New drug might slow the destructive lung condition, studies show
THURSDAY, Aug. 27 (HealthDay News) -- Although there is no cure for chronic obstructive pulmonary disease (COPD), starting treatment early may slow progression of the illness and add years to the lives of sufferers, new research finds.
COPD is a progressive, destructive disease of the lungs that is usually brought on by years of smoking. Symptoms include restricted breathing, secretion of mucus, oxidative stress and airway inflammation. It is estimated that as many as 24 million Americans have COPD, and the number is rising.
Three reports published in the Aug. 29 issue of The Lancet, a special issue devoted to COPD, offer new insight into treatments, including a new anti-inflammatory drug that shows promise.
In the first report, patients who began treatment early with the inhaled drug tiotropium (Spiriva) had better outcomes compared with untreated patients.
"If you treat moderate disease with these anticholinergic drugs, you get clear improvements in lung function, health-related quality of life, exacerbations and even, maybe, in mortality, but that was not statistically significant, but there was a trend," said lead researcher Dr. Marc Decramer, a professor in the department of pathophysiology at University Hospital of the University of Leuven in Belgium.
In addition, "you seem to reduce the rate at which the disease progresses," he noted.
For the study, Decramer's group followed 2,376 patients with early COPD who took part in a study for four years. These patients were randomly assigned to receive Spiriva or a placebo.
The researchers found that the rate of decline in lung function was 12 percent lower among patients receiving Spiriva than for patients receiving the placebo.
In addition, patients taking Spiriva were healthier. Flare-ups of the disease were cut 18 percent, and hospitalizations resulting from flare-ups were reduced 26 percent, compared with patients taking the placebo, the researchers found.
For the best outcomes, Decramer said, COPD needs to be diagnosed in its early stages, and aggressive therapy should begin as soon as possible.
"We need to treat these patients earlier than we presently do," Decramer said.
Dr. Norman Edelman, chief medical officer of the American Lung Association, agreed that the findings highlight the need to start COPD treatment when the illness is still mild.
"The major new finding is the efficacy of an anticholinergic in patients with relatively mild COPD in improving lung function and quality of life," Edelman said. "The effects were small but seem real. This is of significance because it points out the usefulness of case finding and treatment of relatively early COPD cases, a somewhat neglected area in clinical practice."
Two other reports in the same edition of the journal show the benefit of the new drug roflumilast (Daxas) in treating COPD.
Daxas, an anti-inflammatory, is still going through the drug approval process in the United States and elsewhere.
In one study, Dr. Leonardo Fabbri from the University of Modena in Italy and colleagues randomly assigned 3,091 patients with severe COPD to Daxas or a placebo. Over a year, patients taking Daxas experienced improved lung function and had 17 percent fewer flare-ups than patients taking a placebo.
"These results suggest that different subsets of patients exist within the broad range of COPD, and that targeted specific therapies could improve disease management," the researchers concluded.
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
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