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

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 H 1-receptor antagonist, in patients w...

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Bibliographic Details
Published in:Journal of the American Academy of Dermatology 2003-04, Vol.48 (4), p.535-541
Main Authors: Monroe, Eugene, Finn, Albert, Patel, Piyush, Guerrero, Robinson, Ratner, Paul, Bernstein, David
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Adult
Allergic diseases
Biological and medical sciences
Child
Chronic Disease
Double-Blind Method
Drug Administration Schedule
Female
Histamine H1 Antagonists - administration & dosage
Histamine H1 Antagonists - adverse effects
Humans
Immunopathology
Loratadine - administration & dosage
Loratadine - adverse effects
Loratadine - analogs & derivatives
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Skin allergic diseases. Stinging insect allergies
Skin, nail, hair, dermoskeleton
Urticaria - drug therapy
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Summary: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 H 1-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.)
ISSN:0190-9622
1097-6787
DOI:10.1067/mjd.2003.143