Abstract
Objective: We performed a multicentre study under a 2-year observational protocol that included data on time to recovery from acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) in patients receiving moxifloxacin and comparator antimicrobials.
Patients and methods: Outpatients with moderate or severe COPD were recruited from respiratory clinics throughout Spain. Moxifloxacin was available in year 2, and was to be prescribed to 50% of patients in that period in a non-randomised allocation. Time to recovery was compared in successfully treated AE-COPD; cross-sectionally for all AE-COPD over 2 years, first AE-COPD and all AE-COPD in year 2, and longitudinally in patients receiving comparator antimicrobials for AE-COPD in year 1 and moxifloxacin in year 2.
Results: 614 AE-COPD were treated in 441 patients over 2 years (mean age 66.7 8.3 years, 98% males, mean forced expiratory volume in 1 second [FEV1] 35.9 ± 8.8%). Mean time to recovery overall was 4.6 days (SD 3.3) with moxifloxacin 400 mg/day for 5 days, and 5.8 days (SD 4.6) with comparators (p < 0.01), which were most frequently amoxicillin/clavulanic acid 500/125mg/8h, clarithromycin 500mg/12h and cefuroxime axetil 500mg/12h for 7-10 days. Longitudinal analysis showed that 27 patients treated with moxifloxacin in the second year of the study recovered in a mean of 3.7 days (SD 3.1), and the same patients treated with comparator antimicrobials in year one recovered in a mean of 6.8 days (SD 4.6) [p = 0.02]. In contrast, in 66 patients treated with comparator antimicrobials in both years, mean time to recovery was 7.4 days (SD 7.3) in year one and 5.5 days (SD 3.5) in year two (p = 0.24). All subgroup analyses showed a statistically significant reduction of 18 25% in time to recovery with moxifloxacin compared with other antibiotics.
Conclusions: Moxifloxacin significantly reduced time to recovery from AE-COPD in patients with moderate to severe disease by approximately 20% (>1 day) compared with other antimicrobials. Faster recovery should result in earlier return to work or normal activities, and to social and economic savings.
Introduction
Chronic obstructive pulmonary disease (COPD) is often aggravated by intermittent acute exacerbations (AE-COPD) that are both costly and detrimental to the quality of life in patients.[1-3] Repeated epithelial insult and inflammation that accompany AE-COPD also contribute to the deterioration of lung function in smokers with COPD over time.[4] Antimicrobials have demonstrated significant benefit against AE-COPD and are currently the mainstay of symptomatic treatment.[5,6]
The adequate treatment of AE-COPD in Spain presents a challenge for several reasons, among which are the high prevalence of the disease and the increasing resistance of pathogens to routinely used antimicrobials.[7] Furthermore, antimicrobial treatment prescribed by general practitioners for AE-COPD in Spain in many cases does not comply with current guidelines.[8] With regard to drug resistance, a recent study of 300 isolates of Streptococcus pneumoniae in Spain showed 41% of the tested strains to be resistant to penicillin, and 36% to be resistant to macrolides (erythromycin).[9] At present, the global rates of resistance of respiratory tract pathogens to fluoroquinolones remain low.[10-12]
The recently introduced fluoroquinolone moxifloxacin is highly active against common respiratory tract pathogens and drug-resistant pneumococci when compared with other commercially available fluoroquinolones.[13-15] Moxifloxacin also provides coverage against atypical and anaerobic pathogens.[16,17] Moxifloxacin shows excellent respiratory tissue penetration as well as rapid initial killing and eradication rates for pneumococcal bacteria.[18,19] Observational studies and cross-sectional analyses in patients with chronic bronchitis and COPD suggest that this speed of action translates into faster recovery from symptoms of AE-COPD with moxifloxacin than with other commonly used treatments,[20-24] possibly faster bacteriological eradication,[25] and improved work productivity and cost savings.[26] The present study analysed time to recovery from AE-COPD with different antimicrobials used widely in general practice.
