IngentaConnect Fexofenadine hydrochloride, 180 mg, exhibits equivalent efficacy ...

Authors: Hampel, Frank¹; Ratner, Paul²; Mansfield, Lyndon³; Meeves, Suzanne⁴; Liao, Yuning⁴; Georges, George⁴

Source: Annals of Allergy, Asthma and Immunology, Volume 91, Number 4, October 2003 , pp. 354-361(8)

Publisher: American College of Allergy, Asthma, & Immunology

Abstract:

Background: Previous studies have shown that fexofenadine and cetirizine effectively relieve symptoms of seasonal allergic rhinitis (SAR).

Objective: To compare the effects of fexofenadine hydrochloride, 180 mg, and cetirizine, 10 mg, on symptoms, drowsiness, and motivation in patients with moderate-to-severe SAR.

Methods: In this 2-week multicenter, double-blind, randomized study, 495 subjects with moderate-to-severe SAR received once-daily fexofenadine hydrochloride, 180 mg, or cetirizine, 10 mg, without regard to food intake. Daily 12-hour reflective (am, pm) and instantaneous (am) individual symptoms and total symptom score (TSS) were evaluated. Drowsiness and motivation were recorded daily using visual analog scale at 7 am, 10 am, and 3 pm.

Results: Between-treatment differences in reduction from baseline in am instantaneous and 24-hour reflective TSS were −0.18 [95% confidence interval (CI), −0.55 to 0.20) and −0.22 (95% CI, −0.59 to 0.15), respectively. Since CIs for reduction in TSS between treatments fell within a 0.7 margin (defined a priori), treatments were considered statistically equivalent. Patients receiving fexofenadine experienced significantly less overall drowsiness vs baseline than those receiving cetirizine [−2.33 (95% CI, −3.80 to 0.86) vs 0.37 (95% CI, −1.10 to 1.84), P = .0110]. There was a trend toward greater improvements in overall motivation with fexofenadine compared with cetirizine [−2.36 (95% CI, −3.83 to 0.90) vs −0.30 (95% CI, −1.76 to 1.17),P = .0504].

Conclusions: Once-daily fexofenadine hydrochloride, 180 mg, given for 2 weeks caused statistically and clinically equivalent improvement in symptoms and significantly less drowsiness va baseline, compared with cetirizine, 10 mg, in patients with moderate-to-severe SAR.

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Fexofenadine hydrochloride, 180 mg, exhibits equivalent efficacy to cetirizine, 10 mg, with less drowsiness in patients with moderate-to-severe seasonal allergic rhinitis