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Journal of the American Academy of Dermatology
Volume 48, n° 4
pages 535-541 (avril 2003)
Doi : 10.1067/mjd.2003.143
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, MDa, Albert Finn, MDb, Piyush Patel, MDc, Robinson Guerrero, MDd, Paul Ratner, MDe, David Bernstein, MD

Desloratadine Urticaria Study Group

Milwaukee, Wisconsin; Charleston, South Carolina; Mississauga, Ontario, Canada; Providencia-Santiago, Chile; San Antonio, Texas; and Cincinnati, Ohio 
From Advanced Healthcare, Milwaukeea; National Allergy, Asthma and Urticaria Center of Charlestonb; Medical Director, Allied Clinical Research, Mississaugac; Centro de Enfermedades Respiratorias y Dermatologicas, Providencia-Santiagod; Sylvana Research, San Antonioe; and Bernstein Allergy Group, Cincinnati.f 


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. (J Am Acad Dermatol 2003;48:535-41.)

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 *A list of all investigators and their sites is given at the end of the article.
 Supported by a grant from Schering-Plough Research Institute.
 Conflict of interest: None identified.
 Reprint requests: Eugene W. Monroe, MD, Advanced Healthcare, Milwaukee Medical Clinic, 3003 W Good Hope Rd, Milwaukee, WI 53209-0996. E-mail:
 0190-9622/2003/$30.00 + 0

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