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Critical temperature threshold measurement for cold urticaria: a randomized controlled trial of H1-antihistamine dose escalation

Authors


  • Funding sources
    This study was funded in part by the Urticaria Network e.V. (UNEV) and in part by a grant from MSD, Germany.

  • Conflicts of interest
    M. Magerl is, or was recently, a speaker for Almirall, Essex Pharma and Jerini/Shire. P.S. is, or was recently, involved in clinical trials supported by Essex Pharma (now MSD) and has been compensated for educational lectures by Essex Pharma (now MSD), Novartis and Shire. M.K.C. has received honoraria for lectures or consulting from UCB Pharma, Glaxo Smith Kline, Aventis, FAES Pharma and Schering Plough. M. Maurer is, or was recently, a speaker and/or advisor for Almirall Hermal, Bayer Schering Pharma, Biofrontera, Essex Pharma, Genentech, JADO Technologies, Jerini, Merckle Recordati, Novartis, Sanofi Aventis, Schering-Plough, Leo, MSD, Merck, Shire, Symbiopharm, UCB and Uriach. D.P. and P.M. declare no conflicts of interest. None of the authors has patents or commercial interests in products in development or marketed products to declare.

  • M. Magerl and D. Pisarevskaja contributed equally to this work.

Martin K. Church.
E-mail: mkc@soton.ac.uk

Abstract

Summary Background  Cold urticaria is a rare but severe and potentially lethal condition. It is primarily treated symptomatically with H1-antihistamines. However, patients have a variable response to these drugs and, to date, it has not been possible to predict readily the response to therapy of individual patients.

Objectives  To assess the severity of the cold urticaria in naive patients and the response to therapy of patients treated with increasing doses of an H1-antihistamine by measurement of critical temperature thresholds (CTT) for producing weals on the forearm.

Methods  This was a two-centre, hospital-based, double-blind, randomized, parallel-group study of patients with a confirmed diagnosis of cold urticaria of at least 6 months’ duration. Patient groups received either a constant dose of desloratadine 5 mg daily for 6 weeks (= 13), or escalating doses of desloratadine: 5 mg daily for the first 2 weeks, 10 mg daily for the second 2 weeks and 20 mg daily for the final 2 weeks (= 15). Only one adverse event that appeared to be drug related was reported: mild fatigue after treatment with desloratadine 10 mg that lasted for about 3 weeks and resolved at the end of the study.

Results  The desloratadine 5 mg daily dose produced a submaximal reduction of mean CTT which remained relatively constant over 6 weeks. Dose escalation increased efficacy, the reduction in mean CTT at four-times the standard daily dose being significantly greater (= 0·03) than with the standard dose. Individually, no patient became symptom free (CTT < 4 °C) on 5 mg, while two became symptom free on 10 mg and a further three on 20 mg desloratadine daily.

Conclusions  Measurement of CTT allows for individualized risk management and therapy in patients with cold urticaria.

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