Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis

Autor:	Xavier Hébuterne, D Maetz, T G Tan, Hervé Hagège, J P Kuyvenhoven, Gilbert Tucat, Marieke Pierik, Bernard Flourié, Chris Probert, Ad A.M. Masclee, D. Aoucheta, O. Dewit
Přispěvatelé:	Interne Geneeskunde, RS: NUTRIM - R2 - Gut-liver homeostasis
Jazyk:	angličtina
Rok vydání:	2013
Předmět:	Male Time Factors medicine.medical_treatment Severity of Illness Index Gastroenterology THERAPY law.invention chemistry.chemical_compound DOUBLE-BLIND Randomized controlled trial law Pharmacology (medical) Mesalamine Aged 80 and over MMX MESALAMINE ISSUES INDUCTION Anti-Inflammatory Agents Non-Steroidal Enema Middle Aged Ulcerative colitis Treatment Outcome Female Adult medicine.medical_specialty Adolescent 5-AMINOSALICYLIC ACID Drug Administration Schedule Young Adult Mesalazine Prolonged release Internal medicine Severity of illness medicine MANAGEMENT Humans Colitis Aged Hepatology business.industry REMISSION medicine.disease digestive system diseases Clinical trial MAINTENANCE chemistry Delayed-Action Preparations Colitis Ulcerative business INFLAMMATORY-BOWEL-DISEASE
Zdroj:	Alimentary Pharmacology & Therapeutics, 37(8), 767-775. Wiley
ISSN:	1365-2036 0269-2813
DOI:	10.1111/apt.12266
Popis:	BACKGROUND: Aminosalicylates are first-choice treatment for mild-to-moderately active ulcerative colitis (UC); however, multi-dosing regimens are inconvenient. AIM: To compare the efficacy and safety of once- (OD) vs. twice- (BD) daily prolonged-release mesalazine (Pentasa, Ferring, Saint-Prex, Switzerland) for active mild-to-moderate UC in a non-inferiority study. METHODS: Eligible patients (n = 206) were randomised to 8 weeks of mesalazine (4 g/day), either OD with two sachets of 2 g mesalazine granules in the morning (n = 102) or BD with one 2 g sachet in the morning and one in the evening (n = 104). Patients also received 4 weeks of mesalazine enema 1 g/day. Disease activity was assessed at randomisation, weeks 4, 8 and 12 using the UC Disease Activity Index (UC-DAI). Clinical and endoscopic remission (primary endpoint) was assessed after 8 weeks. Patients recorded stool frequency and rectal bleeding in a daily diary. RESULTS: The primary endpoint, non-inferiority in clinical and endoscopic remission with OD vs. BD mesalazine at 8 weeks, was met (intent-to-treat population: 52.1% vs. 41.8%, respectively, 95% confidence interval -3.4, 24.1; P = 0.14). Improvement of UC-DAI score (92% vs. 79%; P = 0.01) and mucosal healing (87.5% vs. 71.1%; P = 0.007) were significantly better, time to remission significantly shorter (26 vs. 28 days; P = 0.04) and safety similar with OD vs. BD dosing. CONCLUSIONS: When combined with mesalazine enema, prolonged-release mesalazine once-daily 4 g is as effective and well tolerated as 2 g twice-daily for inducing remission in patients with mild-to-moderately active ulcerative colitis (Clinicaltrials.gov: NCT00737789).
Databáze:	OpenAIRE
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