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


The results of this randomised, double-blind, double-dummy, placebo-controlled, parallel-group study demonstrate the efficacy of loratadine and fexofenadine in relieving the common symptoms of SAR, confirming the results of earlier studies.[9,10,11,12,13,14] While most published trials have identified no significant differences between these agents, the results of some studies[13,14] have favoured either loratadine or fexofenadine, though not consistently.

In the present study, however, loratadine provided significantly greater (p < 0.05) relief at the first assessment after the initiation of therapy and earlier maximal relief compared with fexofenadine. Significantly greater symptomatic relief was observed among patients taking loratadine at the first assessment, 12 hours after the first dose. Loratadine also provided significantly greater improvement in am and pm reflective TSS in four of five assessments within the first 3 treatment days when compared with fexofenadine. At the day 7 pm reflective assessment, the percentage change from baseline TSS was similar in the loratadine and fexofenadine groups. Patients frequently take medications for symptomatic relief on an as needed basis in response to the occurrence of SAR symptoms; there is, therefore, a practical need for medications that provide early relief.

Previous studies have investigated the onset of action of newer antihistamines by assessing the time to first clinically meaningful symptom relief after a single dose of study medication.[15,16,17] In this study, carried out over 1 week, the times to first substantial symptom relief (25% reduction in am reflective TSS from baseline) and maximal symptom relief after multiple doses were assessed. These results indicate that, compared with fexofenadine, loratadine provides a significantly greater degree of relief 12 hours after initiation of therapy and achieves maximal benefit significantly earlier in therapy.

The relief in SAR symptoms provided by loratadine and fexofenadine is also reflected in significantly superior benefit in investigator-and patient-assessed response to therapy, patient satisfaction with treatment, and WPAIQ scores compared with placebo.

Loratadine and fexofenadine are newer anti-histamines that are rapidly absorbed following oral administration; these agents do not readily penetrate the blood-brain barrier and are not associated with the sedation common with older anti-histamines. In this study, loratadine and fexofenadine were well tolerated in patients with SAR; most AEs were mild or moderate in severity, and discontinuations due to AEs were rare.