Document Detail


Randomized placebo-controlled trial comparing desloratadine and montelukast in monotherapy and desloratadine plus montelukast in combined therapy for chronic idiopathic urticaria.
MedLine Citation:
PMID:  15356567     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: H 1 -receptor antagonists are considered to be particularly effective in reducing pruritus, and they are therefore recommended as first-line treatment in patients with chronic idiopathic urticaria (CIU). Recently, antileukotriene receptors have been used in patients with CIU, either administered as monotherapy or combined with H 1 -receptor antagonists.
OBJECTIVE: We compared the clinical efficacy of 5 mg of desloratadine administered once daily either as monotherapy or combined with a leukotriene antagonist, 10 mg of montelukast daily, and 10 mg of montelukast administered daily as monotherapy for the treatment of patients affected by CIU with placebo.
METHODS: One hundred sixty patients aged 18 to 69 years (mean +/- SD, 43.9 +/- 13.4 years) with a history of moderate CIU were selected. A randomized, double-blind, double-dummy, placebo-controlled, parallel-group study design was used. Patients were treated with 5 mg of desloratadine once daily (n = 40), 10 mg of montelukast once daily (n = 40), 5 mg of desloratadine (n = 40) in the morning plus montelukast in the evening, or matched placebo (n = 40). Assessment of treatment efficacy was based on scores of daily cutaneous symptoms evaluated reflectively and instantaneously.
RESULTS: Only the group treated with desloratadine as monotherapy or as combined therapy concluded the whole study. Twenty-seven of the 40 patients in the montelukast group and 35 of the 40 patients in the placebo group discontinued the treatment. As reflective evaluation, all groups showed significant differences compared with the placebo group in terms of total symptom score, number of hives, and size of largest hive. In addition to the pruritus, only the groups treated with desloratadine as monotherapy or combined therapy showed significant differences compared with those receiving placebo, whereas there were no differences between the montelukast and placebo groups. Finally, no differences were found between the desloratadine group and the desloratadine plus montelukast group. The instantaneous evaluation demonstrated similar results regarding the desloratadine group and the desloratadine plus montelukast group versus the placebo group, whereas there were no significant differences between the group treated with montelukast alone and the placebo group for pruritus and size of largest hive. No differences were found between the group treated with desloratadine alone and the desloratadine plus montelukast group.
CONCLUSIONS: The results of this comparative study demonstrate that desloratadine is highly effective for the treatment of patients affected by CIU. In addition, the regular combined therapy of desloratadine plus montelukast does not seem to offer a substantial advantage with respect to desloratadine as monotherapy in patients affected by moderate CIU.
Authors:
Gabriele Di Lorenzo; Maria Luisa Pacor; Pasquale Mansueto; Maria Esposito Pellitteri; Claudia Lo Bianco; Vito Ditta; Nicola Martinelli; Giovam Battista Rini
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of allergy and clinical immunology     Volume:  114     ISSN:  0091-6749     ISO Abbreviation:  J. Allergy Clin. Immunol.     Publication Date:  2004 Sep 
Date Detail:
Created Date:  2004-09-09     Completed Date:  2004-10-20     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  1275002     Medline TA:  J Allergy Clin Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  619-25     Citation Subset:  AIM; IM    
Affiliation:
Dipartimento di Medicina Clinica e delle Patologie Emergenti, Università di Palermo, 90127 Palermo, Italy. dilo601@unipa.it
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MeSH Terms
Descriptor/Qualifier:
Acetates / administration & dosage,  therapeutic use*
Adolescent
Adult
Aged
Chronic Disease
Double-Blind Method
Female
Histamine H1 Antagonists, Non-Sedating / administration & dosage,  therapeutic use*
Humans
Leukotriene Antagonists / administration & dosage,  therapeutic use*
Loratadine / administration & dosage,  analogs & derivatives*,  therapeutic use*
Male
Middle Aged
Quinolines / administration & dosage,  therapeutic use*
Treatment Outcome
Urticaria / drug therapy*
Chemical
Reg. No./Substance:
0/Acetates; 0/Histamine H1 Antagonists, Non-Sedating; 0/Leukotriene Antagonists; 0/Quinolines; 79794-75-5/Loratadine; FVF865388R/desloratadine; MHM278SD3E/montelukast

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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