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Ann Allergy Asthma Immunol. 2010 Jan;104(1):86-92. doi: 10.1016/j.anai.2009.11.013.

Rupatadine and its effects on symptom control, stimulation time, and temperature thresholds in patients with acquired cold urticaria.

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Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universittätsmedizin, Berlin, Germany.



Patients with acquired cold urticaria (ACU) show itchy wheals during cold exposure. This disturbing condition involves histamine and platelet-activating factor in its pathogenesis. Rupatadine is a dual antagonist of both histamine and platelet-activating factor.


To assess rupatadine efficacy in preventing reactions to cold challenge in patients with ACU.


A crossover, randomized, double-blind, placebo-controlled study in which 21 patients with ACU received rupatadine, 20 mg/d, or placebo for 1 week each is presented. The main outcome was the critical stimulation time threshold (CSTT) determined by ice cube challenge. Secondary outcomes included CSTT and the critical temperature threshold assessed by a cold provocation device (TempTest 3.0), as well as scores for wheal reactions, pruritus, burning sensations, and subjective complaints after cold challenge.


After rupatadine treatment, 11 (52%) of 21 patients exhibited a complete response (ie, no urticaria lesions after ice cube provocation). A significant improvement in CSTT compared with placebo was observed after ice cube and TempTest 3.0 challenge (P = .03 and P = .004, respectively). A significant reduction of critical temperature threshold (P < .001) and reduced scores for cold provocation-induced wheal reactions (P = .01), pruritus (P = .005), burning sensation (P = .03), and subjective complaints (P = .03) after rupatadine treatment were also found. Mild fatigue (n = 4), somnolence (n = 1), and moderate headache (n = 1) were reported during active treatment.


Rupatadine, 20 mg/d, shows high efficacy and is well tolerated in the treatment of ACU symptoms.

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