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European Journal of Dermatology

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Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study Volume 17, numéro 3, May-June 2007

Auteurs
Institute for Skin Research, University Paris VII, Hôpital Saint-Louis, Paris, France, CDMTA Nicolae Kretzulescu, Bucharest, Romania, Clinical Hospital Colentina, Bucharest, Romania, Clinical Hospital Prof Scarlat Longhin, Bucharest, Romania, Centro Medico Vitae, Buenos Aires, Argentina, Hospital President Peron, Buenos Aires, Argentina, R+D Clinical Unit, J. Uriach y Compañía, S.A. Barcelona, Spain

This randomised, double-blind, placebo-controlled, parallel-group, international, dose-ranging study investigated the effect of treatment with rupatadine 5, 10 and 20 mg once daily for 4 weeks on symptoms and interference with daily activities and sleep in 12-65 years-old patients with moderate-to-severe chronic idiopathic urticaria (CIU). Rupatadine 10 and 20 mg significantly reduced pruritus severity by 62.05% and 71.87% respectively, from baseline, over a period of 4 weeks compared to reduction with placebo by 46.59% (p < 0.05). Linear trends were noted for reductions in mean number of wheals and interference with daily activities and sleep with rupatadine 10 and 20 mg over the 4-week treatment period. The two most frequently reported AEs were somnolence (2.90% for placebo, 4.29% for 5 mg-, 5.41% for 10 mg- and 21.43% for 20 mg-rupatadine-treated group) and headache (4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group). These findings suggest that rupatadine 10 and 20 mg is a fast-acting, efficacious and safe treatment for the management of patients with moderate-to-severe CIU. Rupatadine decreased pruritus severity, in a dose- and time-dependent manner.