Background: Fexofenadine is a nonsedating antihistamine approved for treatment of seasonal allergic rhinitis.
Objective: This dose-finding study assessed the safety and efficacy of fexofenadine in chronic idiopathic urticaria.
Methods: The 4-week, double-blind, randomized, placebo-controlled study included patients diagnosed with chronic urticaria who had moderate to severe pruritus. Patients received twice daily oral doses of placebo or fexofenadine HCl (20, 60, 120, or 240 mg) at 7 AM and 7 PM. Patients recorded scores for pruritus severity and number of wheals (over the previous 12 hours) in a daily diary. Efficacy variables included mean daily changes from baseline in pruritus severity, number of wheals, and interference with sleep and daily 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 < or = .0115) for reducing pruritus and number of wheals scores over 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. Additionally, patients receiving fexofenadine experienced significantly less interference with sleep and daily activities than patients receiving placebo (P < or = .0014). Adverse events occurred with similar incidence in all treatment groups, with no dose-related increases in any event.
Conclusions: Fexofenadine HCl significantly reduced pruritus severity, number of wheals, and interference with sleep and normal daily activities in patients with chronic urticaria compared with placebo. Twice-daily doses of 60 mg or greater were most effective.