Efficacy and safety of desloratadine 5 mg once daily in the treatment of chronic idiopathic urticaria: A double-blind, randomized, placebo-controlled trial

Eugene Monroe, Albert Finn, Piyush Patel, Robinson Guerrero, Paul Ratner, David Bernstein, Robert M. Cohen, Constantine John Falliers, Albert F. Finn, Frank C. Hampel, Alan M. Heller, Patrick V. Perin, Michael S. Rowe, Tommy Chua Sim, D. Lee Miller, Robert E. Grubbe, William Berger, James Baker, Sharon Raimer, Regina HamlinWilliam Stricker, Julius H. Van Bavel, Alicia D. Bucko, Charles Lynde, Bill Moote, Mario Sanchez, Gordon L. Sussman, Johannes Ring, Gerhardt Fierlbeck, Thomas Ruzicka, Tormod Holst, Ann Marie Hornmark, Jan Ceuppens

Research output: Contribution to journalArticle

100 Scopus citations

Abstract

Background: Chronic idiopathic urticaria (CIU) has a major impact on patient well-being. Antihistamines are the first-line treatment for CIU; however, some cause sedation. Objective: Our purpose was to study the efficacy and safety of desloratadine, 5 mg, a new H1-receptor antagonist, in patients with moderate to severe CIU. Methods: This study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial of 6 weeks' duration. Results: Compared with placebo, desloratadine significantly improved the total CIU symptom score as well as pruritus, the number of hives, and the size of the largest hive. Overall therapeutic response and global CIU status improved significantly with desloratadine; interference with sleep was reduced and the performance of daily activities improved. Statistically and clinically significant improvements were seen within the first 24 hours of treatment and were sustained throughout the full duration of the study. The incidence of adverse events, including somnolence, was similar in the desloratadine and placebo groups. Conclusion: Desloratadine is a well-tolerated and effective treatment of CIU.

Original languageEnglish (US)
Pages (from-to)535-541
Number of pages7
JournalJournal of the American Academy of Dermatology
Volume48
Issue number4
DOIs
StatePublished - Apr 1 2003
Externally publishedYes

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ASJC Scopus subject areas

  • Dermatology

Cite this

Monroe, E., Finn, A., Patel, P., Guerrero, R., Ratner, P., Bernstein, D., Cohen, R. M., Falliers, C. J., Finn, A. F., Hampel, F. C., Heller, A. M., Perin, P. V., Rowe, M. S., Sim, T. C., Miller, D. L., Grubbe, R. E., Berger, W., Baker, J., Raimer, S., ... Ceuppens, J. (2003). Efficacy and safety of desloratadine 5 mg once daily in the treatment of chronic idiopathic urticaria: A double-blind, randomized, placebo-controlled trial. Journal of the American Academy of Dermatology, 48(4), 535-541. https://doi.org/10.1067/mjd.2003.143