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Farup, PG; Hinterleitner, TA; Lukas, M; Hebuterne, X; Rachmilewitz, D; Campieri, M; Meier, R; Keller, R; Rathbone, B; Oddsson, E.
Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis.
Inflamm Bowel Dis. 2001; 7(3):237-242 Doi: 10.1097%2F00054725-200108000-00009
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Co-Autor*innen der Med Uni Graz
Hinterleitner Thomas
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Abstract:
High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g. Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), 1 packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index: UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than -1 UC-DAI score unit. Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects. Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily dosing.
Find related publications in this database (using NLM MeSH Indexing)
Adolescent -
Adult -
Aged -
Anti-Inflammatory Agents, Non-Steroidal - administration and dosage
Colitis, Ulcerative - drug therapy
Delayed-Action Preparations - administration and dosage
Drug Administration Schedule - administration and dosage
Female - administration and dosage
Humans - administration and dosage
Male - administration and dosage
Mesalamine - administration and dosage
Middle Aged - administration and dosage
Severity of Illness Index - administration and dosage
Treatment Outcome - administration and dosage

Find related publications in this database (Keywords)
clinical trial
patient compliance
drug therapy
inflammatory bowel diseases
mesalazine
ulcerative colitis
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