Get access

Clinical effectiveness and safety of cetirizine versus rupatadine in chronic spontaneous urticaria: a randomized, double-blind, 6-week trial


  • Conflicts of interest: None



Urticaria is a distressing condition associated with diverse clinical presentations. Chronic spontaneous urticaria (CsU) is characterized by wheals and angioedema. Its treatment requires an algorithmic approach to identify the optimum medication.


Cetirizine is commonly used in the treatment of urticaria. Rupatadine is a selective non-sedating H1-antihistamine approved for the treatment of CsU. This trial was conducted to ascertain whether the properties of rupatadine offer advantages over cetirizine.


Seventy patients with CsU were enrolled. Parameters assessed included: (i) mean number of wheals (MNW); (ii) pruritus; (iii) mean total symptom score (MTSS); (iv) size of wheal; (v) interference of wheals with sleep; and (vi) sedation. Patients with CsU were divided randomly into two groups. Routine investigations were performed at baseline and at the end of the study.


Evaluations of MTSS, MNW, and pruritus revealed statistically significant differences at week 3 compared with baseline in the cetirizine group. However, greater reductions in these parameters were obtained with rupatadine. In patients receiving rupatadine, reductions in the MNW, size of wheals, and intensity of erythema were also significant at six weeks (< 0.001) and were significantly greater than those in the cetirizine group (< 0.05).


Improvements in MTSS, MNW, size of wheals, intensity of erythema, and differential eosinophil count imply that rupatadine is a particularly attractive therapeutic modality compared with cetirizine for the treatment of CsU.