Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis

BACKGROUND: As there have been no previously published studies, this multinational, double-blind, randomized, placebo-controlled, parallel group study compared the efficacy, safety and impact on quality of life (QoL) in seasonal allergic rhinitis patients (SAR) of fexofenadine and loratadine (with placebo), when administered once daily. METHODS: Six hundred and eighty-eight SAR patients were randomized to receive fexofenadine HCl 120 mg, loratadine 10 mg or placebo, once daily for 2 weeks. The key parameters were the change from baseline in: mean 24-h reflective total symptom scores (TSS); sum of four individual symptom scores, excluding nasal congestion; instantaneous TSS; individual symptom scores including nasal congestion; and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Adverse events were recorded. RESULTS: Mean 24-h reflective and instantaneous TSS were significantly reduced by both fexofenadine HCl (both P </= 0.0001) and loratadine (P </= 0.001 and P </= 0.005, respectively) compared with placebo (n = 639). Among individual symptom scores, fexofenadine HCl was significantly better than loratadine in improving 24-h reflective itchy, watery, red eyes, as well as relieving nasal congestion (P </= 0.05 for both). Fexofenadine HCl was also significantly better than loratadine (P </= 0.03) and placebo (P </= 0.005) in improving QoL, and the differences were of a magnitude considered to be clinically relevant. Loratadine had no statistically significant effect on QoL compared with placebo. The incidence of adverse events was low and similar across all treatment groups. CONCLUSION: Fexofenadine HCl and loratadine administered once daily are effective and well tolerated in SAR. In this study, fexofenadine HCl was significantly more effective than loratadine in relieving eye symptoms and nasal congestion. Furthermore, fexofenadine was significantly better than loratadine in improving QoL.