Benefits should be weighed against downside, experts say
MONDAY, Feb. 9 (HealthDay News) -- The use of inhalers containing corticosteroids to treat chronic obstructive pulmonary disease (COPD) might increase the risk of pneumonia by as much as 70 percent, researchers report.
Inhaled corticosteroids, used to treat asthma, are not approved for use in COPD patients. However, one product that is marketed by GlaxoSmithKline, Advair, combines steroids with a beta-antagonist and is approved to treat COPD. A similar product, Symbicort, marketed by AstraZeneca, is currently under consideration for use in COPD patients.
"It is not that we didn't know the potential for these risks, but these risks must be balanced against the uncertain benefits of the drugs providing some symptom relief in these patients," said lead researcher Dr. Sonal Singh, an assistant professor of internal medicine at Wake Forest University Baptist Medical Center.
No one should stop using their inhaler based on this study, Singh said. However, the inhalers are not effective for COPD, "and then you have these substantial risks," he said.
The report is published in the Feb. 9 issue of the Archives of Internal Medicine.
For the study, Singh's team reviewed the findings of 18 clinical trials that included a total of 16,996 people. The researchers looked for cases of pneumonia among people who were using inhaled corticosteroids for at least 24 weeks.
They compared them with people who had used a placebo, and they also compared those who had used a combination of inhaled corticosteroids and long-acting beta-antagonists with those who had used only the long-acting bronchodilator.
The researchers found that people taking corticosteroids alone or in combination with bronchodilators increased their risk of developing pneumonia by 60 to 70 percent. However, this increase in pneumonia was not associated with an increased risk of dying.
Singh noted that the finding means that about one in every 47 people with COPD who uses a corticosteroid inhaler for a year is likely to develop pneumonia linked to use of the drug.
People should discuss the risks and benefits of the drugs with their doctor, Singh said. "You have to balance the risks, and, unfortunately, there are few options for patients with COPD."
COPD is a progressive, destructive disease of the lungs, usually brought on by smoking. There is no known cure. Symptoms include restricted breathing, secretion of mucus, oxidative stress and airway inflammation.
COPD is the fourth-leading cause of death in the United States, accounting for more than 120,000 deaths each year, according to the National Lung Health Education Program. It is estimated that as many as 24 million Americans have COPD, and the number is rising rapidly.
Katie Neff, a spokeswoman for AstraZeneca, noted that Symbicort is not currently indicated for the treatment of COPD, although the company is looking for the U.S. Food and Drug Administration to approve its use for the condition. In addition, she said, results from trials of the product involving people with COPD found no increase in pneumonia.
"Data from SHINE and SUN [two studies that looked at the drug in COPD patients] demonstrated that Symbicort was well-tolerated for six and 12 months respectively," Neff said. "The incidence of pneumonia-related adverse events was no different for the Symbicort-treatment arms compared to placebo."
Patty Johnson, a spokeswoman for GlaxoSmithKline, disagreed with the contention that Advair does not benefit people with COPD.
"The benefits of Advair for treating patients with COPD have clearly been established," Johnson said. "Advair reduces exacerbations of COPD by 30 percent."
Johnson noted that the finding that Advair increases the risk of pneumonia has been known and is covered on the product's package label and patient information insert. "Physicians need to look at the total benefit/risk profile for the product for all their patients," she said.
Dr. Norman Edelman, chief medical officer of the American Lung Association, noted the benefit of using steroids to treat COPD is still not clear.
"The issue is of importance as combinations of inhaled steroids and long-acting beta agonists are being increasingly marketed and used for COPD," Edelman said. "Advair is the main one now, Symbicort is likely to be approved for COPD by the FDA soon, and I am told another is on the way."
The most reasonable conclusion is that inhaled steroids do indeed increase pneumonia in COPD without increasing death from pneumonia, Edelman said.
"On the other hand, the combinations have been shown to decrease exacerbations of COPD and improve function," he said. "In addition, some data actually suggest, but do not prove, that they prolong life."
This study suggests that the beneficial effects of the combinations are due to the long-acting beta agonists -- bronchodilators -- and not the steroids and implies that the way to treat COPD is with these agents alone, Edelman said. "I am sure that we will see more analyses to this point," he added.
COPD is a major health problem worldwide, but researchers have yet to make the kind of progress made in other major causes of death, Edelman said.
"This may be because some have considered it to be a self-inflicted disease -- via cigarette smoking -- and not worthy of study, but that's unfair," he said. "Almost all smokers have been addicted as teenagers by a wealthy and voracious tobacco industry. Thus, more research focused on early detection and reversal of the lung destruction is needed."
The National Heart, Lung and Blood Institute has more on COPD.
SOURCES: Sonal Singh, M.D., M.P.H., assistant professor, internal medicine, Wake Forest University Baptist Medical Center, Winston-Salem, N.C.; Norman Edelman, M.D., chief medical officer, American Lung Association, New York City; Katie Neff, spokeswoman, AstraZeneca, Wilmington, Del.; Patty Johnson, spokeswoman, GlaxoSmithKline, Philadelphia; Feb. 9, 2009, Archives of Internal Medicine
All rights reserved