Rupatadine safe, effective for treating chronic spontaneous urticaria
Rupatadine effectively relieves pruritus in patients with chronic spontaneous urticaria (CSU) and is well tolerated without serious or clinically significant adverse effects, according to the results of a phase III trial.
The trial randomized adolescent (n=15) and adult (n=261) Japanese patients to treatment with rupatadine at either 10 mg (n=91) or 20 mg (n=91) or placebo (n=94) once daily for 2 weeks. Total pruritus score (TPS; sum of daytime and night-time scores) was assessed as the primary endpoint.
Efficacy results favoured both rupatadine doses. At the end of treatment, changes in mean TPS were greater with the 10- and 20-mg doses vs placebo (differences, −1.956 and −2.121, respectively; analysis of covariance, p<0.001 for both).
Adverse events (AEs) occurred in 20.9 percent of patients in the 10-mg group, 17.4 percent in the 20-mg group and in 8.5 percent in the placebo group. Somnolence was the only adverse reaction associated with the study drug, documented in 10 patients who received the lower dose and in nine of those who received the higher dose. There were no reports of serious or clinically significant AEs.
The present data show that rupatadine is effective at a dose of 10 mg once daily in the treatment of CSU and can be safely increased to 20 mg once daily, as necessary, researchers said. Furthermore, the results provide positive evidence for the effect of the drug in adolescent patients, despite the small sample size.
Study limitations include the short duration of rupatadine treatment and the fact that dose titration was not an option owing to the administration of fixed doses.
Additional studies are required to characterize the clinical benefits and risk of long-term rupatadine use and dose increase from 10–20 mg, researchers added.