Efficacy of leukotriene receptor antagonist in chronic urticaria. A double-blind, placebo-controlled comparison of treatment with montelukast and cetirizine in patients with chronic urticaria with intolerance to food additive and/or acetylsalicylic acid

Background The cause and pathogenesis of chronic urticaria are still poorly understood. IgE-independent reactions, are common in adult patients with c hronic urticaria, who have daily spontaneous occurrence of weals. H-1-recep tor antagonists (antihistamines) are the major class of therapeutic agents used in the management of urticaria and angioedema. Nevertheless, chronic u rticaria is often difficult to treat and may not be controlled by antihista mines alone. It has been postulated that mediators other than histamine, su ch as kinins, prostaglandin and leukotrienes, may be responsible for some o f the symptoms in urticaria which are not controlled by antihistamines. In this study, which was randomized double-blind, placebo-controlled, we compa re the clinical efficacy and safety of montelukast (MT) 10 mg given once a day and cetirizine (CET) 10 mg given once a day with placebo (PLA), in the treatment of patients with chronic urticaria who have positive challenge to acetylsalicylic acid (ASA) and/or food additives. Patients and methods A group of 51 patients, ranging in age from 15 to 71 y ears, with chronic urticaria and positive challenge to food additives and/o r ASA, participated in this study for a period of 4 weeks, starting from a 3-day run-in. The assessment of the efficacy was based on scores of daily u rticaria symptoms. Results MT significantly increased the percentage of symptom-free days for hive and itch. Analysis of frequency distribution of urticaria scores for e ach symptom gave similar results (MT vs. CET and MT vs. PLA, P < 0.001). Th e interference with sleep due to their skin condition was also lower in the group treated with MT (P < 0.001). In addition, the median number of days without the rescue medication was significantly higher in the MT group (24 days) than both the CET and the PLA groups (18 days, P < 0.001, and 20 days , P, < 0.001, respectively). Finally, a low incidence of adverse events was observed in this study. Conclusion The results of this comparative study demonstrate that monteluka st orally administered once a day is very effective for the treatment of cu taneous symptoms in patients with chronic urticaria due to food additives a nd/or ASA.