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Safety and Efficacy of Oral Fexofenadine in Children with Seasonal Allergic Rhinitis - a Pooled Analysis of Three Studies

2004-06Journal article Open access
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dc.contributor.authorMeltzer, E
dc.contributor.authorScheinmann, P
dc.contributor.authorRosado-Pinto, J
dc.contributor.authorBachert, C
dc.contributor.authorHedlin, G
dc.contributor.authorWahn, U
dc.contributor.authorFinn, A
dc.contributor.authorRuuth, E
dc.date.accessioned2016-06-21T09:34:29Z
dc.date.available2016-06-21T09:34:29Z
dc.date.issued2004-06
dc.description.abstractAllergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6-11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6-11 years.pt_PT
dc.identifier.citationPediatr Allergy Immunol. 2004 Jun;15(3):253-60.pt_PT
dc.identifier.doi10.1111/j.1399-3038.2004.00167.xpt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/2517
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBlackwell Munksgaardpt_PT
dc.subjectAnti-Allergic Agentspt_PT
dc.subjectChildpt_PT
dc.subjectDouble-Blind Methodpt_PT
dc.subjectFemalept_PT
dc.subjectHeadachept_PT
dc.subjectHistamine H1 Antagonistspt_PT
dc.subjectHumanspt_PT
dc.subjectMalept_PT
dc.subjectMeta-Analysis as Topicpt_PT
dc.subjectRhinitis, Allergic, Seasonalpt_PT
dc.subjectTerfenadinept_PT
dc.subjectTreatment Outcomept_PT
dc.subjectHDE ALERpt_PT
dc.titleSafety and Efficacy of Oral Fexofenadine in Children with Seasonal Allergic Rhinitis - a Pooled Analysis of Three Studiespt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage260pt_PT
oaire.citation.issue3pt_PT
oaire.citation.startPage253pt_PT
oaire.citation.titlePediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunologypt_PT
oaire.citation.volume15pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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