Rupatadine and Levocetirizine in Chronic Idiopathic Urticaria: A Comparative Study of Efficacy and Safety
December 2011 | Volume 10 | Issue 12 | Original Article | 1444 | Copyright © December 2011
Background: Chronic Idiopathic Urticaria is difficult to treat due to its persistent debilitating symptoms. New generation anti-histaminics are first line treatment for this condition. The aim of this study is to compare efficacy and safety of rupatadine and levocetirizine in chronic idiopathic urticaria.
Methods:A randomized, single blinded, single-centred, parallel group outdoor based clinical study was conducted in 70 patients of CIU to compare the two drugs. After initial clinical assessment and baseline investigations, rupatadine was prescribed to 35 patients and levocetirizine
to another 35 patients for 4 weeks. At follow-up, the patients were re-evaluated and then compared using different statistical tools. Main outcome measures were DC eosinophil, Absolute Eosinophil Count (AEC), serum IgE, Total Symptom Score, Aerius Quality of Life Questionnaire score, and Global efficacy score.
Results:Rupatadine significantly improved patients′ clinical condition including symptom score from baseline to day 28. In rupatadine group, there was 27.9 percent decrease (P=0.027) in DC eosinophil, 35.6 percent decrease (P=0.036) in AEC, 15.3 percent decrease (P=0.024) in serum IgE, 28.2 percent decrease (P=0.02) in Total Symptom Scoring, and 27.3 percent decrease (P=0.006) in Aerius Quality of Life Questionnaire score. Global efficacy score of rupatadine was found to be significantly greater (P=0.009) than levocetirizine. The overall incidence of adverse drug reactions was also found to be less in rupatadine group
Conclusion: Rupatadine is a better choice in CIU in comparison to levocetirizine due to better efficacy and safety profile.
J Drugs Dermatol. 2011;10(12):1444-1450.
Urticaria is a fairly common condition characterized by circumscribed, edematous, itchy lesions. This could be an extremely disabling, difficult-to-treat condition and severely affects patients′ quality of life and performance. Chronic urticaria has multifactorial aetiologies including intolerance
to food or drugs, infectious diseases, and autoimmune processes. Conventionally, it is defined as the repeated occurrence
of daily or almost daily cutaneous wheals accompanied by redness and itching for more than six weeks. Clarity of nomenclature
is required not only to choose the correct measures in diagnosis and management, but also to compare data from different studies. Traditionally urticaria is classified into acute and chronic, with a time division arbitrarily chosen at 6 weeks to 3 months. Even after evaluation for evidence of autoimmunity
and other provoking factors, approximately 50 percent of cases of chronic urticaria remain unexplained and are categorized
as Chronic Idiopathic Urticaria (CIU). In most series, this subgroup represents a substantial number of patients but must remain a diagnosis of exclusion.1-3
As histamine is the most important mediator of urticaria and degranulation
of mast cells with release of histamine is central to its pathophysiology, H1 antihistamines represent the initial and mainstay treatment of all urticarias.4-6 Different studies on role of antihistamines in chronic urticaria showed response rate of up to 91 percent.7 The newer generation H1 antihistamines with less sedating and less cholinergic effects are preferred over the older generation H1 antihistamines as the initial choice of therapy. 8 During recent years, new antihistamines like rupatadine and levocetirizine have been marketed and have been indicated in the treatment of CIU with the benefit of a better safety profile.9-16
Although individually rupatadine and levocetirizine are efficacious
in CIU, unique findings in some studies indicate a likelihood of differences between these two drugs.16-22 This study was conducted to compare the therapeutic efficacy and tolerability
of levocetirizine and rupatadine in patients suffering from CIU. The relative absence of data in this domain was an incentive to further explore this aspect of the disease.