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, Albert Finn, Piyush Patel, Robinson Guerrero, Paul Ratner, David Bernstein, Robert M. Cohen, Constantine John Falliers, Albert F. Finn, Frank C. Hampel, Alan M. Heller, Patrick V. Perin, Michael S. Rowe, Tommy Chua Sim, D. Lee Miller, Robert E. Grubbe, William Berger, James Baker, Sharon Raimer, Regina HamlinWilliam Stricker, Julius H. Van Bavel, Alicia D. Bucko, Charles Lynde, Bill Moote, Mario Sanchez, Gordon L. Sussman, Johannes Ring, Gerhardt Fierlbeck, Thomas Ruzicka, Tormod Holst, Ann Marie Hornmark, Jan Ceuppens

Research output: Contribution to journalArticle

100 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)535-541
Number of pages7
JournalJournal of the American Academy of Dermatology
Volume48
Issue number4
DOIs
StatePublished - Apr 1 2003
Externally publishedYes

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Urticaria
Randomized Controlled Trials
Placebos
Safety
Therapeutics
Histamine H1 Receptors
desloratadine
Histamine Antagonists
Pruritus
Multicenter Studies
Sleep
Incidence

ASJC Scopus subject areas

  • Dermatology

Cite this

Efficacy and safety of desloratadine 5 mg once daily in the treatment of chronic idiopathic urticaria : A double-blind, randomized, placebo-controlled trial. / Monroe, Eugene; Finn, Albert; Patel, Piyush; Guerrero, Robinson; Ratner, Paul; Bernstein, David; Cohen, Robert M.; Falliers, Constantine John; Finn, Albert F.; Hampel, Frank C.; Heller, Alan M.; Perin, Patrick V.; Rowe, Michael S.; Sim, Tommy Chua; Miller, D. Lee; Grubbe, Robert E.; Berger, William; Baker, James; Raimer, Sharon; Hamlin, Regina; Stricker, William; Van Bavel, Julius H.; Bucko, Alicia D.; Lynde, Charles; Moote, Bill; Sanchez, Mario; Sussman, Gordon L.; Ring, Johannes; Fierlbeck, Gerhardt; Ruzicka, Thomas; Holst, Tormod; Hornmark, Ann Marie; Ceuppens, Jan.

In: Journal of the American Academy of Dermatology, Vol. 48, No. 4, 01.04.2003, p. 535-541.

Research output: Contribution to journalArticle

Monroe, E, Finn, A, Patel, P, Guerrero, R, Ratner, P, Bernstein, D, Cohen, RM, Falliers, CJ, Finn, AF, Hampel, FC, Heller, AM, Perin, PV, Rowe, MS, Sim, TC, Miller, DL, Grubbe, RE, Berger, W, Baker, J, Raimer, S, Hamlin, R, Stricker, W, Van Bavel, JH, Bucko, AD, Lynde, C, Moote, B, Sanchez, M, Sussman, GL, Ring, J, Fierlbeck, G, Ruzicka, T, Holst, T, Hornmark, AM & Ceuppens, J 2003, 'Efficacy and safety of desloratadine 5 mg once daily in the treatment of chronic idiopathic urticaria: A double-blind, randomized, placebo-controlled trial', Journal of the American Academy of Dermatology, vol. 48, no. 4, pp. 535-541. https://doi.org/10.1067/mjd.2003.143
Monroe, Eugene ; Finn, Albert ; Patel, Piyush ; Guerrero, Robinson ; Ratner, Paul ; Bernstein, David ; Cohen, Robert M. ; Falliers, Constantine John ; Finn, Albert F. ; Hampel, Frank C. ; Heller, Alan M. ; Perin, Patrick V. ; Rowe, Michael S. ; Sim, Tommy Chua ; Miller, D. Lee ; Grubbe, Robert E. ; Berger, William ; Baker, James ; Raimer, Sharon ; Hamlin, Regina ; Stricker, William ; Van Bavel, Julius H. ; Bucko, Alicia D. ; Lynde, Charles ; Moote, Bill ; Sanchez, Mario ; Sussman, Gordon L. ; Ring, Johannes ; Fierlbeck, Gerhardt ; Ruzicka, Thomas ; Holst, Tormod ; Hornmark, Ann Marie ; Ceuppens, Jan. / Efficacy and safety of desloratadine 5 mg once daily in the treatment of chronic idiopathic urticaria : A double-blind, randomized, placebo-controlled trial. In: Journal of the American Academy of Dermatology. 2003 ; Vol. 48, No. 4. pp. 535-541.
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AU - Monroe, Eugene

AU - Finn, Albert

AU - Patel, Piyush

AU - Guerrero, Robinson

AU - Ratner, Paul

AU - Bernstein, David

AU - Cohen, Robert M.

AU - Falliers, Constantine John

AU - Finn, Albert F.

AU - Hampel, Frank C.

AU - Heller, Alan M.

AU - Perin, Patrick V.

AU - Rowe, Michael S.

AU - Sim, Tommy Chua

AU - Miller, D. Lee

AU - Grubbe, Robert E.

AU - Berger, William

AU - Baker, James

AU - Raimer, Sharon

AU - Hamlin, Regina

AU - Stricker, William

AU - Van Bavel, Julius H.

AU - Bucko, Alicia D.

AU - Lynde, Charles

AU - Moote, Bill

AU - Sanchez, Mario

AU - Sussman, Gordon L.

AU - Ring, Johannes

AU - Fierlbeck, Gerhardt

AU - Ruzicka, Thomas

AU - Holst, Tormod

AU - Hornmark, Ann Marie

AU - Ceuppens, Jan

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N2 - 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.

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