מתוך medicontext.co.il
LONDON (Reuters Health) – High dose balsalazide therapy is superior to low dose balsalazide or mesalazine treatment in preventing ulcerative colitis relapses, according to a report published in the December issue of Gut. Balsalazide was approved last year in the US for the treatment of mildly to moderately active ulcerative colitis.
Dr. W. Kruis, from the University of Cologne in Germany, and colleagues randomized 133 patients with ulcerative colitis in remission to receive 1.5 or 3.0 g of balsalazide twice daily or 0.5 g of mesalazine thrice daily. The patients were followed for 26 weeks.
The clinical remission rate in the high dose balsalazide group was 77.5%, significantly higher than the 43.8% and 56.8% rates in the low dose balsalazide and mesalazine groups, respectively (p = 0.006). Compared with the 1.5 g balsalazide group, the time to relapse was significantly longer in the 3.0 g balsalazide group (p = 0.005).
High dose balsalazide treatment was linked to better endoscopic scores than low dose treatment, the investigators note. However, scores with either balsalazide dose did not differ significantly from scores with mesalazine therapy.
Rates of treatment discontinuation and adverse events were similar in each group. In general, the side effects were mild, and all three regimens were well tolerated.
The current results contradict previous reports which have suggested that high dose balsalazide therapy provides little or no benefit over low dose therapy, the authors state.
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