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Real-life Treatment of Acute Exacerbation of Chronic Bronchitis: Presented at ECCMID

By Chris Berrie

NICE, FRANCE -- April 6, 2006 -- Under the real-life treatment conditions of a physician's practice, moxifloxacin promotes faster symptom relief and higher recovery rates than other macrolides for patients with acute exacerbation of chronic bronchitis (AECB), according to a multicenter, open, prospective, non-interventional, non-randomized, observational study.

Kathrin Stauch, project manager, Medical Science Europe and Overseas, Postmarketing Surveillance Department, Bayer HealthCare, Leverkusen, Germany, presented the data on the 8-methoxyfluoroquinolone moxifloxacin here on April 3^rd at the 16^th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

AECB is known to be one of the main components in chronic obstructive pulmonary disease (COPD). There are some 3 million deaths per year caused by COPD and just over 10% of the population in Germany have chronic bronchitis.

The objectives of this study were to compare the real-life treatment of AECB using moxifloxacin tablets or different oral macrolides, in terms of symptom relief, time to improvement/cure, and overall efficacy and tolerability.

The researchers enrolled 464 general practice physicians throughout Germany, who were asked to record patient demographic and medical history, antibiotic treatments, severity of acute infection, and antibiotic therapy. To have a comparable baseline, patients were required to have had a macrolide agent as treatment for their most recent exacerbation of COPD.

Across the moxifloxacin (n = 904) and total macrolides (n = 846) groups, patients' demographic characteristics were similar for, respectively: mean age, 57.4 versus 56.4 years; males, 56.4% versus 54.7%; mean body mass index (BMI), 26.6 versus 26.7 kg/m²; current smokers, 27.7% versus 29.8%. Duration of chronic bronchitis and concomitant diseases were similar in the two treatment groups.

Patients were treated with either moxifloxacin tablets (400 mg OD) or the oral macrolides: azithromycin (n = 222; 500 mg OD in 85.1%), clarithromycin (n = 360; 500 mg OD in 71.7%) or roxithromycin (n = 264; 300 mg OD in 92%). The recommended course lengths for each of these agents were generally followed, with 5 to 10 day courses for moxifloxacin (97.7%), clarithromycin (79.5%) and roxithromycin (95.0%), and the shorter 3-5-day course for azithromycin (86.9%).

Subjective physician assessment of disease severity was significantly worse (P <.0001) for the moxifloxacin group than the macrolides group, respectively (mild, 4.8% vs. 8.4%; moderate, 35.7% vs. 44.3%; distinct, 48.2% vs. 39.1%; severe, 9.7% vs. 5.9%).

Time to improvement of acute exacerbation was significantly better with moxifloxacin (3.2 days) than macrolide (4.4 days; P <.0001). This was paralleled in the mean times to recovery of 6.2 days and 7.5 days, respectively (P <.0001). Total recovery rates were also significantly better with moxifloxacin than the macrolides (fever, 96.6% vs. 91.2%, P <.0001; dyspnoea, 69.0% vs. 60.2%, P =.0002; cough, 42.5% vs. 33.1%, P <.0001). Remission from purulent sputum was not significantly different between the drug treatments (98.9% vs. 98.8%, respectively).

Although largely subjective, physicians were also asked to provide their assessments of overall efficacies and tolerabilities. Moxifloxacin was rated better than the macrolides in terms of overall efficacy (96.1% vs. 67.5%) and overall tolerability (98.1% vs. 91.7%).

With no serious adverse effects reported for either group, the two treatments showed similar adverse reactions, which were restricted to gastrointestinal disorders.

This physician-based study comparing moxifloxacin and other macrolides thus indicates that in the treatment of patients with AECB, moxifloxacin shows superiority for symptom relief and recovery rates, with comparable safety profiles.

"We saw that physicians tended to use moxifloxacin more in the patients with severe AECB and in patients with more concomitant diseases, and so you can see that they used it more for the more ill patients," Kathrin Stauch commented.

Bayer HealthCare provided financial support for this study.


[Study title: Real-life Treatment of Acute Exacerbation of Chronic Bronchitis – Moxifloxacin Compared to Macrolides. Abstract P1055]

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