NHLBI study shows inhaled corticosteroids do not slow progression of COPD

December 26, 2000

Ending a long controversy about the effects of inhaled corticosteroids in the treatment of people with chronic obstructive pulmonary disease (COPD), researchers supported by the National Heart, Lung, and Blood Institute (NHLBI) today reported that inhaled corticosteroids do not slow the progression of the disease, as many had hoped, but they do reduce respiratory symptoms in some of these patients.

The Lung Health Study (LHS) II, which appears in the December 28, 2000 New England Journal of Medicine, showed that patients treated with inhaled corticosteroids experienced no significant slowing of the decline in lung function that makes COPD ultimately deadly but did have fewer symptoms, lower health care utilization, and some improvement in the sensitivity of the lungs to external stimuli. However, they also had a small amount of bone loss and an increase in skin bruises compared to the placebo group.

Said NHLBI Director Dr. Claude Lenfant, "Inhaled corticosteroids are commonly prescribed for patients with COPD, although their effectiveness has not been consistently shown. These findings from LHS II provide us with the full picture of their benefits and risks.

"Smoking cessation is the only thing shown to slow the progression of COPD, but since this is often difficult to achieve, we are investigating other ways to prevent its progression," he added.

COPD is a term used for two closely related diseases of the respiratory system: chronic obstructive bronchitis and emphysema. It currently affects approximately 16 million Americans and is the fourth leading cause of death in the U.S. Research has shown that cigarette smoking is associated with 80-90 percent of COPD cases.

Chronic airway inflammation, induced by smoking, is thought to contribute to the development of COPD. Since inhaled corticosteroids have been shown to reduce airway inflammation in asthma, scientists had thought they might slow disease progression in patients with COPD. LHS II shows that this is not the case.

LHS II involved 1,116 participants, ages 40 to 69, with mild to moderate COPD who were either current smokers or smokers who had quit within the past two years. Participants were randomly assigned to receive either an inhaled corticosteroid or placebo. Lung function was evaluated every six months using spirometry.

The study showed that lung function decline in the patients treated with the inhaled corticosteroid was statistically no different from that in the placebo group. Corticosteroid use did, however, result in 25 percent fewer respiratory symptoms and nearly 50 percent fewer outpatient visits for respiratory problems. However, after three years, bone density in the hip and back was lower in the corticosteroid group.

Said Dr. Robert Wise, Professor of Medicine at Johns Hopkins University and an LHS II principal investigator, "The bone loss was not clinically important. However, we don't know whether it would progress with prolonged use of the drug. Physicians treating patients with COPD should weigh the benefits of inhaled corticosteroids against the potential risks."
-end-
Participating LHS clinical centers are: Case Western Reserve University, Cleveland, OH; Henry Ford Hospital, Detroit, MI; Johns Hopkins University, Baltimore, MD; Mayo Foundation, Rochester, MN; Oregon Health Sciences University, Portland; University of Alabama, Birmingham; University of California, Los Angeles; University of Minnesota, Minneapolis; University of Pittsburgh, Pittsburgh, PA; University of Utah, Salt Lake City; and the University of Manitoba, Winnipeg, Canada. The Data and Coordinating Center is located in the Division of Biostatistics, School of Public Health, University of Minnesota.

The drug used in LHS II was donated by Aventis, Inc., headquartered in Parsippany, NJ. The NHLBI is part of the National Institutes of Health, located in Bethesda, MD. For more information, contact the NHLBI Communications Office at (301) 496-4236.

NHLBI press releases, scientific resources, and other materials are online at http://www.nhlbi.nih.gov.

NIH/National Heart, Lung and Blood Institute

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