EFFECTIVENESS AND SAFETY OF FEXOFENADINE, A NEW NONSEDATING H-1-RECEPTOR ANTAGONIST, IN THE TREATMENT OF FALL ALLERGIES

Fexofenadine HCl is a new nonsedating H-1-receptor antagonist approved for treatment of seasonal allergic rhinitis (SAR). In a double-blind, randomized placebo-controlled multicenter trial, 588 patients with fa ll SAR rated the severity of their symptoms using a scoring system at a screening visit and during a 3-day placebo lend-in period. Patients who did not respond to placebo and met symptom severity criteria were randomized to receive placebo or fexofenadine HCl at 40, 60, or 120 mg bid at 7:00 am. and 7:00 p.m. for 14 days. Patients continued to rate the severity of their symptoms immediately before receiving each dose (at trough). A total of 545 patients were included in an intent-to-tr eat analysis. The change from baseline in the primary efficacy variabl e (average daily 7:00 p.m. reflective symptom scores) was significantl y greater in patients receiving all dosages of fexofenadine HCl than p lacebo (p < 0.01). All active dosages produced significant decreases ( p < 0.05) in secondary end points: 7:00 a.m, reflective symptom scorin g; 7:00 a,m. and 7:00 p.m scoring 1-hour before dose; and bedtime scor ing 1-3 hours after the 7:00 p.m, dose. All dosages of fexofenadine HC l were well tolerated and no effect on QT(c) was observed. In conclusi on, fexofenadine HCl is safe and effective in the treatment of fall SA R, with 60 mg bid being the optimal therapeutic dosage.