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Randomized Controlled Trial
. 2010 Jun;54(6):2575-82.
doi: 10.1128/AAC.01755-09. Epub 2010 Apr 5.

Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection

Norio Sugaya  1 , Yasuo Ohashi
Affiliations
Randomized Controlled Trial

Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection

Norio Sugaya et al. Antimicrob Agents Chemother. 2010 Jun.

Abstract

We conducted a double-blind, randomized controlled trial to compare a long-acting neuraminidase inhibitor, laninamivir octanoate, with oseltamivir. Eligible patients were children 9 years of age and under who had febrile influenza symptoms of no more than 36-h duration. Patients were randomized to 1 of 3 treatment groups: a group given 40 mg laninamivir (40-mg group), a group given 20 mg laninamivir (20-mg group), and an oseltamivir group. Laninamivir octanoate was administered as a single inhalation. Oseltamivir (2 mg/kg of body weight) was administered orally twice daily for 5 days. The primary end point was the time to alleviation of influenza illness. The primary analysis included 184 patients (61, 61, and 62 in the 40-mg group, 20-mg group, and oseltamivir group, respectively). Laninamivir octanoate markedly reduced the median time to illness alleviation in comparison with oseltamivir in patients infected with oseltamivir-resistant influenza A (H1N1) virus, and the reductions were 60.9 h for the 40-mg group and 66.2 h for the 20-mg group. On the other hand, there were no significant differences in the times to alleviation of illness between the laninamivir groups and oseltamivir group for patients with influenza A (H3N2) or B virus infection. Laninamivir octanoate was well tolerated. The most common adverse events were gastrointestinal events. Laninamivir octanoate was an effective and well-tolerated treatment for children with oseltamivir-resistant influenza A (H1N1) virus infection. Further study will be needed to confirm clinical efficacy against influenza A (H3N2) or B virus infection. Its ease of administration is noteworthy, because a single inhalation is required during the course of illness.

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Figures

FIG. 1.
FIG. 1.
Patient flow chart. *, did not complete inhalation of the test drug, and there were no postrandomization data; †, received both active drugs; this patient was analyzed as a member of the original treatment group in the full analysis set (FAS) and safety analysis set, but was excluded from the per protocol set (PPS).
FIG. 2.
FIG. 2.
Times to alleviation of influenza illness in patients included in the full analysis set.
See this image and copyright information in PMC

References

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