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Oral oseltamivir treatment of influenza in children
R J Whitley1, F G Hayden, K S Reisinger
1University of Alabama, Birmingham, USA. rwhitley@peds.uab.edu
Insights
Oseltamivir effectively treats influenza in children, reducing illness duration by 26% and lowering otitis media incidence. This well-tolerated antiviral medication is recommended within 48 hours of symptom onset.
Area of Science:
- Pediatric Infectious Diseases
- Antiviral Therapeutics
- Influenza Management
Background:
- Influenza is a significant respiratory illness in children.
- Oral oseltamivir is an established influenza treatment for adults.
- Pediatric influenza treatment efficacy and safety require specific evaluation.
Purpose of the Study:
- To assess the efficacy and safety of oseltamivir in pediatric influenza patients.
- To determine the tolerability of oseltamivir in children aged 1-12 years.
- To evaluate oseltamivir's impact on illness duration and complications.
Main Methods:
- Randomized, double-blind, placebo-controlled trial.
- Involved children aged 1-12 years with influenza symptoms onset <48 hours.
- Oseltamivir (2 mg/kg/dose) or placebo administered twice daily for 5 days.
Main Results:
- Oseltamivir reduced median illness duration by 36 hours (26%) compared to placebo (P < 0.0001).
- Treatment decreased cough, coryza, fever duration, and otitis media diagnoses by 44%.
- Oseltamivir was well-tolerated, with a 5.8% incidence of emesis; adverse event discontinuation was low.
Conclusions:
- Oral oseltamivir is an effective and well-tolerated treatment for influenza in children.
- Early administration (within 48 hours of onset) is crucial for efficacy.
- Oseltamivir therapy reduces influenza-related complications and antibiotic use in children.
Background:
Oral oseltamivir administration is effective treatment for influenza in adults. This study was conducted to determine the efficacy, safety and tolerability of oseltamivir in children with influenza.
Methods:
In this randomized, double blind, placebo-controlled study, children 1 through 12 years with fever [> or =100 degrees F (> or =38 degrees C)] and a history of cough or coryza <48 h duration received oseltamivir 2 mg/kg/dose or placebo twice daily for 5 days. The primary efficacy endpoint was the time to resolution of illness including mild/absent cough and coryza mild/absent, return to normal activity and euthermia.
Results:
Of 695 enrolled children 452 (65%) had influenza (placebo, n = 235; oseltamivir, n = 217). Among infected children the median duration of illness was reduced by 36 h (26%) in oseltamivir compared with placebo recipients (101 h; 95% confidence interval, 89 to 118 vs. 137 h; 95% confidence interval, 125 to 150; P < 0.0001). Oseltamivir treatment also reduced cough, coryza and duration of fever. New diagnoses of otitis media were reduced by 44% (12% vs. 21%). The incidence of physician-prescribed antibiotics was significantly lower in influenza-infected oseltamivir (68 of 217, 31%) than placebo (97 of 235, 41%; P = 0.03) recipients. Oseltamivir therapy was generally well-tolerated, although associated with an excess frequency of emesis (5.8%). Discontinuation because of adverse events was low in both groups (1.8% with oseltamivir vs. 1.1% with placebo). Oseltamivir treatment did not affect the influenza-specific antibody response.
Conclusions:
Oral oseltamivir administration is an efficacious and well-tolerated therapy for influenza in children when given within 48 h of onset of illness.