Titre du document / Document title

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

Auteur(s) / Author(s)

Star Study Investigating Group
VAN CAUWENBERGE P. ⁽¹⁾ ; JUNIPER E. F. ⁽²⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Department of Otorhinolaryngology, University Hospital, Ghent, BELGIQUE
⁽²⁾ Department of Clinical Epidemiology and Biostatistics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, CANADA

Résumé / Abstract

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 HCI 120mg, 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 HCI (both P ≤ 0.0001) and loratadine (P ≤ 0.001 and P ≤ 0.005, respectively) compared with placebo (n = 639). Among individual symptom scores, fexofenadine HCI 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 HCI 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 HCI and loratadine administered once daily are effective and well tolerated in SAR. In this study, fexofenadine HCI was significantly more effective than loratadine in relieving eye symptoms and nasal congestion. Furthermore, fexofenadine was significantly better than loratadine in improving QoL.

Revue / Journal Title

Clinical and experimental allergy   ISSN 0954-7894 

Source / Source

2000, vol. 30, n^o6, pp. 891-899 (30 ref.)

Langue / Language

Anglais

Editeur / Publisher

Blackwell, Oxford, ROYAUME-UNI  (1989) (Revue)

Mots-clés anglais / English Keywords

Rhinitis ; Allergy ; Human ; Treatment ; Chemotherapy ; Treatment efficiency ; Toxicity ; Quality of life ; Comparative study ; Loratadine ; Antihistaminic ; Antagonist ; H1 Histamine receptor ; Fexofenadine ; Administration schedule ; ENT disease ; Nose disease ; Immunopathology ;

Mots-clés français / French Keywords

Rhinite ; Allergie ; Homme ; Traitement ; Chimiothérapie ; Efficacité traitement ; Toxicité ; Qualité vie ; Etude comparative ; Loratadine ; Antihistaminique ; Antagoniste ; Récepteur histaminergique H1 ; Fexofénadine ; Rythme administration ; ORL pathologie ; Nez pathologie ; Immunopathologie ;

Mots-clés espagnols / Spanish Keywords

Rinitis ; Alergia ; Hombre ; Tratamiento ; Quimioterapia ; Eficacia tratamiento ; Toxicidad ; Calidad vida ; Estudio comparativo ; Loratadina ; Antihistamínico ; Antagonista ; Receptor histaminérgico H1 ; Fexofenadina ; Ritmo administración ; ORL patología ; Nariz patología ; Inmunopatología ;

Localisation / Location

INIST-CNRS, Cote INIST : 15394, 35400008847940.0180