BACKGROUND: Post-marketing surveillance studies (PMSS) of medications are often mandated by authorities, provide crucial insights for health services and are useful to define the clinical profiles of therapies. Desloratadine, a non-sedating, second-generation H(1)-receptor antagonist, is an effective and well-tolerated treatment for chronic idiopathic urticaria (CIU). METHODS: A PMSS in CIU patients evaluated the tolerability and efficacy of desloratadine in clinical practice. At Visit 1 (baseline), demographic and CIU history were recorded and patients/physicians rated the severity of CIU symptoms, interference with sleep/daily activities and the general state of urticaria. Patients also noted the use and effectiveness of previous antihistamine therapy. At the end of treatment (Visit 2), CIU symptom severity and other disease criteria were re-assessed. Adverse events reported during or <or = 30 days after treatment were collected. RESULTS: A total of 9246 patients with CIU participated (63% female). Itching, number of wheals and the size of the largest wheal decreased significantly from baseline with desloratadine therapy (P <0.0001). Improvements in CIU-impaired sleep and daily activities were reported by 67% and 71% of patients, respectively (P <0.0001). In patients that received previous therapy with cetirizine, loratadine or fexofenadine alone, patients rated the onset of efficacy of desloratadine as faster in 55.5%, 54.7% and 57.6% of cases, respectively. The incidence of adverse events was low (0.5% of patients) and no serious adverse events were reported. CONCLUSIONS: This large PMSS confirms evidence from multiple placebo-controlled trials that desloratadine is effective and well tolerated in the treatment of CIU.
