Nycomed Recently Announced That Roflumilast, Improved Lung Function And Reduced Exacerbations In Patients With Moderate To Severe COPD

Main Category: COPD
Also Included In: Respiratory / Asthma
Article Date: 06 Sep 2009 - 0:00 PDT

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COPD is an under-diagnosed progressive lung disease that may lead to death. In Canada, approximately 500,000 people over the age of 35 have been diagnosed with COPD, and it is estimated that an almost equal number of middle-aged Canadians may also have COPD, but are not aware of it.i In fact, by 2020, it is estimated that COPD will be the third leading cause of death worldwide.ii Roflumilast, a once-a-day oral tablet, would be the first in a new class of treatment for COPD. The safety and efficacy are still under investigation and market authorization has not yet been obtained from Health Canada. The phase III placebo-controlled trials of roflumilast evaluated the treatment in two 12-month and two six-month studies, involving 4,500 patients in ten countries, including 367 patients in Canada. Details of the results of the four studies were just published in The Lancet this week.

"Roflumilast improves lung function on top of bronchodilation and over and above concurrent COPD treatments by acting on the underlying inflammation," says Dr. Andrew McIvor, Professor of Medicine, McMaster University, Firestone Institute for Respiratory Health, St. Joseph's Healthcare. "Considering, the nature of the disease and its affect on people's lives, this presents a very exciting new option for those of us treating patients."

About the studies

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 hospitalization), 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 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.

Source
Nycomed