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Safety of desloratadine syrup in children.
Curr Med Res Opin. 2004 Dec; 20(12):1959-65.CM

Abstract

BACKGROUND

Allergic rhinitis (AR) and acute urticaria are common childhood maladies. Typically, the firstline treatment options for both include non-sedating antihistamines. First-generation antihistamines, such as diphenhydramine and hydroxyzine, although useful, cause sedation. Desloratadine, an oral non-sedating antihistamine, has been shown in multiple studies to be safe and effective in relieving the symptoms of AR and chronic idiopathic urticaria (CIU) in adults and adolescents.

OBJECTIVE AND METHODS

The current double-blind, placebo-controlled, parallel-group, single-center studies were undertaken to determine the safety and tolerability of desloratadine syrup in children aged 2 years-11 years with AR or CIU. Over 14 days, subjects aged 2 years-5 years were randomly assigned to receive once a day either 1.25 mg of desloratadine syrup (0.5 mg/mL) or matching placebo, and subjects aged 6 years-11 years were randomly assigned to receive once a day either 2.5 mg of desloratadine syrup or matching placebo. Safety evaluations included adverse event report collection, monitoring of vital signs, clinical laboratory measurements, and standard 12-lead electrocardiogram (ECG) measurements.

RESULTS

In the study involving subjects aged 2 years-5 years (n = 111), the incidence of adverse events was 7/55 for the group treated with desloratadine and 6/56 for placebo. In the study involving subjects aged 6 years-11 years (n = 120), the incidence of adverse events was 1/60 for the group treated with desloratadine and 6/60 for placebo. No severe or serious adverse events occurred, and no clinically relevant changes were noted in median clinical laboratory test values or mean vital signs in either group. ECG results from both age groups demonstrated no significant changes (p = NS) in mean ventricular rate or PR, QRS, or QT. No subjects had a Fridericia QT(c) interval > 440 ms at day 8 or day 15.

CONCLUSION

These studies demonstrate the safety of desloratadine syrup in children aged 2 years-11 years with AR or CIU.

Authors+Show Affiliations

Bloom M
Schering-Plough Research Institute, Kenilworth, New Jersey 07033, USA. melvyn.bloom@spcorp.com
Staudinger H
No affiliation info available
Herron J
No affiliation info available

MeSH

Acute DiseaseAdministration, OralChildChild, PreschoolDouble-Blind MethodElectrocardiographyFemaleHistamine H1 Antagonists, Non-SedatingHumansLoratadineMalePlacebosRhinitis, Allergic, PerennialRhinitis, Allergic, SeasonalUrticaria

Pub Type(s)

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

Language

eng

PubMed ID

15701213

Citation

Bloom, Melvyn, et al. "Safety of Desloratadine Syrup in Children." Current Medical Research and Opinion, vol. 20, no. 12, 2004, pp. 1959-65.
Bloom M, Staudinger H, Herron J. Safety of desloratadine syrup in children. Curr Med Res Opin. 2004;20(12):1959-65.
Bloom, M., Staudinger, H., & Herron, J. (2004). Safety of desloratadine syrup in children. Current Medical Research and Opinion, 20(12), 1959-65.
Bloom M, Staudinger H, Herron J. Safety of Desloratadine Syrup in Children. Curr Med Res Opin. 2004;20(12):1959-65. PubMed PMID: 15701213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of desloratadine syrup in children. AU - Bloom,Melvyn, AU - Staudinger,Heribert, AU - Herron,Jerry, PY - 2005/2/11/pubmed PY - 2005/4/20/medline PY - 2005/2/11/entrez SP - 1959 EP - 65 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 20 IS - 12 N2 - BACKGROUND: Allergic rhinitis (AR) and acute urticaria are common childhood maladies. Typically, the firstline treatment options for both include non-sedating antihistamines. First-generation antihistamines, such as diphenhydramine and hydroxyzine, although useful, cause sedation. Desloratadine, an oral non-sedating antihistamine, has been shown in multiple studies to be safe and effective in relieving the symptoms of AR and chronic idiopathic urticaria (CIU) in adults and adolescents. OBJECTIVE AND METHODS: The current double-blind, placebo-controlled, parallel-group, single-center studies were undertaken to determine the safety and tolerability of desloratadine syrup in children aged 2 years-11 years with AR or CIU. Over 14 days, subjects aged 2 years-5 years were randomly assigned to receive once a day either 1.25 mg of desloratadine syrup (0.5 mg/mL) or matching placebo, and subjects aged 6 years-11 years were randomly assigned to receive once a day either 2.5 mg of desloratadine syrup or matching placebo. Safety evaluations included adverse event report collection, monitoring of vital signs, clinical laboratory measurements, and standard 12-lead electrocardiogram (ECG) measurements. RESULTS: In the study involving subjects aged 2 years-5 years (n = 111), the incidence of adverse events was 7/55 for the group treated with desloratadine and 6/56 for placebo. In the study involving subjects aged 6 years-11 years (n = 120), the incidence of adverse events was 1/60 for the group treated with desloratadine and 6/60 for placebo. No severe or serious adverse events occurred, and no clinically relevant changes were noted in median clinical laboratory test values or mean vital signs in either group. ECG results from both age groups demonstrated no significant changes (p = NS) in mean ventricular rate or PR, QRS, or QT. No subjects had a Fridericia QT(c) interval > 440 ms at day 8 or day 15. CONCLUSION: These studies demonstrate the safety of desloratadine syrup in children aged 2 years-11 years with AR or CIU. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/15701213/Safety_of_desloratadine_syrup_in_children_ DB - PRIME DP - Unbound Medicine ER -