Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study

Background Chronic idiopathic urticaria (CIU) is the most common type of ch ronic urticaria, and pruritus is the most prominent symptom. Antihistamines are the first-line treatment for CIU. Sedation and anticholinergic adverse effects are often experienced with the first-generation antihistamines and there is a risk of cardiovascular adverse effects and drug interactions wi th some second-generation agents. Hence, new treatment options are needed. Desloratadine is a new, potent, nonsedating antihistamine that has an excel lent cardiovascular safety profile. Methods This was a multicenter, randomized, double-blind, placebo-controlle d study designed to determine the efficacy and safety of desloratadine in t he treatment of moderate-to-severe CIU. A tot a[ of 190 patients, aged 12-7 9 years, with at least a 6-week history of CIU and who were currently exper iencing a flare of at feast moderate severity, were randomly assigned to th erapy with desloratadine 5 mg or placebo once daily for 6 weeks. Twice dail y, patients rated the severity of CIU symptoms (pruritus, number of hives, and size of largest hive), as well as the impact of CIU symptoms on sleep a nd daily activity. Patients and investigators jointly evaluated therapeutic response and overall condition. Safety evaluations included the incidence of treatment-emergent adverse events, discontinuations due to adverse event s, and changes from baseline in vital signs, laboratory parameters, and ECG intervals. Results Desloratadine was superior to placebo in controlling pruritus and t otal symptoms after the first dose and maintained this superiority to the e nd of the study. Measures of sleep, daily activity, therapeutic response, a nd global CIU status were also significantly better with desloratadine afte r the first dose; these clinical benefits were also maintained throughout t he 6-week study. No significant adverse events occured. Conclusions Desloratadine 5 mg daily is a safe and effective treatment for CIU with significant benefits within 24 h and maintained through the treatm ent period.