A randomized double-blind controlled study of laninamivir compared with oseltamivir for the treatment of influenza in patients with chronic respiratory diseases.

Abstract

Influenza infection tends to be severe in patients with chronic underlying diseases. This study evaluated the efficacy and safety of laninamivir octanoate, an inhaled neuraminidase inhibitor, for the treatment of influenza patients with chronic respiratory diseases; we conducted a double-blind, randomized controlled trial to compare the efficacy and safety of laninamivir octanoate and oseltamivir for the treatment of influenza in these patients. A total of 203 patients aged ≥20 years were randomized to receive either laninamivir octanoate or oseltamivir. The primary efficacy endpoint was the time to illness alleviation. This study is registered with JapicCTI; the registration number is JapicCTI-090940. The full analysis set (FAS) included a total of 201 patients (laninamivir group, n = 101; oseltamivir group, n = 100). Most patients had underlying bronchial asthma and 170 patients were infected with influenza A(H1N1)2009. The median time to illness alleviation was 64.7 h in the laninamivir group and 59.7 h in the oseltamivir group, with a difference of 5.0 h between the two groups (95 % confidence interval, -13.6 to 16.1 h). No adverse events specific to laninamivir octanoate were observed, and adverse events such as bronchospasm, which has been reported to be observed with other inhaled drugs related to laninamivir octanoate, did not occur. Laninamivir octanoate showed similar efficacy and safety to oseltamivir in the treatment of influenza, including that caused by influenza A(H1N1)2009, in patients with chronic respiratory diseases.

• Authors: Akira Watanabe
• Journal: Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy (J Infect Chemother) Vol. 19 Issue 1 Pg. 89-97 (Feb 2013) ISSN: 1437-7780 [Electronic] Netherlands
• PMID: 22907567 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Enzyme Inhibitors
• Guanidines
• Pyrans
• Sialic Acids
• Oseltamivir
• laninamivir
• Neuraminidase
• Zanamivir

Topics

• Adult
• Aged
• Antiviral Agents (adverse effects, therapeutic use)
• Asthma (complications)
• Chronic Disease
• Double-Blind Method
• Enzyme Inhibitors (therapeutic use)
• Female
• Guanidines
• Humans
• Influenza A Virus, H1N1 Subtype (drug effects)
• Influenza, Human (drug therapy, virology)
• Male
• Middle Aged
• Neuraminidase (antagonists & inhibitors)
• Oseltamivir (adverse effects, therapeutic use)
• Pyrans
• Sialic Acids
• Treatment Outcome
• Zanamivir (adverse effects, analogs & derivatives, therapeutic use)