The study appears in this month's issue of Archives of Internal Medicine and focuses on the incidence of pneumonia in patients with COPD who were exposed to inhaled corticosteroid drugs, either alone or in combination with other drugs.
COPD is a progressive disease that makes it hard to breathe. It can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness and other symptoms. Cigarette smoking is the leading cause of COPD, and most people who have COPD smoke or are former smokers. Long-term exposure to other lung irritants, such as air pollution, chemical fumes or dust, also may contribute to COPD.
COPD is currently the fourth-leading cause of death in the United States, accounting for more than 120,000 deaths annually and costing more than $30 billion each year, according to the National Lung Health Education Program. It is estimated that more than 16 million Americans have COPD; however, that number is rising rapidly and the disease often goes undiagnosed, so some estimates put the actual number of Americans afflicted with the disease as high as 24 million.
Inhaled corticosteroids, used alone or in combination with other drugs for the treatment of asthma, are not approved for use alone in patients with COPD, but rather in combination with beta-antagonists, which dilate the lungs. The available inhaled steroid combinations are fluticasone/salmeterol, marketed byGlaxoSmithKline as AdvairTM, and budesonide/formoterol, marketed by AstraZeneca as SymbicortTM.
The inhalers are effective in relieving many of the symptoms of COPD, but have been associated with an increased risk of pneumonia in recent studies.
For the current study, researchers reviewed 18 randomized clinical trials, several of which were unpublished, involving nearly 17,000 patients in total. They compared the incidence of pneumonia in patients who had taken inhaled corticosteroids for at least 24 weeks versus patients who had taken a placebo, or patients who had taken combination inhaled corticosteroids and long-acting beta-antagonists versus patients who took only the long-acting bronchodilator.
Analysis of the results showed that inhaled corticosteroid use, alone or in combination with bronchodilators, for at least 24 weeks was associated with a significantly increased risk of pneumonia and serious pneumonia (60 to 70 percent increase); however, it was not associated with an increased risk of death. In absolute terms, the study showed that nearly one in every 47 patients with COPD using a corticosteroid inhaler for one year is likely to develop pneumonia linked to use of the drug.
"Our robust meta-analysis … clarifies that the risk of pneumonia reported as a serious adverse event, can be specifically attributed to the long-term use of the inhaled steroid component," the researchers wrote in their report.
Researchers advised that these results pertain specifically to COPD patients rather than asthma patients, and recommend that "clinicians should remain vigilant for the development of pneumonia with inhaled corticosteroids, as the signs and symptoms of pneumonia may closely mimic that of COPD exacerbations."
"Given the substantial emerging risk of pneumonia and its associated morbidity and mortality in patients with chronic obstructive lung disease, and the uncertain benefit of adding an inhaled corticosteroid to a long-acting bronchodilator, clinicians should re-evaluate the benefit-harm profile of long-term inhaled corticosteroid use among patients with COPD," said Sonal Singh, M.D., M.P.H., an assistant professor of internal medicine and lead investigator for the study.
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