Non-sedating antihistamines in the treatment of chronic idiopathic urticaria using patient-reported outcomes

Abstract

ABSTRACTBackground: Chronic idiopathic urticaria (CIU) greatly impairs quality of life (QoL). Thus, patient-reported outcome (PRO) measures, using validated scoring instruments, are probably the most accurate tools available for assessing the efficacy of medications that treat CIU, such as second-generation antihistamines.Research methods: A structured search of the MEDLINE database was conducted to identify English-language papers published between 1 January 1991 and 30 September 2007 on the treatment of CIU with the second-generation antihistamines cetirizine, desloratadine, fexofenadine, and levocetirizine, and their effects on patient-reported QoL. We used the following search terms alone or in combination: ‘chronic idiopathic urticaria’; ‘pruritus’; ‘wheals’; ‘hives’; ‘second-generation antihistamines’; ‘cetirizine’; ‘desloratadine’; ‘fexofenadine’; ‘levocetirizine’; and ‘quality of life’.Scope: We evaluated the effects of second-generation antihistamines on the QoL of subjects with CIU using desloratadine as a treatment model. Desloratadine was selected because it is the most frequently assessed non-sedating second-generation antihistamine in QoL studies in patients with CIU.Findings: Desloratadine 5 mg QD improved QoL in numerous PRO studies. Treatment with desloratadine significantly (p < 0.05) lowered (better) scores in three studies (n = 364) that used validated dermatology-specific scoring instruments. Three 6-week double-blind, placebo-controlled trials (n = 553) found that desloratadine significantly (p < 0.05) improved patient-reported pruritus, sleep disruption, and interference with daily activities. Desloratadine was associated with a low incidence of adverse events and an overall tolerability profile similar to placebo.Limitations: Limitations in this review include divergence in search practices that may lead to omission of relevant research, unintentional error in data transfer, inconsistency in quality of selected papers, and potential publication bias against papers that report results from small studies.Conclusions: The favorable impact of second-generation antihistamines on the QoL of patients with CIU was demonstrated using desloratadine, the most frequently investigated drug in this field, as a treatment model.