EFFICACY AND SAFETY OF MIZOLASTINE IN SEASONAL ALLERGIC RHINITIS

Background: Mizolastine is a new, nonsedating antihistamine under clin ical investigation for treatment of allergic rhinitis and urticaria. O bjective: The purpose of this study was to determine the optimally act ive dose of once-daily mizolastine in seasonal allergic rhinitis. Meth ods: This multicenter, double-blind, parallel study involved 494 patie nts randomly allocated to mizolastine (5, 10, or 15 mg) or placebo for 2 weeks. Results: Physicians' assessments indicated the superiority o f 10 and 15 mg mizolastine to placebo in reducing total symptom scores (P = .002), nasal scores (P = .004), and ocular scores (P = .007) at day 7. Patients' diaries showed a significant change from baseline in daily symptom scores as early as day 2 (P = .01) in 10- and 15-mg mizo lastine groups in comparison to placebo, but this was not maintained t hroughout the study. No additional benefits were demonstrated during t he second week of treatment in terms of efficacy. Adverse events were slightly more frequent in the 15-mg mizolastine group. Conclusion: Thi s study confirms mizolastine is an effective and well tolerated antihi stamine in the treatment of seasonal allergic rhinitis; 10 mg is the o ptimal dose.