Comparison of the efficacy, safety, and onset of action of mizolastine, cetirizine, and placebo in the management of seasonal allergic rhinoconjunctivitis. MIZOCET Study Group.
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.


CONCLUSIONS
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.
Sabbah
A
A
Centre Hospitalier et Universitaire, Angers, France.
Daele
J
J
Wade
A G
AG
Ben-Soussen
P
P
Attali
P
P
D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D017332:Cetirizine / Q000627:therapeutic use*; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012449:Safety; D013997:Time Factors; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; C076170:mizolastine; D017332:Cetirizine