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| |  AAAAI: Once-Daily Fexofenadine 180 mg (Allegra) Effectively Treats Chronic Idiopathic Urticaria By Bruce Sylvester SAN ANTONIO, TX -- March 21, 2005 -- Once-daily treatment with fexofenadine (Allegra) offers effective relief from chronic idiopathic urticaria (CIU), researchers reported here on March 20th at the 61st annual meeting of the American Academy of Allergy, Asthma and Immunology. Over the 28-day study, patients on 180-mg once-daily fexofenadine did significantly better over weeks 1, 2, 3 and 4, and also on overall scores in comparison to placebo, said investigator Santosh Varghese, MD, director of allergy, asthma and anti-infective research, Aventis Pharmaceuticals. "The implication for the patient is that now they have a safe and effective product that they can take once a day for the treatment of CIU," Dr. Varghese said. Although fexofenadine is approved for treatment of CIU at a dose of 60 mg twice daily, Dr. Varghese said his team tested a once-daily dose to see if a more convenient formulation would work for subjects. The investigators enrolled subjects age 12 years and older who had received a diagnosis of CIU and who showed signs and symptoms of active disease. The study was randomized, double-blind, parallel-group and placebo-controlled. After a placebo run-in phase of 2-5 days, the researchers randomized 255 symptomatic patients to either fexofenadine 180 mg (n= 163) or placebo (n =92) once daily for 28 days. Total symptom scores included the sum of whealscore (0=0 wheals to 3>20 wheals) and severity of pruritus score (0=no pruritus to 4=very severe). Primary endpoints included 12-hour AM and PM reflective total symptom scores and mean total symptoms scores (mean of AM and PM total symptom scores). Major secondary endpoints were patient and investigator global assessments of overall efficacy, based on a 5-point scale of major secondary endpoints. Subjects treated with fexofenadine achieved significantly greater improvements in AM, PM and mean total symptom scores compared to placebo-treated patients (P <.0001 for all three scores), the researchers stated. "Significant improvements were also noted for all three scores at weeks 1, 2, 3, and 4 (P =.0179)," they added. "Similarly, global assessments of overall efficacy demonstrated significantly greater symptom improvements for fexofenadine versus placebo, as indicated from both patient and investigator evaluations [P <.0001, for both]." Anguli Nayak, MD, assistant professor of pediatrics, University of Illinois School of Medicine, Peoria, Illinois, United States, commented, "We see in this study that fexofenadine, or Allegra, given once-daily demonstrated efficacy in the relief of symptoms of itching and wheals in patients with chronic idiopathic urticaria." "This is very good news for patients undergoing treatment for chronic idiopathic urticaria," she said. "It simply makes the treatment option simpler without affecting efficacy." The study was supported by Aventis.
[Presentation title: Once-Daily Fexofenadine HCl 180 mg is Effective for the Treatment of CIU. Poster 426]
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