Efficacy of desloratadine in intermittent allergic rhinitis: a GA 2 LEN study

Autor: Bousquet, J, Bachert, C, Canonica, G W, Mullol, J, Van Cauwenberge, P, Bindslev Jensen, C, Fokkens, W J, Ring, J, Keith, P, Lorber, R, Zuberbier, T, study group, ACCEPT-1
Přispěvatelé: AII - Amsterdam institute for Infection and Immunity, Ear, Nose and Throat
Rok vydání: 2009
Předmět:
Zdroj: Bousquet, J, Bachert, C, Canonica, G W, Mullol, J, Van Cauwenberge, P, Bindslev Jensen, C, Fokkens, W J, Ring, J, Keith, P, Lorber, R, Zuberbier, T & study group, ACCEPT 2009, ' Efficacy of desloratadine in intermittent allergic rhinitis: a GA(2)LEN study ', Allergy. European Journal of Allergy and Clinical Immunology, vol. 64, no. 10, pp. 1516-23 . https://doi.org/10.1111/j.1398-9995.2009.02115.x
Allergy, 64(10), 1516-1523. Wiley-Blackwell
ISSN: 1398-9995
0105-4538
Popis: Udgivelsesdato: 2009-Oct BACKGROUND: The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines proposed a classification for allergic rhinitis based on the duration of symptoms (intermittent, persistent) rather than on the time of allergen exposure (seasonal, perennial). There is no placebo-controlled, randomized clinical trial on intermittent allergic rhinitis (IAR) to date. Desloratadine (DL) is recommended for the first-line treatment of seasonal and perennial allergic rhinitis. OBJECTIVES: To assess the efficacy and safety of DL in subjects with IAR based on the ARIA classification. METHODS: Patients over 12 years of age with IAR were assessed over 15 days of treatment with DL 5 mg once daily (n = 276) or placebo (n = 271). The primary endpoint was the AM/PM reflective total 5 symptom score (T5SS). Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity by visual analogue scale, and quality-of-life. RESULTS: The mean reduction of AM/PM reflective T5SS was significantly greater with DL than with placebo over 15 days (-3.01 vs-2.13, P < 0.001) and on each individual day (P < 0.05). Mean AM instantaneous T5SS was reduced significantly with DL compared to placebo as early as day 2 (-1.84 vs-0.89; P < 0.001). The therapeutic response and improvement in quality-of-life were significantly greater with DL than with placebo (P < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (7.2%) and placebo (7.0%). CONCLUSIONS: This is the first large trial to show that treatment can be effective in IAR. Desloratadine was effective and safe.
Databáze: OpenAIRE