Axel Dignass1, Robert Schnabel2, Jacek Romatowski3, Vladimir Pavlenko4, Andrey Dorofeyev5, Jelena Derova6, Laimas Jonaitis7, Karin Dilger8, Tanju Nacak9, Roland Greinwald9. 1. Department of Medicine 1, Agaplesion Markus Krankenhaus, Frankfurt am Main, Germany. 2. Pannónia Magánorvosi Centrum Kft, Budapest, Hungary. 3. Gastromed sc, Bialystok, Poland. 4. State Budgetary Educational Institution of Higher Professional Education, Stavropol, Russian Federation. 5. Regional Bowel Diseases Centre, Donetsk State Medical University, Donetsk, Ukraine. 6. Latvian Maritime Medical Centre, Riga, Latvia. 7. Department of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania. 8. Drug Safety, Dr Falk Pharma GmbH, Freiburg, Germany. 9. Clinical Research and Development Department, Dr Falk Pharma GmbH, Freiburg, Germany.
Abstract
BACKGROUND: Adherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis. OBJECTIVE: The objective of this study was to compare the efficacy, safety and preference of a novel high-dose 1000 mg mesalazine tablet versus conventional treatment for ulcerative colitis remission. METHODS: This pivotal phase III trial compared one 1000 mg mesalazine tablet (M1000 group) versus two registered 500 mg mesalazine tablets (M2x500 group), both taken three times daily, in patients with mild to moderately active ulcerative colitis. The primary efficacy variable was clinical remission at week 8. RESULTS: A total of 306 patients were considered for intent-to-treat analysis. Clinical remission was achieved in 45.0% of the patients in the M1000 group versus 41.9% in the M2x500 group (P < 0.001 for non-inferiority). Mucosal healing was achieved by 68.9% of the patients in the M1000 group and 68.4% in the M2x500 group. The majority of patients preferred the intake of one high-dose tablet (47.7%) over two low-dose tablets (10.5%). Oral treatment with high-dose 1000 mg mesalazine tablets was well tolerated without new safety signals. CONCLUSIONS: The novel high-dose 1000 mg mesalazine tablet is effective, non-inferior to the registered 500 mg mesalazine tablet, and safe for ulcerative colitis treatment. It was preferred by a majority of patients and may improve ulcerative colitis treatment adherence.
BACKGROUND: Adherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis. OBJECTIVE: The objective of this study was to compare the efficacy, safety and preference of a novel high-dose 1000 mg mesalazine tablet versus conventional treatment for ulcerative colitis remission. METHODS: This pivotal phase III trial compared one 1000 mg mesalazine tablet (M1000 group) versus two registered 500 mg mesalazine tablets (M2x500 group), both taken three times daily, in patients with mild to moderately active ulcerative colitis. The primary efficacy variable was clinical remission at week 8. RESULTS: A total of 306 patients were considered for intent-to-treat analysis. Clinical remission was achieved in 45.0% of the patients in the M1000 group versus 41.9% in the M2x500 group (P < 0.001 for non-inferiority). Mucosal healing was achieved by 68.9% of the patients in the M1000 group and 68.4% in the M2x500 group. The majority of patients preferred the intake of one high-dose tablet (47.7%) over two low-dose tablets (10.5%). Oral treatment with high-dose 1000 mg mesalazine tablets was well tolerated without new safety signals. CONCLUSIONS: The novel high-dose 1000 mg mesalazine tablet is effective, non-inferior to the registered 500 mg mesalazine tablet, and safe for ulcerative colitis treatment. It was preferred by a majority of patients and may improve ulcerative colitis treatment adherence.
Authors: Henrik Hjortswang; Gunnar Järnerot; Bengt Curman; Hanna Sandberg-Gertzén; Curt Tysk; Björn Blomberg; Sven Almer; Magnus Ström Journal: Scand J Gastroenterol Date: 2006-10 Impact factor: 2.423
Authors: B Flourié; H Hagège; G Tucat; D Maetz; X Hébuterne; J P Kuyvenhoven; T G Tan; M J Pierik; A A M Masclee; O Dewit; C S Probert; D Aoucheta Journal: Aliment Pharmacol Ther Date: 2013-03-04 Impact factor: 8.171
Authors: R Eliakim; Z Tulassay; L Kupcinskas; K Adamonis; J Pokrotnieks; S Bar-Meir; A Lavy; R Mueller; R Greinwald; I Chermesh; V Gross Journal: Aliment Pharmacol Ther Date: 2007-11-01 Impact factor: 8.171