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Safety and Efficacy of Once-Daily Fexofenadine HCl in the Treatment of Autumn Seasonal Allergic Rhinitis

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Fexofenadine HCl (Allegra, Telfast) is approved in the US for twice-daily dosing in the treatment of seasonal allergic rhinitis (SAR). A once-daily dose (already available in some countries outside the US) can improve patient compliance and health outcomes. This multicenter, placebo-controlled, 14-day US study was conducted to compare the safety and effectiveness of once-daily fexofenadine HCl with placebo in the treatment of patients with moderate to severe autumnal SAR symptoms. After a 1-week placebo lead-in, patients received 120 or 180 mg fexofenadine HCl or placebo at 8 A.M. Patients recorded SAR symptom severity scores instantaneously (for the 1 hour before medication; i.e., trough blood levels), and reflectively (for the previous 12 hours) at 8 A.M. and 8 P.M. The primary efficacy measure was change from baseline in average instantaneous 8 A.M. total symptom score (TSS, the sum of individual symptom scores excluding nasal congestion). In 861 intent-to-treat patients, both fexofenadine HCl doses provided significant (p ≤ 0.05) improvement in 8 A.M. instantaneous TSS compared with placebo. Similarly, both fexofenadine doses were superior to placebo for reflective TSS assessments (p ≤ 0.0012). There were no statistical differences in efficacy between the two fexofenadine doses, though the 180 mg dose showed a trend toward greater symptom relief. Incidence of adverse events was similar between fexofenadine and placebo groups (30.2% and 30.0%, respectively), with headache the most frequently reported adverse event (8.9% and 7.5%, respectively). In conclusion, once-daily fexofenadine HCl, 120 or 180 mg, is safe and effective in the treatment of autumnal SAR.
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Document Type: Research Article

Publication date: 01 May 1999

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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