Browsing by Author "Kupcinskas, L."

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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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    Clinical trial : Randomized-controlled clinical study comparing the efficacy and safety of a low-volume vs. a high-volume mesalazine foam in active distal ulcerative colitis
    (2007-11) Eliakim, R.; Tulassay, Z.; Kupcinskas, L.; Adamonis, K.; Pokrotnieks, J.; Bar-Meir, S.; Lavy, A.; Mueller, R.; Greinwald, R.; Chermesh, I.; Gross, V.
    Background: Rectally administered mesalazine (mesalamine; 5-aminosalicylic acid) is the first-line therapy for treatment of distal ulcerative colitis. Recently, a high-volume 5-aminosalicylic acid foam has been shown to be as effective and safe as standard 5-aminosalicylic acid enema. Aim: To study the efficacy and safety of a low-volume vs. a high-volume 5-aminosalicylic acid foam. Methods: In this investigator-blinded study, patients with active distal ulcerative colitis [Clinical Activity Index (CAI) > 4, Endoscopic Index ≥ 4] were randomized to receive 2 × 1 g/30 mL low-volume (n = 163) or 2 × 1 g/60 mL high-volume 5-aminosalicylic acid foam (n = 167) for 42 days. Primary end point was clinical remission (CAI ≤ 4) at the final/withdrawal visit (per-protocol). Results: 330 patients were evaluable for efficacy and safety by intention-to-treat, 290 for per-protocol analysis. Clinical remission rates at week 6 (per-protocol) were 77% on low-volume foam vs. 77% on high-volume foam (P = 0.00002 for non-inferiority). The low-volume foam was associated with a lower frequency of severe discomfort, pain and retention problems. Conclusions: Low-volume 5-aminosalicylic acid foam is as effective and safe as a high-volume 5-aminosalicylic acid foam in the treatment of active distal ulcerative colitis, but offers compliance advantages compared to the high-volume preparation.