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| |  Roflumilast Combined With Salmeterol or Tiotropium Is Safe and Effective in COPD: Presented at ERS By Evelyn Harvey VIENNA, Austria -- September 16, 2009 -- The phosphodiesterase-4 inhibitor roflumilast in combination with bronchodilators salmeterol or tiotropium shows significant benefit in COPD patients, according to study research reported at the 19th Annual Congress of the European Respiratory Society (ERS). Synergistic adverse events were not observed, allaying concerns over the use of combined therapies incorporating roflumilast. The M-127 and M-128 studies were presented here at ERS on September 13 and 14 by José Luis Izquierdo, MD, Hospital Universitario de Guadalajara, Spain, and Klaus Rabe, MD, Leiden University Medical Centre, Leiden, the Netherlands. Previous studies have shown roflumilast to be safe and effective in COPD patients with moderate to severe disease, but there was a need to investigate the effects of roflumilast in combination with long-acting bronchodilators (long-acting beta2 agonists or LABA), which constitute a major therapeutic option in COPD. To be eligible for the trials, all subjects had to have clinically diagnosed COPD with postbronchodilator forced expiratory volume in 1 second (FEV1) of 70% or less of the predicted value. All subjects were aged 40 or over, and were current or former smokers. Patients on tiotropium in the M-128 study, however, were more symptomatic than subjects in the M-127 study, with chronic cough and more frequent use of LABA relievers (at least 28 puffs per week). Patients were stratified according to baseline characteristics, which were distributed similarly between groups. In M-127, subjects were assigned to treatment with daily oral roflumilast 500 mcg (n = 466) or to placebo (n = 467), with both groups receiving concomitant salmeterol 50 mcg twice daily. The structure of M-128 was similar, with 371 subjects assigned to daily oral roflumilast 500 mcg and 372 given placebo, plus a background of tiotropium 18 mcg once daily in both groups. The treatment period was 24 weeks, with a 4-week placebo run-in. Concomitant ICS treatment was not permitted. In subjects given roflumilast concomitantly with salmeterol, mean prebronchodilator FEV1 improved by 49 mL compared with salmeterol plus placebo (P < .0001) and mean postbronchodilator FEV1 by 60 mL (P < .0001). The mean annual rate of moderate or severe exacerbations was reduced by 36.8% (P = .0315) in the roflumilast group in a post hoc analysis. The median time exacerbation was also reduced (P = .0067), but this was not one of the original study endpoints. Similarly, significant improvements in lung function were seen in the roflumilast plus tiotropium patients when compared with those treated with tiotropium alone, with mean postbronchodilator FEV1 increased by 81 mL (P < .0001). The risk of exacerbation was also reduced, with a hazard ratio of 0.7 (P = .0264) favouring concomitant roflumilast treatment. As in previous studies, gastrointestinal adverse events and weight loss (mean 2.1 kg) were associated with roflumilast treatment. COPD exacerbations occurred more frequently in placebo groups. There was no difference in rates of cardiovascular, central nervous system or infection-related adverse events, which were low (<2%) across all groups. “Roflumilast could become important as a concomitant treatment for COPD, as it shows additive effects with long-acting beta2 agonists,” concluded Dr. Izquierdo. Funding for these studies was provided by Nycomed. [Presentation titles: Roflumilast Treatment Over One Year and as an Add On Therapy in COPD. Abstract 4793. and The PDE4 Inhibitor Roflumilast Provides Additional Clinical Benefit in COPD Patients Receiving Salmeterol. Abstract 1627. and Roflumilast, a PDE4 Inhibitor, Improves Lung Function in Patients With COPD Treated With Tiotropium. Abstract 1628]
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