Fexofenadine hydrochloride, 180 mg, exhibits equivalent efficacy to cetirizine, 10 mg, with less drowsiness in patients with moderate-to-severe seasonal allergic rhinitis
Authors: Frank Hampel1; Paul Ratner2; Lyndon Mansfield3; Suzanne Meeves4; Yuning Liao4; George Georges4
Source: Annals of Allergy, Asthma and Immunology, Volume 91, Number 4, October 2003 , pp. 354-361(8)
Publisher: American College of Allergy, Asthma, & Immunology
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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.Document Type: Original article
Affiliations: 1: Central Texas Health Research, New Braunfels, Texas. 2: Sylvana Research, San Antonio, Texas. 3: Western Sky Medical Research, El Paso, Texas. 4: Aventis Pharmaceuticals, Bridgewater, New Jersey.
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