tetano
Editor, Senior Moderator
Clin Infect Dis. 2016 Apr 26. pii: ciw255. [Epub ahead of print]
[h=1]Long-acting neuraminidase inhibitor laninamivir octanoate as post-exposure prophylaxis for influenza.[/h] Kashiwagi S[SUP]1[/SUP], Watanabe A[SUP]2[/SUP], Ikematsu H[SUP]1[/SUP], Uemori M[SUP]3[/SUP], Awamura S[SUP]4[/SUP]; Laninamivir Prophylaxis Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A single administration of laninamivir octanoate, a long-acting neuraminidase inhibitor, has been proven to be effective in the treatment of influenza, but not for post-exposure prophylaxis.
[h=4]METHODS:[/h] We conducted a double-blind, multicenter, randomized, placebo-controlled study to determine if a single administration of laninamivir octanoate 40 mg was superior to placebo for post-exposure prophylaxis. Eligible participants, who had cohabited with an influenza patient within 48 hours of symptom onset, were randomly assigned (1:1:1) to one of three groups: 40 mg of laninamivir octanoate single administration (LO-40SD), 20 mg of laninamivir octanoate once daily for two days (LO-20TD), or placebo. The primary efficacy endpoint was the proportion of participants who developed clinical influenza (defined as influenza virus positive, an axillary temperature exceeding 37.5?C and at least two symptoms) over a 10-day period.
[h=4]RESULTS:[/h] A total of 803 participants were enrolled, with 801 included in the primary analysis. The proportions of participants with clinical influenza were 4.5% (12/267), 4.5% (13/269), and 12.1% (32/265) in the LO-40SD, LO-20TD, and placebo groups, respectively. A single administration of laninamivir octanoate 40 mg significantly reduced the development of influenza compared with placebo (P=0.001). The relative risk reductions compared with the placebo group were 62.8% and 63.1% for the LO-40SD and LO-20TD groups, respectively. The incidence of adverse events in the LO-40SD group was similar to those of the LO-20TD and placebo groups.
[h=4]CONCLUSIONS:[/h] A single administration of laninamivir octanoate was effective and well tolerated as post-exposure prophylaxis to prevent the development of influenza.
? The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.
PMID: 27118785 [PubMed - as supplied by publisher]
[h=1]Long-acting neuraminidase inhibitor laninamivir octanoate as post-exposure prophylaxis for influenza.[/h] Kashiwagi S[SUP]1[/SUP], Watanabe A[SUP]2[/SUP], Ikematsu H[SUP]1[/SUP], Uemori M[SUP]3[/SUP], Awamura S[SUP]4[/SUP]; Laninamivir Prophylaxis Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A single administration of laninamivir octanoate, a long-acting neuraminidase inhibitor, has been proven to be effective in the treatment of influenza, but not for post-exposure prophylaxis.
[h=4]METHODS:[/h] We conducted a double-blind, multicenter, randomized, placebo-controlled study to determine if a single administration of laninamivir octanoate 40 mg was superior to placebo for post-exposure prophylaxis. Eligible participants, who had cohabited with an influenza patient within 48 hours of symptom onset, were randomly assigned (1:1:1) to one of three groups: 40 mg of laninamivir octanoate single administration (LO-40SD), 20 mg of laninamivir octanoate once daily for two days (LO-20TD), or placebo. The primary efficacy endpoint was the proportion of participants who developed clinical influenza (defined as influenza virus positive, an axillary temperature exceeding 37.5?C and at least two symptoms) over a 10-day period.
[h=4]RESULTS:[/h] A total of 803 participants were enrolled, with 801 included in the primary analysis. The proportions of participants with clinical influenza were 4.5% (12/267), 4.5% (13/269), and 12.1% (32/265) in the LO-40SD, LO-20TD, and placebo groups, respectively. A single administration of laninamivir octanoate 40 mg significantly reduced the development of influenza compared with placebo (P=0.001). The relative risk reductions compared with the placebo group were 62.8% and 63.1% for the LO-40SD and LO-20TD groups, respectively. The incidence of adverse events in the LO-40SD group was similar to those of the LO-20TD and placebo groups.
[h=4]CONCLUSIONS:[/h] A single administration of laninamivir octanoate was effective and well tolerated as post-exposure prophylaxis to prevent the development of influenza.
? The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.
PMID: 27118785 [PubMed - as supplied by publisher]