Fexofenadine HCI is safe and effective for treatment of chronic idiopathicurticaria

Background: Fexofenadine is a nonsedating antihistamine approved for treatm ent of seasonal allergic rhinitis. Objective: This dose-finding study assessed the safety and efficacy of fexo fenadine in chronic idiopathic urticaria. Methods: The 4-week, double-blind, randomized, placebo-controlled study inc luded patients diagnosed with chronic urticaria who had moderate to severe pruritus. Patients received twice daily oral doses of placebo off fexofenad ine HCl (20, 60, 120, or 240 mg) at 7 AM and 7 PM. Patients recorded scores for pruritus severity and number of wheals lover the previous 12 hours) in a daily diary. Efficacy variables included mean daily changes from baselin e in pruritus severity, number of wheals, and interference with sleep and d aily activities due to urticaria. Results: Patients (N = 418) from 37 investigative sites were included. All four fexofenadine HCl doses were statistically superior to placebo (P less than or equal to.0115) for reducing pruritus and number of wheals scores ov er the 4-week treatment period. There were greater reductions in urticaria symptoms in the 60 mg fexofenadine HCl group than in the 20 mg group, while similar reductions were observed in the 60, 120, and 240 mg dose groups. A dditionally, patients receiving fexofenadine experienced significantly less interference with sleep and daily activities than patients receiving place bo (P less than or equal to.0014). Adverse events occurred with similar inc idence in all treatment groups, with no dose-related increases in any event . Conclusions: Fexofenadine HCl significantly reduced pruritus severity, numb er of wheals, and interference with sleep and normal daily activities in pa tients with chronic urticaria compared with placebo. Twice-daily doses of 6 0 mg or greater were most effective.