In a second report, a research team led by Dr. Klaus F. Rabe, of Leiden University Medical Center in the Netherlands, tested the benefit of Daxas when added to standard COPD treatment with long-acting bronchodilators or anticholinergics.
In this trial, 1,677 patients with moderate-to-severe COPD were randomly assigned to Daxas or a placebo for 24 weeks. Patients were also receiving the bronchodilator salmeterol (Serevent) or the anticholinergic Spiriva.
The researchers found that adding Daxas to treatment with Serevent or Spiriva improved lung function over either drug alone. In addition, Daxas improved respiratory symptoms.
In both studies, Daxas was associated with more adverse side effects, including nausea, diarrhea and weight loss, researchers note.
"Roflumilast improves lung function in patients with moderate-to-severe COPD who are already being treated with long-acting bronchodilators [beta-2 agonists or anticholinergic drugs], although with expected class-specific adverse events. Roflumilast could become an important, concomitant treatment for these patients," Rabe's team wrote.
"These effects are clinically important, but not terribly striking," said Dr. Paul O'Byrne, a professor of medicine at McMaster University Medical Center in Ontario, Canada, and author of an accompanying journal editorial.
For now, there is still no definitive treatment for COPD or treatment that stops the progression in the decrease in lung function.
One problem with these studies is that they don't compare Daxas with inhaled corticosteroids, which are also anti-inflammatories, OByrne said. "We don't know what advantage roflumilast has in patients already taking inhaled corticosteroids," he said.
Dr. Neil Schachter, a professor of pulmonary medicine at Mount Sinai Medical Center in New York City, noted that with only three types of drugs available to treat COPD, something new would be beneficial.
"It's good to have new compounds introduced for the treatment of COPD ... because some patients won't respond to the three [types of] drugs now available," Schachter said.
For more information on COPD, visit the U.S. National Heart, Lung and Blood Institute.
SOURCES: Marc Decramer, M.D., Ph.D., professor, department of pathophysiology, University Hospital, University of Leuven, Belgium; Paul O'Byrne, M.B., professor, medicine, McMaster University Medical Center, Ontario, Canada; Neil Schachter, M.D., professor, pulmonary medicine, Mount Sinai Medical Center, New York City; Norman Edelman, M.D., chief medical officer, American Lung Association; Aug. 29, 2009, The Lancet