Safety of fexofenadine in children treated for seasonal allergic rhinitis

Graft, David F.; Bernstein, David I.; Goldsobel, Alan B.; Meltzer, Eli O.; Portnoy, Jay M.; Long, Joseph B.

doi:10.1016/s1081-1206(10)62317-4

Cited by 35 publications

(42 citation statements)

References 16 publications

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“…The results of this trial confirm previous findings in which fexofenadine HCl at doses of up to 60 mg bid are safe and nonsedating in children aged 6 to 11 years. 25 This finding is further supported by the results of dose-response trials in healthy individuals, in which doses of up to 690 mg bid for 1 month were found to be safe and well-tolerated. 39,40 Extensive studies in children and adults have also shown no effect of fexofenadine on QT c compared with placebo.…”

Section: Discussionmentioning

confidence: 70%

“…39,40 Extensive studies in children and adults have also shown no effect of fexofenadine on QT c compared with placebo. 24,25,41 The proven efficacy of fexofenadine, in combination with its nonsedating and nonimpairing profile, evident even at doses in excess of those recommended by the manufacturer, offers validation for its use in the treatment of all symptoms of allergic rhinitis in children and adults.…”

Section: Discussionmentioning

confidence: 99%

“…[20][21][22][23] Previous studies have shown that doses of fexofenadine HCl up to 60 mg 2 times per day (bid) are safe and well tolerated in children aged 6 through 11 years. 24,25 The present study was conducted to confirm the efficacy and safety of twice-daily dosing of fexofenadine HCl (30 mg bid) compared with placebo in the treatment of SAR in children.…”

mentioning

confidence: 97%

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Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis

Wahn¹,

Meltzer²,

Finn³

et al. 2003

Journal of Allergy and Clinical Immunology

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Background: This is the first prospective, randomized, doubleblind, placebo-controlled study showing statistical improvement of an H 1 -antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period. Objective: This randomized, placebo-controlled, parallelgroup, double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis. Methods: This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (±1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point.Results: Fexofenadine was significantly superior to placebo in the primary efficacy analysis (P ≤ .0001). Individual symptom scores showed statistically significant superiority compared with placebo (P < .05), including nasal congestion in the evening reflective assessment (P < .05). There was no significant difference in adverse events between fexofenadine and placebo, either overall or by causality.

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Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

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Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis

Wahn¹,

Meltzer²,

Finn³

et al. 2003

Journal of Allergy and Clinical Immunology

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“…In light of the outlined importance and impact that AR can have on children's QoL, and knowing that it may be associated with and contribute to potentially serious sequelae, including asthma, sinusitis, and otitis media (9), it is surprising that few studies have attempted to evaluate the treatment success in paediatric seasonal (SAR) and/or perennial (PAR) rhinitis with the newer generation antihistamines. A Pubmed/Medline search (http://www.ncbi.nlm.nih.gov/pubmed/) at the time of research revealed no paediatric studies in SAR published with desloratadine and only two published with fexofenadine (10, 11). The latter were of short‐term duration (2‐wk treatment period) and one of them reported only safety but not efficacy of the drug (11).…”

mentioning

confidence: 99%

Levocetirizine in children: evidenced efficacy and safety in a 6‐week randomized seasonal allergic rhinitis trial

Blic

Wahn

Billard

et al. 2005

Pediatric Allergy Immunology

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Studies evaluating newer antihistamines in children are few. Levocetirizine is a potent and highly selective H1-antihistamine with a proven efficacy in adults. Primary objective was to assess the efficacy of levocetirizine 5 mg once-daily in reducing seasonal allergic rhinitis (SAR) symptoms, as measured by Total Four Symptom Score (T4SS = sum of sneezing, rhinorrhea, nasal and ocular pruritus), over the first 2 wk of treatment. Efficacy over 4 and 6 wk of treatment, effect on nasal congestion and on health-related quality of life as measured by PRQLQ (Paediatric Rhinoconjunctivitis Quality of Life Questionnaire) were among the major secondary objectives. A double-blind, randomized, placebo-controlled study including 177 children with a documented SAR (to grass and/or weed) for at least a year and having a mean baseline T4SS > or = 6 (out of 12). Children evaluated daily the severity of T4SS and nasal congestion on a scale from 0 (absent) to 3 (severe). PRQLQ responses were assessed on a scale from 0 (not bothered) to 6 (extremely bothered) and analysed descriptively. Global evaluation of disease evolution judged by investigators, parents and children was made on a scale from 1 (marked worsening) to 7 (marked improvement). For the primary objective, levocetirizine was statistically highly superior to placebo with a difference in adjusted means of 1.29 (95% CI: 0.66-1.92) in favour of levocetirizine (p < 0.001). The effect of levocetirizine was almost twice that of placebo (94.1% relative improvement over placebo). Nasal congestion was improved with levocetirizine reaching maximum difference to placebo of 0.31 (p < 0.05), a relative improvement over placebo of 77.5%. PRQLQ scores at week 2 improved with levocetirizine more than with placebo (0.85 vs. 0.51, respectively) remaining larger after 4 and 6 wk of treatment. In the study, 84.3%, 80.9%, 80.9% of children had their disease evolution rated as slightly-to-markedly improved by, respectively, the investigators, the parents and children themselves. Incidence of treatment-emergent adverse events was similar in both groups (33.7% with levocetirizine; 30.7% with placebo). No child in the levocetirizine group discontinued treatment because of adverse events. The 6-wk duration of this study was longer than the usual 2-4-wk duration for similar studies and shows that levocetirizine controls SAR symptoms in children over the entire pollen season.

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“…35 A total of 875 children aged 6-11 years with SAR were assessed by AE reporting, ECGs, pre-and post-treatment laboratory panels and physical examinations. The incidence of AEs was similar in the fexofenadine and placebo groups and no dose-response effects were observed.…”

Section: Safety Of Fexofenadinementioning

confidence: 99%

Pediatric Allergic Rhinitis: Antihistamine Selection

Berger¹

2005

Clin Pediatr (Phila)

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Safety of fexofenadine in children treated for seasonal allergic rhinitis

Cited by 35 publications

References 16 publications

Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis

Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis

Levocetirizine in children: evidenced efficacy and safety in a 6‐week randomized seasonal allergic rhinitis trial

Pediatric Allergic Rhinitis: Antihistamine Selection

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