1) Department of Internal Medicine, Athena Villa dei Pini Clinic, Piedimonte Matese (CE);
2) Division of Internal Medicine, A.G.P. Piedimonte Matese (CE);
Introduction
One death every 15 seconds in the world, with 2.6 million patients and 18,000 deaths a year in Italy alone.
These are the numbers of COPD (chronic obstructive pulmonary disease), a progressive lung disease for which there is often no possibility of a cure.
This condition affects the respiratory tract, primarily causing difficulty in breathing with coughing and shortness of breath during efforts that require a slight physical effort.
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Roflumilast: Clinical Efficacy
Daxas ® (roflumilast) is the first drug in this new class of medicines (phosphodiesterase 4 inhibitors), a pill that is taken once a day to fight the inflammation underlying COPD.
In fact, for the first time, in addition to the classic bronchodilators, a drug to be taken by mouth reduces exacerbations and improves lung function.
Four phase III studies of Roflumilast, the new phosphodiesterase 4 (PDE4) inhibitor developed by Nycomed and Forest Laboratories, have been published in The Lancet. The studies were conducted in patients with moderate to severe COPD in whom roflumilast has been shown to improve lung function.
The Lancet studies are two 12-month phase III trials (Lancet 2009; 374: 685-694) and two 6-month studies (Lancet 2009; 374: 695-703), which in total enrolled 4,500 patients, in 10 countries including Italy.
The two 12-month studies demonstrated that roflumilast produces a significant reduction in exacerbations even in patients already on long-acting beta 2 agonist therapy. This reduction was 17% per patient per year: 1.14 events with roflumilast and 1.37 with placebo (p <0.001).
In the other two studies, when the drug was added to standard bronchodilator therapy, a clear trend in reduction of exacerbations was observed.
Pulmonary function, as measured by FEV, i.e. the volume of air exhaled in one second, was a primary co-end point of all 4 studies. FEV improved on average by 48-80 mL (p <0.001).
The results, in addition to confirming the important, prolonged and statistically significant improvements in lung function, show that roflumilast also revealed a tendency to reduce complications when administered in addition to long-acting inhaled bronchodilators. Roflumilast could therefore represent an important new treatment for COPD, reducing exacerbations and improving lung function even in patients in whom it is very poor.
The Roflumilast molecule therefore presents a revolutionary mode of action and in the next few years it could become the only completely new alternative for the treatment of COPD.
By Correspondence: Dr. Luigi Ferritto
Department of Internal Medicine Clinical Respiratory Physiopathology Unit "Athena" Villa dei Pini
Piedimonte Matese (CE)
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