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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

he results of these studies, published in The Lancet, confirm that roflumilast is beneficial. It reduced exacerbations, or lung attacks, and significantly improved lung function, in a patient population whose lung function is very poor."

Professor Leonardo Fabbri, Professor of Respiratory Medicine, University of Modena and Reggio Emilia, Italy, and lead author of the six-month studies, said: "Roflumilast has a novel mode of action and has the potential to become the first of a new class of drugs and potentially the only completely new treatment option for COPD in the next several years. These eagerly awaited results, published this week in The Lancet, show that in addition to confirming the sustained statistically significant improvements in lung function, roflumilast also showed a trend to reducing exacerbations when given in addition to long acting inhaled bronchodilators. The results of the two six-month trials examining the additive effect of roflumilast on top of salmeterol or tiotropium support and extend the findings of the 12-month trials, by showing a clinically relevant lung function improvement in patients with impaired lung function on top of maximum bronchodilation."

"The lung function improvements on top of current bronchodilation clearly indicates that roflumilast improves lung function over and above what can be achieved with other COPD treatments alone. It also demonstrates that roflumilast works in a different way to current treatments and supports roflumilast's potential to change how COPD is managed," added Professor Klaus Rabe, Professor of Medicine at Leiden University Medical Center, also a lead author of the six-month studies.

Nycomed's Executive Vice President R&D, Anders Ullman, said: "We are very pleased with the results published in The Lancet this week. In four studies, two 12-month studies and two six-month studies, roflumilast showed clear therapeutic
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