Efficacy and safety of levofloxacin in the outpatient treatment of exacerbation of chronic obstructive pulmonary disease: levofloxacin 750 mg vs. levofloxacin 500 mg

Abstract

Introduction: Bacterial pathogens occur in 40-60% of COPD exacerbations requiring appropriate and timely antimicrobial therapy. Aim of the study:To compare efficacy and safety of oral levofloxacin 750 mg and levofloxacin 500 mg in the outpatient treatment of moderate bacterial exacerbations of COPD. Methods:We performed an observational, non-randomized, open-label study (a real life-study) including 63 COPD patients with moderate bacterial exacerbation after treatment failure with some first-line antibiotic. They were divided in two groups: Group 1, treated 7 days with levofloxacin 750 mg once a day, and Group 2, treated 10 days with levofloxacin 500 mg once a day. All study subjects had intermediate visits at 3, 5, and 7 days (Group 1) and at 3, 5, 7, and 10 days (Group 2) at which they were evaluated about the duration of symptoms and the side-effects of the drug. Relapse rates were registered during a 20 days follow-up period in the patients with remission of the symptoms. Results:We found high clinical success rate in both Group 1 and Group 2 (84.3% and 83.9%, respectively). The mean time for clinical remission in days was significantly shorter in the study subjects treated with levofloxacin 750 mg than in the study subjects treated with levofloxacin 500 mg (5.1 ± 1.6 vs. 6.9 ± 1.8; P = 0.0001). In both Group 1 and Group 2 during the treatment was registered similar incidence of mild side effects (12.5% vs. 12.9%; P = 0.961). Incidence of relapses over a 20-day following-up period was also similar in both examined groups (7.4% vs. 7.7%; P = 0.968). Conclusion:Our findings supported the use of levofloxacin 750 mg as an alternative antibiotic in the treatment of COPD exacerbations due to its high efficacy and good tolerability.