Impact of oseltamivir treatment on the incidence and course of acute otitis media in children with influenza

Objective: Acute otitis media (AOM) is the most common complication of pediatric influenza, and imposes a substantial health care burden. We examined the influence of oseltamivir treatment on the incidence and course of AOM in children with influenza. Methods: In the original study, 695 children 1-12 years who presented within 48 h of the onset of influenza-like symptoms were randomized to oseltamivir (2 mg/kg) or placebo given twice daily for 5 days. AOM was assessed at enrollment and days 3, 6 ( 1), 10 ( 2) and 28 ( 7). AOM was clinically diagnosed by the participating primary care provider, supported by tympanometry when possible. We performed a retrospective analysis of those participants with laboratory-confirmed influenza (LCI). Assessments included the incidence and clinical course of new AOM cases. Results: In all, 452 children had LCI; 217 received oseltamivir and 235 placebo. AOM was diagnosed on or after study day 3 at a significantly lower frequency in the oseltamivir versus placebo group (12.4% versus 21.7%; relative risk [RR]: 0.57 [95% CI: 0.37, 0.88], respectively). Treatment effects were greatest for children 1-2 years (RR = 0.42 [95% CI: 0.20, 0.89]) and 3-5 years (RR = 0.45 [95% CI: 0.19, 1.04]), in whom the incidence of AOM was highest. Conclusions: Oseltamivir treatment significantly reduces the emergence of new AOM infections in children with LCI; effects are most pronounced in those <5 years. Clinical trial number: WV15758. (C) 2010 Elsevier Ireland Ltd. All rights reserved.