TORONTO -- May 26, 2008 -- Chronic intermittent pulsed therapy with moxifloxacin provided significant reductions in the frequency of exacerbations in chronic obstructive pulmonary disease (COPD), according to findings presented here at the 104th International Conference of the American Thoracic Society (ATS).
The results were presented here on May 18 by lead author Sanjay Sethi, MD; Attending Physician; Department of Pulmonary, Critical Care, and Sleep Services; Veterans Affairs Western New York Healthcare System in Buffalo, New York.
Frequent exacerbations of COPD increase both morbidity and mortality. They may result in a faster decline of lung function and may lead to a significant reduction in quality of life. Reducing both the frequency and severity of these exacerbations is one of the main goals of maintenance therapy.
Long-acting bronchodilators and inhaled corticosteroids are commonly used but have only moderate efficacy.
In a poster presentation, Dr. Sethi said that as many as 40% to 50% of COPD exacerbations may be related to bacterial infections. Bacterial strains that are new to patients are thought to be the main cause of acute exacerbations. Current therapeutic approaches focus on treating the exacerbations as they happen.
An effective suppressive regimen might involve disrupting the cycle of chronic bacterial colonisation and chronic inflammation, which might lead to fewer exacerbations.
That rationale led to this randomised, double-blind, parallel-group, multicentre trial conducted at 76 centres in 15 countries. Treatment was administered for 5 days every 8 weeks for a total of 6 courses. Patients were randomised to moxifloxacin 400 mg once daily or placebo once daily.
Patients were evaluated for exacerbations and adverse events for up to 24 weeks post-treatment.
The primary efficacy endpoint was frequency of exacerbations from randomisation to the end of treatment at 48 weeks in the per-protocol (PP) end-of-therapy (EOT) population.
A total of 1,404 patients were assessed for eligibility; 573 patients were randomised to receive moxifloxacin and 584 to placebo. Four patients in each group did not receive treatment, thus the intention-to-treat (ITT) arms had 569 and 580 patients, respectively. The PP EOT populations consisted of 351 patients in the moxifloxacin group and 387 in the placebo arm.
Approximately 31% of PP EOT patients in both arms were colonised by a respiratory pathogen at baseline. Approximately 10% of both groups were colonised by Haemophilus influenzae at baseline.
In both the ITT and the PP EOT groups, the significant variables influencing the number of exacerbations (P <= .05) were the severity of the underlying COPD as measured by the percent of predicted forced expiratory volume, treatment versus placebo, number of exacerbations in the previous year (<2>=2), and baseline colonisation with H influenzae (no baseline colonisation vs colonisation).
Geographic regions also demonstrated significant differences. Each region was compared with the mean value for all the other regions. In the ITT population, the use of systemic corticosteroids was an additional risk factor for exacerbations.
The study results also confirmed that antibiotics such as the fluoroquinolone moxifloxacin may provide benefits to maintenance therapy by preventing exacerbations and the subsequent inflammatory response, the researchers noted.
Original article located at www.docguide.com
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