Levocetirizine is an effective treatment in patients suffering from chronic idiopathic urticaria: a randomized, double‐blind, placebo‐controlled, parallel, multicenter study

Abstract Background Chronic idiopathic urticaria (CIU) is defined by the almost daily presence of urticaria for at least 6 weeks without an identifiable cause. Symptoms include short‐lived wheals, itching, and erythema. CIU impedes significantly a patient's quality of life (QoL). Levocetirizine is an antihistamine from the latest generation approved for CIU. Aim To investigate the efficacy of levocetirizine, 5 mg, and placebo for the symptoms and signs of CIU, as well as for the QoL and productivity. Methods The primary criteria of evaluation were the pruritus severity scores over 1 week of treatment and over 4 weeks. The QoL was assessed via the Dermatology Life Quality Index (DLQI). Results Baseline pruritus severity scores were comparable in the two treatment groups (2.06 ± 0.58). After 1 week, levocetirizine was superior to placebo and demonstrated a considerable efficacy (difference = 0.78, P < 0.001). This efficacy was maintained over the entire study period (4 weeks, P < 0.001). The number and size of wheals were considerably reduced compared with placebo over 1 week and over the total treatment period ( P ≤ 0.001). This was paralleled by an improvement in the QoL (DLQI: 7.3 units in the levocetirizine group and 2.4 units in the placebo group) and a higher productivity at work in the levocetirizine group (3.0 workdays lost per patient per month in the placebo group, 0.3 in the levocetirizine group). No unexpected adverse events occurred. Conclusions Levocetirizine, 5 mg once daily, is an effective treatment for CIU, characterized not only by a rapid and sustained response, but also by an important improvement in QoL.