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Four Studies Published in The Lancet Show roflumilast (Daxas(R)), a New Oral Approach to COPD, Improves Lung Function and Reduces Exacerbations
Date:8/27/2009

s were over 40, and either former or current smokers with a smoking history of at least 20 pack-years. The patients had symptoms of chronic cough and sputum, their post-bronchodilator FEV(1) was less than or equal to 50percent of the predicted value and they had at least one documented moderate to severe exacerbation in the previous year. Approximately 50percent of the patients were concomitantly using long acting beta agonists.

Patients were permitted to use short-acting bronchodilators to relieve their symptoms as needed.

Compared with placebo, roflumilast significantly reduced the rate of exacerbations and improved lung function in treated patients. The rate of moderate to severe exacerbations in the study period (pooled data) was 1.14 per year in the patients treated with roflumilast compared with 1.37 per year, in the placebo group. This represents an improvement of 17 percent (RR 0.83; CI 0.75-0.92, p<0.001).

The pooled data for lung function using the pre-bronchodilator FEV(1) measurement (forced expiratory volume in one second) showed an average increase of 48mL (p<0.001) in roflumilast treated patients compared with the placebo group. The improvement in post-bronchodilator FEV(1) was 55mL (p<0.001) with roflumilast.

The differences found in exacerbation rates and lung function were similar irrespective of whether roflumilast was used with or without a long-acting beta-agonist.

Using another measurement, FVC (forced vital capacity, the lung capacity measured when the patient is exhaling for as hard and as long as possible) roflumilast patients also scored higher with an average increased FVC of 98 mL (p<0.001) compared with the placebo group. These patients had not used a bronchodilator prior to testing. The improvement in post-bronchodilator FVC was 101 mL (p<0.001).

Roflumilast was well tolerated by most patients. Slightly more
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SOURCE Nycomed
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