Inhaled Laninamivir Octanoate as Prophylaxis for Influenza in Children
Takashi Nakano1, Naruhiko Ishiwada2, Tokuhito Sumitani3
1Department of Pediatrics, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan.
Insights
Inhaled laninamivir octanoate effectively prevents influenza in children under 10 years old. This study shows it significantly reduced influenza incidence compared to placebo in pediatric household contacts.
Area of Science:
- Virology
- Pediatric Infectious Diseases
- Pharmacology
Background:
- Laninamivir octanoate is an effective influenza treatment.
- Its efficacy for influenza prevention in children under 10 years old was previously unestablished.
Purpose of the Study:
- To evaluate inhaled laninamivir octanoate for influenza prophylaxis in pediatric household contacts.
- To compare its efficacy against a placebo in preventing influenza development.
Main Methods:
- A double-blind, randomized, placebo-controlled, multicenter study was conducted.
- Pediatric subjects (<10 years) in contact with influenza index cases received either 20 mg inhaled laninamivir octanoate or placebo.
- The primary endpoint was the development of clinical influenza within 10 days.
Main Results:
- 11% of subjects receiving laninamivir octanoate developed influenza versus 19% receiving placebo (P = .02).
- Laninamivir octanoate demonstrated a 45.8% relative risk reduction in influenza incidence.
- Adverse event incidence was comparable between the laninamivir octanoate and placebo groups.
Conclusions:
- A single 20-mg dose of inhaled laninamivir octanoate is effective for influenza prophylaxis.
- The drug was well-tolerated in the pediatric population studied.
Background:
A single 20-mg dose of inhaled laninamivir octanoate is an effective treatment of influenza. However, the efficacy of laninamivir octanoate for the prevention of influenza in children <10 years of age has not yet been established.
Methods:
We conducted a double-blind, multicenter, randomized, placebo-controlled study to determine whether the efficacy of a single 20-mg dose of inhaled laninamivir octanoate to prevent the development of influenza was superior to that of placebo as prophylaxis for influenza in pediatric (<10 years) household members of index cases. Eligible subjects without influenza, in contact with an influenza-infected index case living in the same household, were blindly randomly assigned in a 1:1 ratio to receive 20 mg of laninamivir octanoate or placebo. The primary end point was the proportion of subjects who developed clinical influenza during a 10-day period.
Results:
A total of 343 subjects were randomly assigned, with 341 subjects included in the full analysis set for the primary analysis. The proportions of subjects who developed clinical influenza were 11% (18/171) in the laninamivir octanoate group and 19% (33/170) in the placebo group (P = .02). The relative risk reduction was 45.8% (95% confidence interval, 7.5% to 68.2%). The incidence of adverse events was similar in both groups.
Conclusions:
A single 20-mg dose of inhaled laninamivir octanoate was effective and well tolerated as prophylaxis for influenza.
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