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Fexofenadine (Allegra) Safe and Efficacious in Children With Seasonal Allergic Rhinitis: Presented at AAAAI
By Bonnie Darves
SAN FRANCISCO, CA -- March 24, 2004 -- The antihistamine fexofenadine (Allegra), appears to be both safe and effective in the treatment of seasonal allergic rhinitis (SAR) in young children age 6 through 11, according to results of a large study presented here at the American Academy of Allergy, Asthma & Immunology Annual meeting.
"[Fexofenadine] was effective in reducing the symptoms in this population -- and it was safe and well tolerated," said study co-author Allan Puterman, MD, University of Cape Town, South Africa. He added that although the drug has not yet been approved for use in this population in the United States, because little safety data has been available, it has now been registered in South Africa and other countries.
The placebo-controlled, double blind study of 579 children, conducted in 40 centres in the Southern Hemisphere, involved 303 patients with a 1-year history of SAR, predominantly from grass allergy (>93%). Following positive skin-prick test results, patients were randomised to receive either 30 mg BID of fexofenadine or placebo for 2 weeks. They were evaluated for efficacy based on change in 12-hour total symptom scores from baseline.
Fexofenadine treatment significantly improved total symptom scores compared to placebo (P = .0178) and was well tolerated. Dr. Puterman said that the Southern Hemisphere study, as well as a similar European study, used the same efficacy end points employed in previous adult trials and generated similar safety profiles, further validating the use of fexofenadine in children.
"The drug is now approved for this younger population in Europe and South Africa, and it's likely the U.S. will follow," Dr. Puterman said.
[Study Title: Pollen Aeroallergen Sensitization and Efficacy of Fexofenadine in Children From the Southern Hemisphere. Poster 826]
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