Abstracto

Rupatadine 10 and 20 mg are effective and safe in the treatment of perennial allergic rhinitis after 4 weeks of treatment: a randomized, double-blind, controlled trial with loratadine and placebo

Marek L Kowalski, Dariusz Jurkiewicz, Jerzy Kruszewski, Dariusz Nowak, Ziemowit Zietkowski, Marie Spicakova, Eva Vernerova, Ester Seberová, Kamil Klenha and Inaki Izquierdo

Background and objectives: Allergic rhinitis is a global health concern of increasing prevalence that can impact quality of life and work and school performance of affected individuals. Antihistamines are recommended as the first-line treatment. This randomized, controlled trial aimed to investigate the effects of rupatadine in adult subjects with perennial allergic rhinitis. Methods: We randomly assigned 283 patients to receive placebo (n = 69), loratadine 10 mg (n = 70), rupatadine 10 mg (n = 73) or rupatadine 20 mg (n = 71). The study design was double blind and treatment was continued for 4 weeks. Subjective assessment of symptoms (reflective evaluation) was recorded by patients in a diary card. The primary end point was the percentage of days where the score of the most severe symptom was less than or equal to one (Pdmax1). Furthermore, the change from baseline in the severity of total symptom score and nasal symptom score were recorded, and the investigator and patient global assessments were evaluated. Results: All 283 patients were included in analyses (intention to treat); 265 (94%) patients completed the follow‑up. Rupatadine 20 mg significantly improved the Pdmax1 in comparison with placebo. Significant reductions from baseline in total symptom score were achieved with rupatadine 10 mg (-4.00), rupatadine 20 mg (-3.96) and loratadine (-3.94) compared with placebo (p < 0.01). Similarly, all three active treatments significantly reduced the nasal symptom score compared with placebo. No significant differences among groups in the incidence of overall adverse events were observed and no clinically significant QTc enlargements were detected. More patients receiving rupatadine complained of somnolence compared with loratadine. Conclusion: Once-daily rupatadine (10 and 20 mg) is an efficacious and safe treatment for the management of patients with perennial allergic rhinitis.