Summary

Background: The role of budesonide-MMX (Cortiment®) in the induction of remission in mild to moderate active ulcerative colitis (UC) is already well established; however, data on maintenance treatment are limited. Aim: To assess the efficacy and safety of this medication as a long-term maintenance treatment. Methods: Forty patients, corresponding to responders in a previous 8-weeks induction study on continuing medication, were included in this multicentric (10 Czech centers were involved) retrospective 12-month study. Partial Mayo score and endoscopic Mayo score were assessed at 6 and 12 months, adverse events of special interest were recorded, and tolerability and compliance data were collected. Results: Significant maintenance of decreased clinical and endoscopic activity of UC were observed; the mean partial resp. endoscopic Mayo scores were 2.2 resp. 0.96 at week 8, 2.33 resp. 1.09 at 6 months, and 1.03 resp. 0.86 at 12 months. Complete mucosal healing (Mayo 0) was found in 19 (48%) patients at month 12. Clinical remission was achieved in 63% resp. (month 6) 66% (month 12) patients. A clinical response was observed even in 80% resp. 85% patients. The incidence of adverse events (AE) was very low. No patient interrupted or discontinued the maintenance medication because of the risk of experiencing AE. Conclusion: Our results demonstrate good efficacy and safety of Cortiment® use in the long-term maintenance treatment of mild to moderate UC.

Keywords

budesonide-MMX, glukocorticoids, maintenance therapy, ulcerative colitis

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