Efficacy and tolerability of moxifloxacin in 2338 patients with acute exacerbation of chronic bronchitis.

OBJECTIVE: A post-marketing surveillance (PMS) study was conducted to evaluate the efficacy and tolerability of moxifloxacin 400mg once daily in patients with acute exacerbation of chronic bronchitis (AECB) treated by pulmonologists and pulmonary specialists in community-based practice settings. PATIENT AND METHODS: 2338 patients with AECB (54% male; 46% female) were included in the analysis. PMS studies are prospective, open, uncontrolled and observational in design. All therapeutic decisions were made by the attending physician, based on their clinical practice and experience. This approach was adopted in order to provide valuable information on the safety and efficacy of moxifloxacin therapy in routine clinical practice.
RESULTS: The main symptoms of AECB (cough, expectoration, dyspnoea, chest pain and fever) were either resolved or improved in 80-97% of patients. Most patients (65%) improved within 3 days of starting moxifloxacin therapy and 91.6% by day 5. Mean time to improvement was 3.2±1.6 days. Overall, 96.1% of patients were judged by their physician to be either cured or improved following moxifloxacin therapy. Approximately 57% of patients had previously been treated with an antibiotic for their last episode of AECB. The antibiotics used were mostly macrolides (18.2% of patients), beta-lactams (16.9%), tetracycline/ doxycycline (9.9%) and quinolones (9.5%). The tolerability of moxifloxacin therapy was rated as 'very good' or 'good' in 95.4% of patients. Adverse events were reported in only 1.5% of patients.
CONCLUSION: In conclusion, moxifloxacin 400mg once daily was effective and well tolerated in this group of patients with AECB, combined with a rapid onset of action and a similarly high clinical success rate to that observed in controlled comparative clinical trials.