Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis
| Autor: | Andrey E. Dorofeyev, Wolfgang Kruis, Marina Pesegova, Britta Siegmund, Konstantin Soloviev, Yuriy Mostovoy, Viacheslav Neshta, Yuriy Lozynskyy, Michael Vieth, Roland Greinwald, Pavel Andreev, Ralf Mohrbacher, Olga Alekseeva, Michael Stiess, Olena Levchenko, Sayar Abdulkhakov, Oleksii Datsenko |
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| Rok vydání: | 2017 |
| Předmět: |
Budesonide
Adult Male medicine.medical_specialty Adolescent Drug-Related Side Effects and Adverse Reactions Anti-Inflammatory Agents Suppository Gastroenterology law.invention Russia 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Mesalazine Randomized controlled trial Double-Blind Method law Internal medicine Multicenter trial medicine Humans Proctitis Prospective Studies Mesalamine Aged Hepatology business.industry Standard treatment Suppositories Middle Aged medicine.disease Ulcerative colitis Europe Treatment Outcome chemistry 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Colitis Ulcerative Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 17(1) |
| ISSN: | 1542-7714 |
| Popis: | Background & Aims Although proctitis is the most limited form of ulcerative colitis, it causes unpleasant symptoms. Topical mesalamine, the standard treatment, is not always effective. We conducted a randomized phase 2 trial to determine the efficacy and safety of 2 doses of a budesonide suppository vs mesalamine suppositories vs combined budesonide and mesalamine suppositories for proctitis. Methods We performed a prospective, double-blind, double-dummy, multicenter trial in 337 patients with active proctitis to compare the efficacies of 4 different suppository treatments. Patients were randomly assigned to groups given 2 mg budesonide suppositories (2 mg BUS; n = 89 patients), 4 mg BUS (n = 79), 1 g mesalamine suppositories (1 g MES; n = 81), or the combination of 2 mg BUS and 1 g MES (n = 88). The study was performed from November 2013 through July 2015 at 36 study sites in Europe and Russia. The primary end point was the time to resolution of clinical symptoms, defined as the first of 3 consecutive days with a score of 0 for rectal bleeding and stool frequency. Results The mean time to resolution of symptoms in the 4 mg BUS (29.8 days) and combination of 2 mg BUS and 1 g MES (29.3 days) groups resembled that of the standard 1 g MES treatment (29.2 days), but was significantly longer in the 2 mg BUS group (35.5 days). Furthermore, proportions of patients with deep, clinical, and endoscopic remission, as well as mucosal healing, were similar among the 1 g MES, 4 mg BUS, and combination therapy groups, but significantly lower in the group that received 2 mg BUS. No safety signals were observed, and the patients' treatment acceptance was high (67%–85% of patients). Conclusions In a multicenter randomized trial, we found that the efficacy and safety of 4 mg BUS in treatment of active proctitis did not differ significantly from those of 1 g MES. Budesonide suppositories offer an alternative therapy to mesalamine for topical treatment of proctitis. Clinicaltrialsregister.eu no: 2012-003362-41. |
| Databáze: | OpenAIRE |
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