Desloratadine Effectively Relieves Morning Symptom

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Introduction: Symptoms of SAR associated with grass, weed, and tree pollen occur in early to mid-spring through late summer to early autumn, and those associated with outdoor mold spores mainly occur from summer to early autumn. Outdoor allergies were the most common, reported by 80% of the respondents. (Binder E, Holopainen E, Malmberg H, et al. Anamnestic data in allergic rhinitis. Allergy. 1982;37:389-396). • SAR precipitates nasal symptoms such as sneezing, nasal itching, rhinorrhea, and nasal congestion, as well as non-nasal symptoms such as itching of the ears and palate and itching, tearing, burning, and redness of the eyes. (The Allergy Report. American Academy of Allergy, Asthma & Immunology, Inc. 2000. Available at: www.aaaai.org/ar. Accessed April 17, 2006. Skoner DP. Allergic rhinitis: Definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol. 2001;108(1 suppl):S2-S8. Pleskow W, Grubbe R, Weiss S, et al. Efficacy and safety of an extended-release formulation of desloratadine and pseudoephedrine vs the individual components in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2005;94:348-354. Desloratadine Effectively Relieves Morning Symptoms of Seasonal Allergic Rhinitis C Neukirch, MD1, P Devillier, MD, PhD2, I Dreyfus, PharmD 3 1Hôpital Bichat, Paris, France; 2Hôpital Foch, Suresnes, France; 3Schering-Plough, Levallois Perret, France

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Background: The ability of desloratadine to relieve morning symptoms of seasonal allergic rhinitis (SAR) was assessed in a double-blind, placebo-controlled, phase 4 study in France. Objetive: To assess the efficacy of desloratadine in relieving AM symptoms in patients with SAR.

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Methods: • This was a double-blind, placebo-controlled, multicenter study conducted at 102 centers in France between April and October 2002. • Men and women ≥18 years of age with SAR, in general good health, and without any other clinically significant disease were enrolled in the study. Women of childbearing potential had to be using or agree to use an acceptable method of contraception; pregnant or nursing women were excluded. Inclusion criteria: ≥2-year history of recurrent SAR caused by grass pollen • Diagnosis confirmed with positive skin-prick test (mean diameter of induration ≥3 mm and >50% of positive control) within 24 months before screening visit (Visit 1; Day -7 to -1), or performed at screening visit • Clinical symptoms of SAR present at baseline and start of treatment (Visit 2; Day 0), with total symptom score ≥8, nasal congestion score ≥2, and non-nasal symptom score ≥2

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TNSS=Puntaje total de sintomas nasales TNNSS=Puntaje total de sintomas no nasales TSSS= Puntaje total de sintomas de RAE Resultados

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Resultados

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Conclusiones • Desloratadina 5mg una vez al dia mejora significativamente los sintomas matutinos nasales y no nasales en pacientes con RAE sobre el periodo de 15 dias de estudio comparado con placebo. Diferencias significativas fueron observadas desde el segundo dia. • Los pacientes tratados con Desloratadina experimentan un porcentaje significativo de dias sin sintomas de RAE en la mañana comparado con aquellos que recibieron placebo. • Desloratadina fue bien tolerada, con un perfil de eventos adversos similares a placebo. • Los resultados de este analisis demostraron que desloratadina provee un efectivo y sostenido alivio de los sintomas AM de la RAE.