Rupatadine in the treatment of chronic idiopathic urticaria: a double‐blind, randomized, placebo‐controlled multicentre study

Background: Chronic urticaria is one of the most common and disturbing cutaneous condition. The treatment of chronic idiopathic urticaria (CIU) is still a challenge. Antihistamines are recommended as first‐line treatment. Rupatadine is a new potent nonsedative anti‐H 1 . Objective: To study rupatadine efficacy and safety for moderate to severe CIU treatment. Methods: This randomized, double‐blind, placebo‐controlled, parallel‐group, multicentre, study was designed to assess primarily mean pruritus score (MPS) reduction with rupatadine, 10 and 20 mg, administered once daily for 4 weeks. Three hundred and thirty‐three patients with active episodes of moderate‐to‐severe CIU were included. Results: A 57.5% ( P < 0.005) and 63.3% ( P = 0.0001) significative MPS reduction from baseline, was observed at week 4 with 10 and 20 mg rupatadine, respectively, compared with placebo (44.9%). Both doses of rupatadine were not significantly different at any time point, with respect to their effects on pruritus severity, number of wheals and total symptoms scores. Rupatadine 10 mg had an overall better adverse event profile. Conclusion: Rupatadine 10 mg is a fast, long‐acting, efficacious and safe treatment option for the management of patients with moderate‐to‐severe CIU.