Abstract

Rupatadine 10 mg in adolescent and adult symptom relief of perennial allergic rhinitis

Author(s): Montserrat Molina, Esther Pinto, Anna Cistero, Remedios Alamar Martinez, Jose Montero, Juan Jesus Garcia-Gonzalez, Joan Serra, Fernando de la Torre, Inaki Izquierdo and the Rupatadine Study Group

Background & objectives: This randomized, double-blind clinical trial assessed the efficacy and safety of rupatadine 10 mg administered once-daily for 4 weeks compared with placebo and ebastine 10 mg in the management of symptoms of perennial allergic rhinitis (PAR).
Methods: We randomly assigned 223 patients to receive placebo (n = 73), ebastine 10 mg (n = 79) or rupatadine 10 mg (n = 71). The efficacy and safety population analysis included 219 patients. The efficacy assessment was based on patients’ reflective assessment of the severity of symptoms in a diary card. Symptoms of allergic rhinitis included rhinorrhea, sneezing, nasal itching, nasal obstruction and ocular itching. The main variable of efficacy 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 (5TSS) and nasal symptom score (4TNSS) were measured, as well as investigators’ and patients’ global assessment of efficacy.
Results: Pdmax1 was nonsignificantly lower for rupatadine 10 mg (49%) and ebastine 10 mg (51%) than for placebo (42%) at the end of the study period. Both 5TSS and 4TNSS were significantly improved for rupatadine 10 mg users compared with placebo (p = 0.019 and p = 0.025, respectively). No significant differences were seen between active treatments. All treatments were similarly safe and well tolerated, with headache (33%) and somnolence (17%) as the most often reported adverse events in all treatment groups.
Conclusions: Symptomatic relief of PAR symptoms with rupatadine 10 mg was rapidly and effectively attained. A 4-week treatment of patients suffering from PAR with rupatadine 10 mg is as effective and well tolerated as ebastine 10 mg.