Fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria: A placebo-controlled, parallel-group, dose-ranging study

Fexofenadine is a selective, peripheral H1 -receptor antagonist with rapid, long-lasting activity. It is well tolerated, and not associated with sedation or cardiotoxicity. The aim of this multicentre, double-blind, parallel-group, placebo-controlled study was to evaluate the efficacy and safety of once-daily doses of fexofenadine in patients with chronic idiopathic urticaria. Patients were randomized to receive fexofenadine HCI (60, 120, 180 or 240 mg/day) or placebo for 6 weeks (n = 222). The primary endpoint was the mean daily total symptom score (TSS; pruritus plus wheal scores). Secondary endpoints included a series of patient and physician ratings. The 180 mg and 240 mg fexofenadine HCl doses produced significant reductions in TSS compared with placebo (P = 0.0008 and P = 0.0041, respectively). All doses produced a significant improvement in pruritus score (P = 0.0001 versus placebo). Treatment-related adverse events were similar in the fexofenadine and placebo groups. The results indicate that fexofenadine HCl at doses of 180 mg and 240 mg once daily is effective and well tolerated in the treatment of chronic idiopathic urticaria. Since there was no significant difference between the 180 mg/day and 240 mg/day doses across the wide range of patient- and physician-rated scales, the authors recommend fexofenadine HCl 180 mg/day for the treatment of this condition.