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

Koichi Izumikawa, Akira Watanabe, Naoyuki Miyashita, Tadashi Ishida, Hiroaki Hosono, Satoru Kushimoto, Shigeru Kohno

    Research output: Contribution to journalArticle

    7 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)549-557
    Number of pages9
    JournalJournal of Infection and Chemotherapy
    Volume20
    Issue number9
    DOIs
    Publication statusPublished - 2014 Sep

    Keywords

    • Bacterial pneumonia
    • Clinical efficacy
    • Garenoxacin
    • Postmarketing surveillance
    • Safety

    ASJC Scopus subject areas

    • Microbiology (medical)
    • Pharmacology (medical)
    • Infectious Diseases

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  • Cite this

    Izumikawa, K., Watanabe, A., Miyashita, N., Ishida, T., Hosono, H., Kushimoto, S., & Kohno, S. (2014). Efficacy and safety of garenoxacin tablets on bacterial pneumonia: Postmarketing surveillance in Japan. Journal of Infection and Chemotherapy, 20(9), 549-557. https://doi.org/10.1016/j.jiac.2014.05.003