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Efficacy and safety of desloratadine in adults with chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, multicenter trial.
Am J Clin Dermatol. 2007; 8(1):37-42.AJ

Abstract

BACKGROUND AND OBJECTIVE

Chronic idiopathic urticaria (CIU), a condition characterized by pruritus and wheals, can cause patients physical and psychological distress. Desloratadine, a second-generation histamine H(1) receptor antagonist (antihistamine), is a first-line treatment option for CIU. The objective of this study was to evaluate the efficacy and safety of once-daily desloratadine 5mg versus placebo for the treatment of CIU symptoms and disease severity in adults.

METHODS

This was a randomized, placebo-controlled, multicenter trial of 137 adult patients with active CIU who received oral once-daily desloratadine 5mg or placebo for 6 weeks. Outcome measures included pruritus severity, number of wheals, and the size of the largest wheal. Patients assessed signs and symptoms on a four-point scale twice daily. The overall therapeutic response at the end of the 6-week treatment period was also rated.

RESULTS

Desloratadine treatment was associated with significant improvements compared with placebo in pruritus scores and in the size of the largest wheals as early as day 1. These improvements continued through to the end of the trial. The mean score for the number of wheals was significantly lower in the desloratadine group than in the placebo group on days 14 and 42 (p < or = 0.016). Overall improvement in CIU (complete, marked, or moderate therapeutic response) was also greater at the end of the study in the desloratadine group compared with placebo (p < 0.001). Adverse events occurred with similar frequency among desloratadine- and placebo-treated patients.

CONCLUSION

Once-daily desloratadine 5mg is well tolerated and superior to placebo in reducing pruritus and wheals associated with CIU. Desloratadine provided rapid and sustained relief of CIU symptoms as early as after the first dose and maintained this effect until the end of the 6-week treatment period.

Links

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Authors+Show Affiliations

Ortonne JP
Service de Dermatologie, Hôpital de l'Archet, Nice, France.
Grob JJ
No affiliation info available
Auquier P
No affiliation info available
Dreyfus I
No affiliation info available

MeSH

AdultChronic DiseaseDose-Response Relationship, DrugDouble-Blind MethodFemaleHistamine H1 Antagonists, Non-SedatingHumansLoratadineMaleMiddle AgedPruritusSeverity of Illness IndexTreatment OutcomeUrticaria

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17298105

Clinical Trial Links

Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

Citation

Ortonne, Jean-Paul, et al. "Efficacy and Safety of Desloratadine in Adults With Chronic Idiopathic Urticaria: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial." American Journal of Clinical Dermatology, vol. 8, no. 1, 2007, pp. 37-42.
Ortonne JP, Grob JJ, Auquier P, et al. Efficacy and safety of desloratadine in adults with chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, multicenter trial. Am J Clin Dermatol. 2007;8(1):37-42.
Ortonne, J. P., Grob, J. J., Auquier, P., & Dreyfus, I. (2007). Efficacy and safety of desloratadine in adults with chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, multicenter trial. American Journal of Clinical Dermatology, 8(1), 37-42.
Ortonne JP, et al. Efficacy and Safety of Desloratadine in Adults With Chronic Idiopathic Urticaria: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial. Am J Clin Dermatol. 2007;8(1):37-42. PubMed PMID: 17298105.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of desloratadine in adults with chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, multicenter trial. AU - Ortonne,Jean-Paul, AU - Grob,Jean-Jacques, AU - Auquier,Pascal, AU - Dreyfus,Isabelle, PY - 2007/2/15/pubmed PY - 2007/4/20/medline PY - 2007/2/15/entrez SP - 37 EP - 42 JF - American journal of clinical dermatology JO - Am J Clin Dermatol VL - 8 IS - 1 N2 - BACKGROUND AND OBJECTIVE: Chronic idiopathic urticaria (CIU), a condition characterized by pruritus and wheals, can cause patients physical and psychological distress. Desloratadine, a second-generation histamine H(1) receptor antagonist (antihistamine), is a first-line treatment option for CIU. The objective of this study was to evaluate the efficacy and safety of once-daily desloratadine 5mg versus placebo for the treatment of CIU symptoms and disease severity in adults. METHODS: This was a randomized, placebo-controlled, multicenter trial of 137 adult patients with active CIU who received oral once-daily desloratadine 5mg or placebo for 6 weeks. Outcome measures included pruritus severity, number of wheals, and the size of the largest wheal. Patients assessed signs and symptoms on a four-point scale twice daily. The overall therapeutic response at the end of the 6-week treatment period was also rated. RESULTS: Desloratadine treatment was associated with significant improvements compared with placebo in pruritus scores and in the size of the largest wheals as early as day 1. These improvements continued through to the end of the trial. The mean score for the number of wheals was significantly lower in the desloratadine group than in the placebo group on days 14 and 42 (p < or = 0.016). Overall improvement in CIU (complete, marked, or moderate therapeutic response) was also greater at the end of the study in the desloratadine group compared with placebo (p < 0.001). Adverse events occurred with similar frequency among desloratadine- and placebo-treated patients. CONCLUSION: Once-daily desloratadine 5mg is well tolerated and superior to placebo in reducing pruritus and wheals associated with CIU. Desloratadine provided rapid and sustained relief of CIU symptoms as early as after the first dose and maintained this effect until the end of the 6-week treatment period. SN - 1175-0561 UR - https://www.unboundmedicine.com/medline/citation/17298105/Efficacy_and_safety_of_desloratadine_in_adults_with_chronic_idiopathic_urticaria:_a_randomized_double_blind_placebo_controlled_multicenter_trial_ L2 - https://dx.doi.org/10.2165/00128071-200708010-00005 DB - PRIME DP - Unbound Medicine ER -