title: Efficacy and safety of garenoxacin tablets on bacterial pneumonia: postmarketing surveillance in Japan.
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.
authors.affiliation: Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. Electronic address: koizumik@nagasaki-u.ac.jp.
authors.forename: Koichi
authors.initials: K
authors.lastname: Izumikawa
authors.affiliation: Institute of Development, Aging and Cancer, Tohoku University Research Division for Development of Anti-Infective Agents, Sendai, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Watanabe
authors.affiliation: Department of General Internal Medicine 1, Kawasaki Medical School, Kurashiki, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Miyashita
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Data Science and Administration Department, Toyama Chemical Co., Ltd., Tokyo, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Hosono
authors.affiliation: Data Science and Administration Department, Toyama Chemical Co., Ltd., Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Kushimoto
authors.affiliation: Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kohno
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D017714:Community-Acquired Infections / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects*; D006192:Haemophilus Infections / Q000188:drug therapy / Q000382:microbiology; D006193:Haemophilus influenzae / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D007564:Japan; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D011008:Pneumococcal Infections / Q000188:drug therapy / Q000382:microbiology; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use; D013296:Streptococcus pneumoniae / Q000187:drug effects / Q000302:isolation & purification; D013607:Tablets
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D011804:Quinolines; D013607:Tablets; C419689:garenoxacin
keywords: Bacterial pneumonia; Clinical efficacy; Garenoxacin; Postmarketing surveillance; Safety