NEW YORK (Reuters Health) – Roflumilast is safe and reduces exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) who are also using a long-acting beta-2 agonist (LABA), according to a report in the European Respiratory Journal online July 4.

“These results support the recommendation that roflumilast be used concomitantly with long-acting bronchodilators in patients with severe-to-very-severe COPD and symptoms of chronic bronchitis,” the authors advise.

They explain that two prior 12-month trials showed that roflumilast improved lung function and rate of exacerbations in patients with severe-to-very-severe COPD, who were allowed to receive short-acting beta-2 agonists (SABAs) as needed and who continued treatment with either short-acting muscarinic antagonists (SAMAs) or LABAs.

For the current study, Dr. Eric D. Bateman, at the University of Cape Town Lung Institute, South Africa, and colleagues in Europe, combined data from those two trials to look at the influence of concomitant LABA use, and the benefit in patients at greatest risk of exacerbations — i.e., those with two or more flare-ups in the previous year.

At baseline, 47% of the participants reported concomitant LABA use. The researchers found that roflumilast compared with placebo reduced the rate of moderate or severe exacerbations in this subgroup of patients (rate ratio 0.79; p=0.001) as well as in those not using a LABA (RR 0.85; p=0.039).

Just over a quarter of the patients, 27%, had two or more exacerbations in the previous year. Among them, moderate or severe flare-ups were also reduced with roflumilast (RR 0.78; p=0.002), according to the report.

There were no differences in adverse events in any of the subgroups, Dr. Bateman and colleagues report. They saw no evidence that roflumilast increased LABA-related adverse events such as tachycardia or cardiovascular events, or that LABAs increased the risk of roflumilast-related adverse events.

They conclude, “Roflumilast may be used to reduce exacerbations, improving dyspnoea and lung function, without increasing adverse events in COPD patients receiving concomitant LABAs.”

Reference:
Roflumilast with long-acting ?2 agonists for COPD: influence of exacerbation history
Eur Respir J 2011.