Efficacy of Loratadine Compared with Fexofenadine or Placebo for the Treatment of Seasonal Allergic Rhinitis

Harold B. Kaiser, Clinical Research Institute, Minneapolis, Minnesota, USA; Anthony Rooklin, Allergy Research Associates, Media, Pennsylvania, USA; Dennis Spangler, Atlanta Allergy & Immunology Research Foundation, Atlanta, Georgia; David Capano, Integrated Therapeutics Group, Inc., New Jersey, USA

Clin Drug Invest. 2001;21(8) 

In This Article

Results

Eight-hundred and thirty-six patients were randomised to therapy at 25 sites in the United States and received at least one dose of loratadine (n = 357), fexofenadine (n = 360) or placebo (n = 119). Of the 836 randomised patients, 29 did not complete the study (loratadine n = 9; fexofenadine n = 12; placebo n = 8). The reasons for discontinuation were similar between groups except that a greater number of placebo-treated patients (n = 6) than loratadine-or fexofenadine treated patients (n = 3 each) discontinued the study due to treatment failure. Patient demographics and baseline TSS were similar between groups in the ITT population (table III).

Loratadine and fexofenadine provided a similar reduction from baseline in am and pm reflective TSS at final assessment (p = NS for all four assessments). Loratadine and fexofenadine each provided a significant improvement in TSS at the final pm assessments compared with placebo (instantaneous, p = 0.022 and p = 0.011 for loratadine and fexofenadine, respectively; reflective, p = 0.009 and p = 0.005 for loratadine and fexofenadine, respectively).

At the first assessment following the first dose (day 1 pm reflective), loratadine demonstrated a statistically significant reduction from baseline in TSS compared with fexofenadine (-24.5% for loratadine vs -19.0% for fexofenadine, p = 0.023). Loratadine also showed significantly greater (p <0.05 for each) symptomatic relief compared with fexofenadine (fig. 2) at four of the five assessments during the first 3 days of treatment(day 1 pm, day 2 pm, and day 3 am and pm). In addition, time-to-event analysis revealed that loratadine provided a significantly earlier median occurrence of maximum reduction in am reflective TSS compared with fexofenadine (day 4 vs day 5; p = 0.011), as well as a significantly earlier median occurrence of a 25% reduction in am reflective TSS compared with fexofenadine (day 2 vs day 3; p = 0.022). Loratadine and fexofenadine each provided significantly greater reductions in reflective TSS compared with placebo at the final time-point (day 7 pm, p = 0.018 for both loratadine and fexofenadine).

Percentage change from baseline in am and pm mean reflective total symptom severity scores (TSS). * p < 0.025; ** p < 0.014; *** p < 0.001 loratadine vs fexofenadine.

Loratadine and fexofenadine provided significant improvement in investigator-assessed response to therapy compared with placebo (p = 0.001 and p = 0.006 for loratadine and fexofenadine, respectively) and patient-assessed response to therapy compared with placebo (p = 0.001 for both comparisons) assessed at visit 3 (table IV). Patients' satisfaction with loratadine and fexofenadine at visit 3 was similar (p = NS), with each agent providing a significantly greater degree of satisfaction versus placebo (p = 0.035 and p = 0.016 for loratadine and fexofenadine, respectively).

The WPAIQ analysis showed that both loratadine and fexofenadine provided significantly greater benefits than did placebo in hours of work missed (p = 0.01 and p = 0.003, loratadine and fexofenadine, respectively). There was no difference in this measure between loratadine and fexofenadine. At visit 3, the effect of allergies on regular activities was significantly less with loratadine than with placebo (p = 0.016).

All treatments were well tolerated. The overall incidence of treatment-emergent AEs was similar between groups. Treatment-emergent AEs that were possibly, probably or definitely related to treatment occurred in 9.5%, 7.1% and 7.6% of patients in the loratadine, fexofenadine and placebo groups, respectively. Most AEs were mild or moderate in severity. Headache was the most commonly reported adverse event, experienced by 7.0%, 4.4% and 6.7% of patients in the loratadine, fexofenadine and placebo groups, respectively.

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