John Henry
New member
Found this Article dated 08-30-09... Sounds promising.
Four Studies Published In The Lancet Show Roflumilast (Daxas(R)), A New Oral Approach To COPD, Improves Lung Function And Reduces Exacerbations
Main Category: COPD
Also Included In: Clinical Trials / Drug Trials; Respiratory / Asthma
Article Date: 30 Aug 2009 - 0:00 PDT
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer and Nycomed, a privately owned pharmaceutical company, 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.
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 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 FEV1 (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 FEV1, in the range of 48 to 80 mL (p<0.001)
Four Studies Published In The Lancet Show Roflumilast (Daxas(R)), A New Oral Approach To COPD, Improves Lung Function And Reduces Exacerbations
Main Category: COPD
Also Included In: Clinical Trials / Drug Trials; Respiratory / Asthma
Article Date: 30 Aug 2009 - 0:00 PDT
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer and Nycomed, a privately owned pharmaceutical company, 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.
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 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 FEV1 (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 FEV1, in the range of 48 to 80 mL (p<0.001)