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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

ZURICH, Aug. 27 /PRNewswire/ -- Nycomed and Forest Laboratories today announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to severe COPD.

COPD is an under-diagnosed progressive lung disease that may lead to death. Worldwide, COPD kills four people every minute and the World Health Organization (WHO) predicts that it will be the third leading cause of death by 2030. WHO estimates that 80 million people have moderate to severe COPD.

Roflumilast, a once-a-day oral tablet, would be the first in an entirely new class of treatment for COPD if it receives regulatory approval from the authorities in Europe (EMEA) and the US (FDA). The phase III placebo-controlled trials of roflumilast evaluated the treatment in two 12-month (Lancet 2009; 374: 685-694) and two six-month studies (Lancet 2009; 374: 695-703), involving 4,500 patients in ten countries. Details of the results of the four studies will be published in The Lancet on August 29 (data and information under embargo until Friday, August 28 at 00:01am GMT).

The two 12-month studies published in The Lancet demonstrated that roflumilast produced a statistically significant and clinically relevant reduction in exacerbations (lung attacks that need treatment with systemic steroids or lead to hospitalisation), even for patients who were also taking long-acting bronchodilators. The studies showed a reduction in moderate to severe exacerbations by 17 percent per patient per year (rate of 1.14 events per year with roflumilast vs. 1.37 per year with placebo, p<0.001). The reduction in exacerbations was irrespective of concomitant treatment with long-acting
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