A double-blind, placebo-controlled trial of fexofenadine HCl in the treatment of chronic idiopathic urticaria

Background: Symptoms of chronic idiopathic urticaria (CIU) include relentless itching and painful wheals, which can be physically and psychologically debilitating. Half of all patients with urticaria have angioedema, which is often disfiguring. Objective: To evaluate the safety and efficacy of fexofenadine HCl for the treatment of CIU symptoms, Methods: In this 4-week, multicenter, placebo-controlled study, 439 patients with moderate to severe pruritus and urticaria received 1 of 4 oral doses of fexofenadine HCl (20, 60, 120, or 240 mg twice a day) or placebo. Patients reflectively assessed (over the previous 12 hours) the severity of pruritus, the number of wheals, and the interference with sleep (7 AM) and normal activities (7 PM) due to urticaria, Efficacy measures included a change from baseline of daily mean pruritus score (MPS), daily mean number of wheals (MNW) score, daily mean total symptom score (MTSS) (ie, the sum of the wheal and pruritus scores), and mean interference with sleep and daily activities due to urticaria, Results: All 4 doses of fexofenadine were statistically superior to placebo (P less than or equal to .0338) for MPS, MNW score, and MTSS, Patients receiving fexofenadine HCl also experienced significantly less interference with sleep and daily activities than patients receiving placebo (P less than or equal to .0001). Efficacy results were similar in the 60-, 120-, and 240-mg groups and were quantitatively better than those in the 20-mg group. Adverse events were mild and occurred with similar incidence in all treatment groups, Conclusions: Fexofenadine HCl is web tolerated and is statistically superior to placebo in reducing signs and symptoms of CIU and in ameliorating interference with sleep and daily activities due to urticaria, Doses of 60 mg twice a day or greater are most effective.