Real-Life Treatment of Acute Exacerbations of Chronic Bronchitis with Moxifloxacin or Macrolides

T. Schaberg; M. Möller; T. File; K. Stauch; H. Landen


Clin Drug Invest. 2006;26(12):733-744. 

In This Article

Abstract and Introduction

Objective: To compare the real-life treatment of acute exacerbations of chronic bronchitis (AECBs) using moxifloxacin tablets or one of the oral macrolides azithromycin, clarithromycin or roxithromycin in terms of symptom relief, time until improvement and cure, overall efficacy and tolerability.
Methods: This prospective, non-interventional, multicentre study included out- patients with AECB whose last exacerbation was treated with a macrolide. The current AECB was treated either with moxifloxacin or with one of the macrolides azithromycin, clarithromycin or roxithromycin. Data were obtained on the patient's characteristics, disease and treatment history, the course of the current AECB including time to improvement and cure, and the final assessments of efficacy and tolerability. All adverse events were recorded in patients treated with moxifloxacin; for patients receiving macrolides, only drug-related adverse events were reported.
Results: 464 physicians treated 904 patients with moxifloxacin and 846 patients with one of the macrolides. Age, sex and body mass index were well matched between the two treatment groups. However, more moxifloxacin than macrolide patients presented with a generally bad condition (62.8% vs 48.6%). About 42% of patients in both groups had had chronic bronchitis for 1-5 years, and about 27% for 5-10 years. The mean number of AECBs in the previous 12 months was 2.7 and 2.6, respectively. Moxifloxacin was administered to most patients for 5 (43.8%) or 7 days (42.4%). Patients in the macrolide group were treated in most cases with clarithromycin 500mg for 4–7 days, roxithromycin 300mg for 6–7 days or azithromycin 500mg for 3 days. Physicians assessed overall efficacy and tolerability as 'very good' or 'good' in 96.1% and 98.1%, respectively, of moxifloxacin-treated patients and in 67.5% and 91.7%, respectively, of macrolide-treated patients. The mean duration until improvement and cure of AECB was 3.2 days (± SD 1.5) and 6.2 days (± 2.6) in moxifloxacin-treated patients compared with 4.5 days (± 1.8) and 7.5 days (± 3.0) in macrolide-treated patients (p < 0.0001).
Conclusion: The results of this study conducted under real-life treatment conditions in patients with AECBs who were previously treated with a macrolide showed faster symptom relief and higher recovery rates with moxifloxacin compared with macrolides. The two treatment groups had comparably good safety and tolerability profiles.

Acute exacerbations of chronic bronchitis (AECBs) are characterised by increased frequency and severity of coughing, increased amount of sputum, sputum purulence, worsened chest congestion and dyspnoea.[1] Infections of the lower respiratory tract play a major role in the aetiology of these severe complications.[2] Some AECBs may be caused by viruses, but in around 50% of episodes, bacterial pathogens can be isolated from distal airways.[2]

Each AECB episode aggravates the underlying chronic obstructive pulmonary disease (COPD).[3,4,5] Therefore, AECBs have major implications in terms of healthcare costs and quality of life.[6] According to WHO data, about 2.75 million deaths per year are caused by COPD.[7] In Germany, 10–12% of the adult population is estimated to have chronic bronchitis.[8] Furthermore, chronic bronchial disease predisposes patients to more severe infections and is responsible for around 10% of hospital admissions in the US.[9]

Current guidelines generally recommend ß-lactams and macrolides for the treatment of AECBs.[10,11] However, most of the guidelines have not been updated since 2001 and therefore they do not take into account the new respiratory fluoroquinolones. The guidelines of the Global Initiative for Chronic Obstructive Lung Disease have, however, been updated recently, and these recommend use of the new respiratory fluoroquinolones for the treatment of patients with moderate, severe or very severe AECBs.[12] Similar recommendations have been published by the Canadian Thoracic Society/Canadian Infectious Disease Society,[13] the European Respiratory Society[14] and by the Paul-Ehrlich-Society of Chemotherapy, the German Respiratory Society, the German Society for Infectiology and the Competence Network CAPNETZ Germany.[15]

The broad antibacterial spectrum of the new respiratory fluoroquinolones should be especially advantageous in patients with advanced disease because, with deteriorating lung function, the bacterial pathogens responsible for AECB shift from staphylococci and pneumococci (in patients with moderately reduced lung function) to more problematic pathogens such as Haemophilus influenzae and Moraxellacatarrhalis (in patients with severely reduced lung function) and to very problematic bacteria such as Klebsiella pneumonia, Pseudomonas aeruginosa and Enterobacter spp. (in patients with very severely reduced lung function).[16] In the outpatient setting of our study the most commonly expected pathogen would be H . influenzae.

Moxifloxacin, an 8-methoxy-fluoroquinolone, has demonstrated rapid bactericidal activity against Gram-positive and Gram-negative pathogens and anaerobic bacteria involved in respiratory tract infections, including the atypical pathogens Chlamydia pneumoniae and Mycoplasma pneumoniae as well as ß-lactamase-producing H. influenzae and M.catarrhalis and penicillin- and macrolide-resistant pneumococci.[17,18,19,20] Moreover, penicillin-, cephalosporin- and macrolide-resistant strains, as well as ß-lactamase-producing strains, are fully sensitive to moxifloxacin.[21] The published susceptibility rates to moxifloxacin are 98.2–100% for Streptococcus pneumoniae and 100% for S . pyogenes, H . influenzae and K . pneumoniae.[22,23,24,25,26] Because of its broad antibacterial activity, moxifloxacin is a very interesting option for the treatment of AECBs.

As AECBs have an important role in the progressive deterioration of lung function, COPD patients benefit significantly from a highly effective antibacterial therapy that leads to a prolongation of symptom-free intervals.[27,28] In a large double-blind, controlled clinical study published in 2004, AECB patients treated with moxifloxacin showed a significantly longer exacerbation-free interval compared with patients treated with other antibacterials.[29] In previous post-marketing surveillance (PMS) studies conducted in a routine clinical practice population, treatment with moxifloxacin resulted in a rapid improvement in AECB signs and symptoms.[30,31]

The objective of the present PMS study was to investigate real-life treatment of AECBs with moxifloxacin in comparison with real-life treatment of AECBs with one of three different macrolides. Particular outcomes of interest were symptom relief, time until improvement and cure, and overall efficacy and tolerability.


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