Comparison of the efficacy, safety, and onset of action of mizolastine, cetirizine, and placebo in the management of seasonal allergic rhinoconjunctivitis
Authors: Sabbah, Alfred; Daele, Jacques; Wade, Alan Grierson; Ben-Soussen, Paul; Attali, Pierre
Source: Annals of Allergy, Asthma and Immunology, Volume 83, Number 4, October 1999 , pp. 319-325(7)
Publisher: American College of Allergy, Asthma, & Immunology
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Abstract:
Background: Mizolastine is a potent and selective H1-receptor antagonist with additional anti-allergic properties. Objective: The aim of this European multicenter, randomized, double-blind study was to compare the efficacy of mizolastine 10 mg (n = 122), cetirizine 10 mg (n = 125), and placebo (n = 128) once daily for 28 days in patients with seasonal allergic rhinoconjunctivitis (SAR), with focus on the onset of action. Methods: Symptoms were evaluated by the investigator using a total symptom score (TS) and by the patient (first week). Responders (R) were patients with a TS decrease of at least 50%. Safety was assessed according to the spontaneous reporting of adverse events. Results: Both mizolastine and cetirizine were effective in relieving the symptoms of SAR. After 7 days of treatment, the improvement in TS and responder's rate were significantly (P < .05) greater in patients treated with mizolastine (TS change versus baseline, mean ± SD: -6.40 ± 5.71; R: 55%) and cetirizine (TS change versus baseline: -6.24 ± 5.24; R: 53%) than with placebo (TS change versus baseline: -4.11 ± 5.91; R: 40%). Both drugs acted rapidly, within 2 hours of the first intake. During the first 3 days, mizolastine relieved symptoms more effectively than cetirizine, the difference being significant on the second (P = .027) and third (P = .050) day. Both mizolastine and cetirizine were well tolerated. Conclusion: Mizolastine 10 mg once daily is at least as effective as cetirizine in relieving symptoms of SAR, onset of action is rapid with clinical effect evident within 2 hours. Annals of Allergy, Asthma, & Immunology 1999;83:319-325.Document Type: Original article
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