@article {Hampel:October 2003:1081-1206:354, author = "Hampel, Frank", author = "Ratner, Paul", author = "Mansfield, Lyndon", author = "Meeves, Suzanne", author = "Liao, Yuning", author = "Georges, George", title = "Fexofenadine hydrochloride, 180 mg, exhibits equivalent efficacy to cetirizine, 10 mg, with less drowsiness in patients with moderate-to-severe seasonal allergic rhinitis", journal = "Annals of Allergy, Asthma and Immunology", volume = "91", year = "October 2003", 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.", pages = "354-361(8)", url = "http://www.ingentaconnect.com/content/acaai/aaai/2003/00000091/00000004/art00010" }