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Real-World Use of Fexofenadine Parallels Clinical Trials: Presented at EAACI

By Jill Stein

PARIS, FRANCE -- June 13, 2003 -- Treating allergic-rhinitis with fexofenadine in the real-world clinical setting delivers results that are in line with those reported in clinical trials, researchers announced here June 10^th at the 22^nd Congress of the European Academy of Allergology and Clinical Immunology.

Claus Bachert, MD, PhD, from University Hospital of Ghent in Ghent, Belgium, presented findings from a post-marketing surveillance trial of fexofenadine that reviewed the clinical records of 13,007 patients with seasonal allergic rhinitis who were treated with the peripheral antihistamine fexofenadine.

Overall, 5% of the cohort had mild disease, 54% had moderate disease, and 36% had severe disease. Information about disease severity was not available in 5% of patients. The researchers assessed symptoms of nasal obstruction, eye complaints, nose itching, rhinorrhoea and sneezing.

Median time since the first occurrence of seasonal allergic rhinitis was 5 years, and mean treatment duration was 22 days.

Fexofenadine treatment was associated with a marked decrease in severity of all five symptoms (P</=0.001). The total symptom score for all five symptoms was reduced from 2.20 to 0.51 category classes on a 5-point scale where scores ranged from 0 to 4. A score of zero refers to a complete absence of symptoms, 1 refers to mild symptoms, 2 means that symptoms are distinct, 3 denotes severe symptoms, and 4 indicates that symptoms are very severe.

For 72.5% of patients, improvement was evident within 15 to 60 minutes after taking fexofenadine. Efficacy was rated as "very good" in 53% of cases, "good" in 38.09%, "satisfactory" in 3.81%, "sufficient" in 0.78%, and "insufficient" in 1.83% of cases.

Side effects of fexofenadine included fatigue in 0.15% of patients, headache in 0.07%, and nausea in 0.07%. Serious adverse events were observed in three patients, one of whom had skin swelling.

"The findings of this post-authorization survey in patients with seasonal allergic rhinitis demonstrate the good efficacy, tolerability, and safety of fexofenadine, and are in accordance with the results of clinical trials," Dr. Bachert said.

This trial was sponsored by Aventis Pharma, in Bad Soden, Germany.


[Study title: Fexofenadine In Clinical Practice: An Observation in 13000 Patients With Allergic Rhinitis. Abstract 984]

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