PMID- 25470818
OWN - NLM
STAT- MEDLINE
DCOM- 20160412
LR  - 20150721
IS  - 2040-2058 (Electronic)
IS  - 1359-6535 (Linking)
VI  - 20
IP  - 4
DP  - 2015
TI  - Evaluation of safety and efficacy of intravenous zanamivir in the treatment of 
      hospitalized Japanese patients with influenza: an open-label, single-arm study.
PG  - 415-23
LID - 10.3851/IMP2922 [doi]
AB  - BACKGROUND: Zanamivir is a neuraminidase (NA) inhibitor used for the treatment of 
      influenza. There is an unmet need for a parenteral influenza antiviral therapy to 
      treat hospitalized patients. Therefore the safety and efficacy profile of 
      intravenous zanamivir (IVZ) was examined in Japanese patients with severe 
      influenza. METHODS: The primary objective of this study was to evaluate the 
      safety of IVZ in Japanese patients. Clinical outcome and virological data were 
      also assessed as secondary measures. Patients hospitalized with influenza were 
      treated with IVZ 600 mg twice daily for five days. RESULTS: A total of 21 
      subjects received IVZ; 17 subjects (81%) were infected with influenza A/H3N2 and 
      3 (14%) were infected with influenza B. One subject was not laboratory confirmed 
      influenza-positive. Thirteen subjects received the first dose of IVZ within two 
      days of the onset of influenza symptoms and six subjects had been treated with 
      prior influenza antiviral therapy. Overall adverse events (AEs) and serious 
      adverse events (SAEs) were reported in 13 (62%) and 4 (19%) subjects, 
      respectively. There were no patterns of AEs or SAEs. Median time to clinical 
      response and time to virological improvement were approximately 4 days (range 
      0.5-22) and 3 days (range 2-5), respectively. CONCLUSIONS: In this study there 
      were no new significant safety findings or patterns of AEs related to IVZ and 
      therefore the safety profile was confirmed for a small sample of Japanese 
      hospitalized patients with influenza. In addition, improvements in clinical and 
      virological measures suggestive of the clinical usefulness were also observed. 
      ClinicalTrials.gov NCT01527110; GSK NAI115215.
FAU - Watanabe, Akira
AU  - Watanabe A
AD  - Research Division for Development of Anti-Infective Agents, Institute of 
      Development, Aging and Cancer, Tohoku University, Sendai, Japan. 
      akiwa@idac.tohoku.ac.jp.
FAU - Yates, Phillip J
AU  - Yates PJ
FAU - Murayama, Marie
AU  - Murayama M
FAU - Soutome, Toru
AU  - Soutome T
FAU - Furukawa, Hiroiku
AU  - Furukawa H
LA  - eng
SI  - ClinicalTrials.gov/NCT01527110
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141203
PL  - England
TA  - Antivir Ther
JT  - Antiviral therapy
JID - 9815705
RN  - 0 (Antiviral Agents)
RN  - 0 (Enzyme Inhibitors)
RN  - 0 (Viral Proteins)
RN  - EC 3.2.1.18 (Neuraminidase)
RN  - L6O3XI777I (Zanamivir)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/*therapeutic use
MH  - Drug Administration Schedule
MH  - Enzyme Inhibitors/*therapeutic use
MH  - Female
MH  - Humans
MH  - Influenza A Virus, H3N2 Subtype/drug effects/growth & development
MH  - Influenza B virus/drug effects/growth & development
MH  - Influenza, Human/*drug therapy/virology
MH  - Injections, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Neuraminidase/*metabolism
MH  - Patient Safety
MH  - Treatment Outcome
MH  - Viral Proteins/*antagonists & inhibitors/metabolism
MH  - Zanamivir/*therapeutic use
EDAT- 2014/12/04 06:00
MHDA- 2016/04/14 06:00
CRDT- 2014/12/04 06:00
PHST- 2014/11/14 00:00 [accepted]
PHST- 2014/12/04 06:00 [entrez]
PHST- 2014/12/04 06:00 [pubmed]
PHST- 2016/04/14 06:00 [medline]
AID - 10.3851/IMP2922 [doi]
PST - ppublish
SO  - Antivir Ther. 2015;20(4):415-23. doi: 10.3851/IMP2922. Epub 2014 Dec 3.