Browsing by Author "Stolte, M."

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    Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis
    (2006-01) Gross, V.; Bar-Meir, S.; Lavy, A.; Mickisch, O.; Tulassay, Z.; Pronai, L.; Kupcinskas, L.; Kiudelis, G.; Pokrotnieks, J.; Kovács, Á; Faszczyk, M.; Razbadauskas, A.; Margus, B.; Stolte, M.; Müller, R.; Greinwald, R.
    Background: Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis. Aim: To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema. Methods: Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index >4 and endoscopic index ≥4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index ≤4) at the final/withdrawal visit (per protocol). Results: A total of 541 patients were randomized - 533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%). Conclusion: Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.
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    Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine
    (2004-11) Kruis, W.; Frič, P.; Pokrotnieks, J.; Lukáš, M.; Fixa, B.; Kaščák, M.; Kamm, M. A.; Weismueller, J.; Beglinger, C.; Stolte, M.; Wolff, C.; Schulze, J.
    Background and aim: Evidence exists for the pathogenic role of the enteric flora in inflammatory bowel disease. Probiotics contain living microorganisms which exert health effects on the host. We compared the efficacy in maintaining remission of the probiotic preparation Escherichia coli Nissle 1917 and established therapy with mesalozine in patients with ulcerative colitis. Patients and methods: In total, 327 patients were recruited and assigned to a double blind, double dummy trial to receive either the probiotic drug 200 mg once daily (n = 162) or mesalozine 500 mg three times daily (n = 165). The study lasted for 12 months and patients were assessed by clinical and endoscopic activity indices (Rochmilewitz) as well as by histology. The primary aim of the study was to confirm equivalent efficacy of the two drugs in the prevention of relapses. Results: The per protocol analysis revealed relapses in 40/110 (36.4%) patients in the E coli Nissle 1917 group and 38/112 (33.9%) in the mesalazine group (significant equivalence p = 0.003). Subgroup analyses showed no differences between the treatment groups in terms of duration and localisation of disease or pretrial treatment. Safety profile and tolerability were very good for both groups and were not different. Conclusions: The probiotic drug E coli Nissle 1917 shows efficacy and safety in maintaining remission equivalent to the gold standard mesalazine in patients with ulcerative colitis. The effectiveness of probiotic treatment further underlines the pathogenetic significance of the enteric flora.