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 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.


CONCLUSIONS
Desloratadine is a well-tolerated and effective treatment of CIU.
Monroe
Eugene
E
Advanced Healthcare, Milwaukee Medical Clinic, WI 53209-0996, USA. emonroe@ah.com
Finn
Albert
A
Patel
Piyush
P
Guerrero
Robinson
R
Ratner
Paul
P
Bernstein
David
D
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D014581:Urticaria / Q000188:drug therapy*
D006634:Histamine H1 Antagonists; D017336:Loratadine; C121345:desloratadine