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.
RCT Entities:
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.
Authors: Jörg Täubel; Georg Ferber; Sara Fernandes; Ulrike Lorch; Eva Santamaría; Iñaki Izquierdo Journal: PLoS One Date: 2016-09-15 Impact factor: 3.240