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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

beta-2 agonists, a standard bronchodilator therapy.

When added to standard bronchodilator therapies in the two six-month studies, a clear trend for the reduction of exacerbations was observed with roflumilast, over and above what was achieved with these therapies alone. There was also a statistically significant difference with roflumilast in other prespecified endpoints, including median time to first exacerbation (moderate to severe in the salmeterol study, and mild, moderate and severe in the tiotropium study) and in the proportion of patients in both studies experiencing a mild, moderate, or severe exacerbation.

Lung function, as measured by FEV(1) (how much volume can be exhaled in one second), was the primary or co-primary endpoint in all four studies. Across the studies, roflumilast demonstrated a statistically significant improvement in pre-bronchodilator FEV(1), in the range of 48 to 80 mL (p<0.001).

Nausea, diarrhoea and weight loss were the most common adverse events recorded in patients in the four trials, but they were generally mild to moderate in intensity and generally occurred in the first weeks of treatment.

Professor Peter Calverley, Professor of Respiratory Medicine, University of Liverpool, UK, and the lead author of the 12-month studies, said: "COPD can devastate people's lives and exacerbations can be extremely frightening, so a novel tablet like roflumilast is really exciting for those of us treating patients. Roflumilast acts differently to bronchodilators as it acts on the underlying condition, not primarily impacting on everyday symptoms. It acts slowly and the effects, as we saw in our studies, are gradual and sustained."

"Roflumilast could be an important new treatment for COPD," added Professor Fernando Martinez, University of Michigan, also a lead author of the 12-month studies. "We clearly need new options for patients with COPD and t
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