Vielen Dank für Ihre Beteiligung!
diese Info ist mir wohl bekannt. Meine Frage ging eher da hin, zu erfahren ob es aus dieser Studie schon erste Erkenntnisse gibt.
Mit besten Grüßen,
in der Hoffnung kein Placebo zu bekommen werde ich mich am Dienstag in Richtung Mainz aufmachen.
In der Not frisst der Teufel ja auch die Fliegen.
J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e363-9. doi: 10.1111/j.1468-3083.2012.04689.x. Epub 2012 Aug 29.
Randomized, double-blind, placebo-controlled study of safety and efficacy of miltefosine in antihistamine-resistant chronic spontaneous urticaria.
Magerl M1, Rother M, Bieber T, Biedermann T, Brasch J, Dominicus R, Hunzelmann N, Jakob T, Mahler V, Popp G, Schäkel K, Schlingensiepen R, Schmitt J, Siebenhaar F, Simon JC, Staubach P, Wedi B, Weidner C, Maurer M.
Chronic spontaneous urticaria (CSU), a mast cell-driven condition, is debilitating, common, and hard to treat. Miltefosine, a lipid raft modulator, can inhibit mast cell responses in vivo.
To study the safety and efficacy of systemic miltefosine treatment in CSU patients resistant to standard-dosed antihistamines.
In this investigator-initiated multicentre, randomized, double-blind, placebo-controlled study, CSU patients were treated for 4 weeks with daily doses of up to 150-mg miltefosine (n = 47) or placebo (n = 26). Disease activity was assessed using the urticaria activity score. Safety and tolerability of miltefosine were also assessed.
After 4 weeks of treatment, Urticaria Activity Score (UAS7) levels were substantially more reduced in miltefosine-treated patients (-6.3 vs. -3.5 in placebo-treated patients; P = 0.05). Also, the number of weals, but not the intensity of pruritus, was significantly reduced in miltefosine-treated patients vs. placebo-treated patients (P = 0.02). In general, adverse events were frequent in both groups (miltefosine: 88%, placebo: 65% of patients) but mostly mild to moderate in severity. We did not observe any serious adverse events.
The results of this study indicate that miltefosine is an effective and safe treatment option for CSU patients who do not respond to standard-dosed antihistamines.
Und ein weiteres Manuskript:
J Dermatolog Treat. 2013 Aug;24(4):244-9. doi: 10.3109/09546634.2012.671909. Epub 2012 Aug 5.
Miltefosine: a novel treatment option for mast cell-mediated diseases.
Maurer M1, Magerl M, Metz M, Weller K, Siebenhaar F.
Mast cell-mediated diseases such as urticaria, mastocytosis and atopic dermatitis are common, disabling and hard to treat. Recently, the lipid raft modulator miltefosine has been shown to inhibit mast cell activation in vitro and in vivo. Moreover, three randomized and placebo-controlled trials have assessed the effects of miltefosine in mast cell-driven conditions. Here, we review the experimental and clinical evidence in support of miltefosine as a novel treatment option for mast cell-mediated diseases and we discuss the most imminent questions and issues that need to be addressed by future research and clinical trials.