Short-course Fluoroquinolones in Acute Exacerbations of Chronic Bronchitis

Mark H Gotfried; Ronald F Grossman

Disclosures

Expert Rev Resp Med. 2010;4(5):661-672. 

In This Article

Comparative Studies on Speed of Recovery

An important consideration in the treatment of AECB is how quickly patients recover after initiation of antibiotic therapy. In this section, we review the clinical trials that evaluated the effects of short-course fluoroquinolones on the speed of recovery in AECB.

An open, community-based, observational study of 5737 patients with AECB enrolled by more than 2000 primary care physicians in Spain was conducted to examine the clinical outcomes of short-course moxifloxacin treatment (400 mg once daily for 5 days) over a 45-day period.[45] Clinical assessment was evaluated at 7 and 45 days after starting the therapy. Miravitlles and colleagues reported that 93.0% of patients treated with moxifloxacin were cured at day 7, and two-thirds of patients felt better by day 3 or 4. The authors suggested that once-daily moxifloxacin offered fast relief of symptoms of AECB.[45]

An observational nonrandomized study was carried out to compare late recovery and failure in 1147 patients with AECB who had been treated with co-amoxiclav 500 mg/125 mg three-times daily for 10 days, clarithromycin 500 mg twice daily for 10 days or moxifloxacin 400 mg once daily for 5 days.[46] The rate of failure at day 10 was 15.1%, without significant differences among the three antibiotic treatments. Median time to recovery was 5 days. Table 2 shows the effects of these antibiotic treatments on fast recovery (<5 days) and slow recovery (>5 days) from AECB.[46] Short-course, 5-day treatment with moxifloxacin was associated with faster recovery as compared with 10 days of co-amoxiclav or clarithromycin therapy; 70.3% of patients treated with moxifloxacin recovered in 5 days or less compared with 44.4% treated with co-amoxiclav or 49.7% with clarithromycin (p < 0.0001). The authors reported that moxifloxacin demonstrated a protective effect against late recovery compared with either co-amoxiclav (OR: 0.34; 95% CI: 0.26–0.45) and clarithromycin (OR: 0.41; 95% CI: 0.31–2.85).

Similar results have been reported by Miravitlles and colleagues in a multicenter 2-year observational study involving patients with acute exacerbations of COPD.[22] Patients with short-course moxifloxacin treatment had a shorter mean time to recovery overall (4.6 days) as compared with 5.8 days with standard therapy (co-amoxiclav 500/125 mg/8-h, clarithromycin 500 mg/12-h, or cefuroxime-axetil 500 mg/12-h for 7–10 days). In addition, the authors reported a statistically significant reduction of 18% in time to recovery with moxifloxacin compared with other antibiotics.[22]

A prospective, noninterventional, multicenter study was conducted to compare real-time treatment of AECB with moxifloxacin or macrolides in 1750 outpatients with AECB whose last exacerbation was treated with a macrolide. The current AECB was treated either with moxifloxacin (400 mg once daily) or with one of three macrolides (azithromycin, clarithromycin or roxithromycin).[47] Schaberg and colleagues reported that the mean duration until improvement was 3.2 days in patients treated with moxifloxacin and 4.5 days in those treated with macrolide, and the mean duration until cure of AECB was 6.2 days and 7.5 days, respectively.[47] Figure 2 shows recovery rates over the first 10 days of observation.[47] This study further confirmed that moxifloxacin treatment provides faster symptom relief and higher recovery rates than macrolide therapy, with comparable safety and tolerability profiles.[47]

Figure 2.

Recovery rate over the first 10 days of observation following antimicrobial treatment. Mean duration until recovery in patients treated with moxifloxacin was 6.2 days compared with 7.5 days in patients treated with macrolide. The difference of 1.3 days was statistically significant (p < 0.0001).
Reproduced with permission from [47].

Treatment outcomes of short-course moxifloxacin therapy were compared with those of macrolides (azithromycin, clarithromycin and roxithromycin) in an observational study in general practice settings.[48] Clinical efficacy was evaluated by physician assessment and patient's response to the Nottingham Health Profile questionnaire. The overall clinical response rates were reported to be 96% in all four regimens. However, when patients' daily evaluations of AECB-specific symptoms were analyzed, a faster response rate was observed in the moxifloxacin group, including faster resolution of fever, chest pain, shortness of breath and painful cough, as well as improvement of sputum color and decrease in sputum volume.[48]

The influence of antibiotic choice was studied in the Gemifloxacin Long term Outcomes in Bronchitis Exacerbations (GLOBE) study, a randomized, double-blind trial to investigate the time course for recovery of health status following an AECB.[49] Patients received gemifloxacin 320 mg once daily for 5 days (214 patients) or clarithromycin 500 mg twice daily for 7 days (224 patients). Health status was measured using the St George's Respiratory Questionnaire (SGRQ) scores at baseline and after 4, 12 and 26 weeks. SGRQ scores at first presentation of acute exacerbation were not significantly different between the two treatment groups (p > 0.7). There was a progressive widening of the difference between the two groups after treatment, and at 26 weeks the SGRQ score was 4.6 units (95% CI: 9.1–0.1) lower in the patients treated with gemifloxacin, suggesting that gemifloxacin may have a more significant impact on the recovery of health status in patients with AECB.[49]

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