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Efficacy and safety of garenoxacin tablets on bacterial pneumonia: Postmarketing surveillance in Japan


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Title: Efficacy and safety of garenoxacin tablets on bacterial pneumonia: Postmarketing surveillance in Japan
Authors: Izumikawa, Koichi / Watanabe, Akira / Miyashita, Naoyuki / Ishida, Tadashi / Hosono, Hiroaki / Kushimoto, Satoru / Kohno, Shigeru
Issue Date: Sep-2014
Publisher: 日本化学療法学会・日本感染症学会 / Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases
Citation: Journal of Infection and Chemotherapy, 20(9), pp.549-557; 2014
Abstract: We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent, garenoxacin (Geninax ® Tablets 200 mg), against bacterial pneumonia. Between October 2009 and March 2011, patients with community-acquired pneumonia visited 174 facilities in Japan; we collected survey forms from 739 patients of these patients who were suspected with bacterial pneumonia on the basis of factors, e.g., the presence of purulent sputum or suspected presence of bacterial pathogens in clinical specimens. We examined the safety in 730 patients and the efficacy in 535 patients. The efficacy rate of garenoxacin for bacterial pneumonia was 92.8% (479/516 patients). The eradication rates for Streptococcus pneumoniae and Haemophilus influenzae, the major pathogens of bacterial pneumonia, were 98.5% (65/66 strains) and 100% (65/65 strains), respectively. The incidence of adverse drug reactions (including abnormal laboratory tests) was 7.9% (58/730 patients). Among the main adverse drug reactions, abnormal laboratory tests were observed in 2.1% patients (15/730), hepatobiliary disorders were observed in 1.8% patients (13/730), and skin and subcutaneous tissue disorders were observed in 1.6% patients (12/730). In conclusion, garenoxacin showed an efficacy rate of greater than 90% for bacterial pneumonia and is considered to be useful in daily practice.
Keywords: Bacterial pneumonia / Clinical efficacy / Garenoxacin / Postmarketing surveillance / Safety
URI: http://hdl.handle.net/10069/34812
ISSN: 1341321X
DOI: 10.1016/j.jiac.2014.05.002
Rights: © 2014, Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved. / NOTICE: this is the author’s version of a work that was accepted for publication in Journal of Infection and Chemotherapy. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Journal of Infection and Chemotherapy, 20, 9, (2014)
Type: Journal Article
Text Version: author
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/34812

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