Laninamivir octanoate for post-exposure prophylaxis of influenza in household contacts: A randomized double blind placebo controlled trial

Seizaburo Kashiwagi, Akira Watanabe, Hideyuki Ikematsu, Shinichiro Awamura, Takako Okamoto, Mitsutoshi Uemori, Katsuyasu Ishida

    Research output: Contribution to journalArticle

    21 Citations (Scopus)

    Abstract

    Laninamivir octanoate, a long-acting neuraminidase inhibitor, is an effective treatment for influenza. However, its effectiveness for the prevention of influenza has not yet been demonstrated. We conducted a double-blind, multicenter, randomized, placebo-controlled trial to determine whether laninamivir octanoate was superior to a placebo for post-exposure prophylaxis of influenza in household contacts. Eligible participants, who were household members who did not have influenza and were in contact with an influenza-infected index patient, were randomly assigned (1:1:1) to one of three groups: 20 mg of laninamivir octanoate once daily for 2 days (LO-2), 20 mg of laninamivir octanoate once daily for 3 days (LO-3), or a placebo. The primary endpoint was the proportion of participants who developed clinical influenza during a 10-day period. A total of 1711 participants were enrolled, and 1451 participants were included in the primary analysis. The proportion of participants with clinical influenza was 3.9 % (19/487) in the LO-2 group, 3.7 % (18/486) in the LO-3 group, and 16.9 % (81/478) in the placebo group (P < 0.001 for each of the laninamivir octanoate group). The relative risk reductions, compared with the placebo group, were 77.0 % [95 % confidence interval (CI) 62.7-85.8] and 78.1 % (95 % CI 64.1-86.7 %) for the LO-2 and LO-3 groups, respectively. The incidences of adverse events in the laninamivir octanoate groups were similar to that in the placebo group. The inhalation of 20 mg of laninamivir octanoate once daily for 2 or 3 days was well tolerated and effectively prevented the development of influenza in household contacts.

    Original languageEnglish
    Pages (from-to)740-749
    Number of pages10
    JournalJournal of Infection and Chemotherapy
    Volume19
    Issue number4
    DOIs
    Publication statusPublished - 2013 Aug

    Keywords

    • Household contact
    • Influenza
    • Laninamivir
    • Neuraminidase inhibitor
    • Post-exposure
    • Prophylaxis

    ASJC Scopus subject areas

    • Microbiology (medical)
    • Pharmacology (medical)
    • Infectious Diseases

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