Futura study: evaluation of efficacy and safety of rupatadine fumarate in the treatment of persistent allergic rhinitis

Abstract

Al lergic rhinitis affects 10-30% of the population, negatively impacting one's quality of life and productivity. It has been associated with sinusitis, otitis media, sleep disorders, and asthma. Rupatadine is a second generation antihistamine with increased affinity to histamine receptor H1; it is also a potent PAF (platelet-activating factor) antagonist. It starts acting quite quickly, offers long lasting effect, and reduces the chronic effects of rhinitis. Aim: this study aims to assess the efficacy and safety of rupatadine in the treatment of persistent allergic rhinitis. Materials and method: this is a multi-centric open prospective study. This study included 241 patients from 13 centers in Brazil and was held between October of 2004 and August of 2005. Signs and symptoms of rhinitis and tolerance to medication were analyzed after one and two weeks of treatment. Results: reduction on general scores from 8.65 to 3.21 on week 2 (p<0.001). All signs and symptoms improved significantly in the first day of treatment (p<0.001), except for nasal congestion and secretion, which improved from the second day of treatment (p<0.001). Adverse events occurred in 19.9% of the cases, 27.7% on week 1. Conclusion: rupatadine effectively controls persistent allergic rhinitis; it is safe and presents low incidence of side effects.

Clinical effectiveness and safety of cetirizine versus rupatadine in chronic spontaneous urticaria: a randomized, double‐blind, 6‐week trial

“…We did not find any significant change in biochemical parameters with either drug. This observation supports the findings of a previous study on the safety of rupatadine …”

“…Thus, this increase in the incidence of adverse events may be attributable to the more thorough reporting of adverse events in comparison with that in studies in which patients have reported adverse events spontaneously. We found no changes in ECG, in line with previous studies that have reported similar ECG findings …”

Comparison of efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis: A prospective, randomized, double-blind, parallel group study

“…This observation supports the previous study of analysis of rupatadine and olopatadine. [26] There was no significant difference in differential monocyte count and differential basophil count in both groups. In our study, we did not find any significant change in biochemical parameters.…”

“…[6] Another comparative dose ranging trial of rupatadine showed improvement in nasal and ocular symptoms of AR. [10] Our study supports this finding of a significant reduction in symptom score and improvement in nasal symptoms.…”

“…[45] Rupatadine is a selective and long-acting oral histamine H1-receptor antagonist that has also been shown to have PAF antagonist activity. [6] It is indicated for use in AR and chronic idiopathic urticaria in patients aged 12 years or more. [7]…”