The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone andin combination, in seasonal allergic rhinitis

Background: Antihistamines effectively treat seasonal allergic rhinitis (SA R), although the ability of this drug class to reduce nasal congestion is l imited. Nasal decongestants effectively treat nasal congestion but not the histamine-related components of SAR. Therefore antihistamine/nasal deconges tant combinations are commonly used to maximize the treatment of SAR, Fexof enadine HCl is a nonsedating, long-acting H-1 receptor antagonist that prov ides fast and effective relief from SAR. It is well tolerated, with no seda tive or cardiotoxic effects. Objective: We sought to compare the efficacy and safety of a fexofenadine H Cl/pseudoephedrine HCl combination with that of each individual component i n the treatment of ragweed allergy, Methods: In this Canadian multicenter, double-blind, parallel-group study, 651 patients allergic to ragweed were randomized to receive 60 mg of fexofe nadine HCl twice daily, 120 mg of sustained-release pseudoephedrine HCl twi ce daily, or a combination of the 2 drugs (60 mg of fexofenadine HCl/120 mg of sustained-release pseudoephedrine HCl) twice daily for 2 weeks, Efficac y analyses were based on symptom severity. In addition, a health economic a ssessment was performed, Results: Combination therapy was significantly more effective than pseudoep hedrine alone in improving primarily histamine-mediated symptoms (sneezing; rhinorrhea; itchy nose, palate, and/or throat; and itchy, watery, red ea e s) and significantly more effective than fexofenadine alone in reducing nas al congestion. Combination therapy also produced greater improvements in da ily activities and work productivity compared with the individual component s. No serious adverse events were reported in any of the treatment groups. In addition, no clinically significant changes in 12-lead electrocardiogram parameters, vital signs, or clinical laboratory values were observed. Conclusion: Combination therapy is more effective than fexofenadine alone o r pseudoephedrine alone in relieving the full spectrum of SAR symptoms tie, both the primarily histamine-related symptoms and nasal congestion).