Curated by Luigi Ferritto (1), Walter Ferritto (2) |
Introduction
One death every 15 seconds in the world, with 2.6 million sick and 18 thousand deaths per year only in Italy.
These are the numbers of COPD (chronic obstructive pulmonary disease), a progressive lung disease for which there is often no possibility of treatment.
This condition affects the respiratory tract, causing difficulty in breathing primarily with cough and shortness of breath during efforts that require slight physical effort.
Roflumilast: Clinical Effectiveness
Daxas ® (roflumilast) is the first drug of this new class of medicines (phosphodiesterase 4 inhibitors), a pill that is taken once a day in order to fight the inflammation that is the basis of COPD.
For the first time, in fact, in addition to the classic bronchodilators, a drug to be taken by mouth reduces exacerbations and improves lung function.
Four Phase III studies have been published in The Lancet for Roflumilast, the new phosphodiesterase 4 inhibitor (PDE4) developed by Nycomed and Forest Laboratories. Studies have been conducted in patients with moderate to severe COPD, in whom roflumilast has been shown to improve lung function.
The Lancet studies are two phase III trials lasting 12 months (Lancet 2009; 374: 685-694) and two studies at 6 months (Lancet 2009; 374: 695-703), which together enrolled 4, 500 patients, in 10 countries including Italy.
The two studies at 12 months showed 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 was observed in the reduction of exacerbations.
Pulmonary function, measured by the evaluation of FEV (1), ie the volume of air exhaled in one second, was a primary co-end point of all 4 studies. FEV (1) improved on average by 48-80 mL (p <0.001).
The results, in addition to confirming 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 where it is very poor.
The Roflumilast molecule therefore presents a revolutionary mode of action and in the coming years it could become the only completely new alternative for the treatment of COPD.
For correspondence: Dott. Luigi Ferritto
Department of Internal Medicine Respiratory Physiopathology Unit "Athena" Villa dei Pini
Piedimonte Matese (CE)
