Vol.57 No.S-2 July 2009
Clinical response of levofloxacin 500 mg qd to respiratory tract infection
1)Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, Japan
2)Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University
3)Department of Internal Medicine, Shinrakuen Hospital
4)Department of Clinical Infectious Diseases, School of Medicine, Showa University
5)Department of Internal Medicine 2, Oita University Faculty of Medicine
6)Department of Medicine and Therapeutics Control and Prevention of Infectious Diseases, Faculty of Medicine, University of the Ryukyus
7)Department of Laboratory Medicine, Nagasaki University Hospital
8)Department of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
9)Department of Pharmacology, Jikei University School of Medicine
Abstract
We evaluated the efficacy and safety of LVFX 500 mg qd administered for 7 days to 152 Japanese patients with respiratory tract infection in an open uncontrolled clinical study. We also studied the possible correlation of the incidence of adverse event and adverse drug reactions(ADRs) with individual pharmacokinetic (PK) parameters estimated by the Bayesian method.
Clinical efficacy was 95.1% (136/143 patients), and bacteriological efficacy 100% (45/45 patients). All causative organisms (50 strains), including those commonly separated, i.e., Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus, and Klebsiella pneumoniae, were eradicated with treatment in patients eligible for bacteriological efficacy assessment.
ADRs were reported in 60 patients at an incidence of 39.5%. A liver disorder was reported as a serious adverse drug reaction in a patient administered LVFX. The patient discontinued taking LVFX and recovered through hospitalization and medical treatment. No ADRs were severe and all had already been reported as LVFX ADRs.
Neither the incidence of adverse events nor ADRs was exposure-dependent in the LVFX plasma concentration range observed in this study.
In conclusion, LVFX 500 mg qd appears to have efficacy comparable or superior to that of the current standard dosage and presents no significant safety problem.
Key word
levofloxacin, respiratory tract infection, PK-PD, clinical study, once-a-day
Received
December 17, 2008
Accepted
March 23, 2009
Jpn. J. Chemother. 57 (S-2): 20-33, 2009
