title: Efficacy and safety of garenoxacin tablets on clinically diagnosed atypical 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 atypical pneumonia. Between October 2009 and July 2011, patients with community-acquired pneumonia visited 26 facilities in Japan; we collected survey forms from 105 of these patients who were suspected of having atypical pneumonia based on the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults. We examined the safety in 105 patients and the efficacy in 71 patients. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients) and 92.3% (12/13 patients), respectively. The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively. In conclusion, garenoxacin showed an efficacy rate of greater than 90% for suspected atypical pneumonia and confirmed atypical pneumonia. Garenoxacin is considered to be useful in daily practice.
authors.affiliation: Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, 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: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D023521:Chlamydophila Infections / Q000188:drug therapy / Q000382:microbiology; D016993:Chlamydophila pneumoniae / Q000187:drug effects / Q000302:isolation & purification; D017714:Community-Acquired Infections / Q000188:drug therapy; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D007564:Japan; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009177:Mycoplasma pneumoniae / Q000187:drug effects / Q000302:isolation & purification; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D011019:Pneumonia, Mycoplasma / Q000188:drug therapy / Q000382:microbiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use; D013607:Tablets
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D011804:Quinolines; D013607:Tablets; C419689:garenoxacin
keywords: Atypical pneumonia; Clinical efficacy; Garenoxacin; Postmarketing surveillance; Safety