Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study

Authors

  • Johannes Ring MD,

    1. From the Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein, Technische Universität München, München, Germany, Intermountain Clinical Research, Salt Lake City, Utah, and the Oregon Medical Research Center, Portland, Oregon
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  • Rüdiger Hein MD,

    1. From the Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein, Technische Universität München, München, Germany, Intermountain Clinical Research, Salt Lake City, Utah, and the Oregon Medical Research Center, Portland, Oregon
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  • Anke Gauger MD,

    1. From the Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein, Technische Universität München, München, Germany, Intermountain Clinical Research, Salt Lake City, Utah, and the Oregon Medical Research Center, Portland, Oregon
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  • Edwin Bronsky MD,

    1. From the Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein, Technische Universität München, München, Germany, Intermountain Clinical Research, Salt Lake City, Utah, and the Oregon Medical Research Center, Portland, Oregon
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  • Bruce Miller MD,

    1. From the Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein, Technische Universität München, München, Germany, Intermountain Clinical Research, Salt Lake City, Utah, and the Oregon Medical Research Center, Portland, Oregon
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  • and the Desloratadine Study Group

    1. From the Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein, Technische Universität München, München, Germany, Intermountain Clinical Research, Salt Lake City, Utah, and the Oregon Medical Research Center, Portland, Oregon
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  • *

    Investigators of the Desloratadine Urticaria Study Group: Johannes Ring (München, Germany), Debra Breneman (Cincinnati, OH), Edwin Bronsky (Salt Lake City, UT), Marcus Conneley (Hesperia, CA), Jonathan Corren (Los Angeles, CA), Jan Ceuppens (Leuven, Belgium), Gerhardt Fierlbeck (Tuebingen, Germany), Gilbert Friday (Pittsburgh, PA), Pinkus Goldberg (Indianapolis, IN), David Graft (Minneapolis, MN), Tormod Holst (Tonsberg, Norway), Richard Honsinger (Los Alamos, NM), Ann-Marie Hornmark (Orebro, Sweden), Harold Kaiser (Minneapolis, MN), Robert Kaplan (Memphis, TN), Steven Kempers (Fridley, MN), Richard Lockey (Tampa, FL), Bruce Miller (Portland, OR), S David Miller (N. Dartmouth, MA), Anjuli Nayak (Normal, IL), Nicholas Nayak (Normal, IL), David Pariser (Norfolk, VA), Bruce Prenner (San Diego, CA), Thomas Ruzicka (Düsseldorf, Germany), G Edward Stewart II (Ocala, FL), Mark Thompson (Torrance, CA), and Michael Wein (Vero Beach, FL).


Johannes Ring, md
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein
Technische Universität München
Biedersteinstrabe 29
80802 München
Germany

Abstract

Abstract

Background  Chronic idiopathic urticaria (CIU) is the most common type of chronic urticaria, and pruritus is the most prominent symptom. Antihistamines are the first-line treatment for CIU. Sedation and anticholinergic adverse effects are often experienced with the first-generation antihistamines and there is a risk of cardiovascular adverse effects and drug interactions with some second-generation agents. Hence, new treatment options are needed. Desloratadine is a new, potent, nonsedating antihistamine that has an excellent cardiovascular safety profile.

Methods  This was a multicenter, randomized, double-blind, placebo-controlled study designed to determine the efficacy and safety of desloratadine in the treatment of moderate-to-severe CIU. A total of 190 patients, aged 12–79 years, with at least a 6-week history of CIU and who were currently experiencing a flare of at least moderate severity, were randomly assigned to therapy with desloratadine 5 mg or placebo once daily for 6 weeks. Twice daily, patients rated the severity of CIU symptoms (pruritus, number of hives, and size of largest hive), as well as the impact of CIU symptoms on sleep and daily activity. Patients and investigators jointly evaluated therapeutic response and overall condition. Safety evaluations included the incidence of treatment-emergent adverse events, discontinuations due to adverse events, and changes from baseline in vital signs, laboratory parameters, and ECG intervals.

Results  Desloratadine was superior to placebo in controlling pruritus and total symptoms after the first dose and maintained this superiority to the end of the study. Measures of sleep, daily activity, therapeutic response, and global CIU status were also significantly better with desloratadine after the first dose; these clinical benefits were also maintained throughout the 6-week study. No significant adverse events occured.

Conclusions  Desloratadine 5 mg daily is a safe and effective treatment for CIU with significant benefits within 24 h and maintained through the treatment period.

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