Vol.56 No.1 January 2008
Clinical evaluation of levofloxacin versus oral β-lactams for acute exacerbation of COPD
1)Department of Respiratory Medicine, Hokusyo Central Hospital, 299 Akasakamen, Emukai, Kitamatsuura, Nagasaki,Japan
2)Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University
3)Department of Respiratory Medicine, Shinrakuen Hospital
4)Department of Clinical Infectious Diseases, School of Medicine, Showa University
5)Division of Molecular & Clinical Microbiology, Department of Molecular Microbiology & Immunology, Nagasaki University Graduate School of Biomedical Sciences
Abstract
The NICE study suggested that there are approximately 5.3 million patients with chronic obstructive pulmonary disease (COPD) in Japan. Therefore, morbidity due to COPD is also high in Japan as it is in the USA and Europe. However, the presence of COPD has not been detected in the majority of these potential Japanese patients, and there are only about 0.2 million patients with a diagnosis of COPD in Japan.
The Japanese treatment guidelines for COPD recommend oral therapy with new quinolones or β-lactams. We conducted the present study to compare the efficacy of a new quinolone (levofloxacin: LVFX) with that of β-lactams for the treatment of patients with acute exacerbation of COPD on an outpatient basis.
There were 249 patients evaluable for clinical efficacy, comprising 191 treated with LVFX and 58 treated with β-lactam therapy. Efficacy was noted in 81.2% (155/191 patients) of the LVFX group versus 48.3% (28/58 patients) of the β-lactam group, with the efficacy rate being significantly higher in the LVFX group. The improvement rates for sputum volume, sputum color, and cough were all significantly higher in the LVFX group than in the β-lactam group. Regarding the improvement of QOL, the efficacy rate achieved with LVFX was also significantly higher than that obtained with β-lactams. In 10.5% (20/191 patients) of the LVFX group and 22.4% (13/58 patients) of the β-lactam group, another treatment was requested due to lack of improvement of symptoms caused by the exacerbation of COPD, and the readmission rate was significantly lower in the LVFX group.
Causative bacteria were isolated in 40.0% (32/80). The most frequent isolates were Streptococcus pneumoniae (8.8%), Haemophilus influenzae (10.0%), and Moraxella catarrhalis (15.0%). Among the atypical bacteria, Mycoplasma pneumoniae was detected in 1.1% (1/95), while Chlamydia pneumoniae was not detected (0/95 patients). Influenza virus, adenovirus, and respiratory syncytial(RS) virus were found in 9.0% (8/89), 1.2% (1/83), and 1.2% (1/83) of the patients, respectively.
The incidence of adverse drug reactions was 2.4% (7/296) in the LVFX group and 4.5% (4/88) in the β-lactam group. None of the patients experienced serious adverse drug reactions. Although about a half of the present subjects were very elderly (≥75 years old), the incidence of adverse reactions was not increased in the elderly subgroups receiving either LVFX or β-lactam therapy.
These results suggest that LVFX, which exhibits strong antibacterial activity and effectively penetrates the sputum, may be the treatment of choice for Japanese patients with exacerbation of COPD.
Key word
COPD, levofloxacin, β-lactam, efficacy, safety
Received
October 4, 2007
Accepted
November 29, 2007
Jpn. J. Chemother. 56 (1): 33-48, 2008