Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis
| Autor: | M Bátovský, Peter R. Gibson, J Tibitanzl, Roland Greinwald, Graham L. Radford-Smith, B Pekárková, B Fixa, Timothy H. Florin, L Gabalec |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Administration Oral Gastroenterology Inflammatory bowel disease Severity of Illness Index law.invention chemistry.chemical_compound Randomized controlled trial Mesalazine Double-Blind Method Polymethacrylic Acids law Sulfasalazine Internal medicine medicine Humans Pharmacology (medical) Antipyretic Cellulose Mesalamine Aged Olsalazine Aged 80 and over Hepatology business.industry Anti-Inflammatory Agents Non-Steroidal Middle Aged medicine.disease Ulcerative colitis Surgery Treatment Outcome Tolerability chemistry Colitis Ulcerative Female business medicine.drug Tablets |
| Zdroj: | Alimentary pharmacologytherapeutics. 23(7) |
| ISSN: | 0269-2813 |
| Popis: | Background There are no comparative studies of coated mesalazine.Aim To compare the efficacy and tolerability of Eudragit-L- and ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis.Methods A double-blind, double-dummy, randomized parallel group trial was performed across 18 centres in Australia, and 20 in Eastern Europe. Patients were treated with 3 g mesalazine for 8 weeks with the primary efficacy end point being clinical remission.Results Of 215 patients, 69% achieved clinical remission in both treatment groups (P < 0.001; chi-square test) with no differences in frequency of adverse events. In the Australian cohort (n = 63), the Eudragit-L group had a higher remission rate (73% vs. 36%) and responded 13 days faster, compared with those in the European group (67% vs. 84%, and 2 days respectively). No clear reasons for differences in treatment responses were identified.Conclusions Eudragit-L and ethylcellulose-coated mesalazine tablets are well tolerated and equally effective in achieving remission in mild-moderately active ulcerative colitis over 8 weeks. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
| Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |