Press Release

VA Study Finds Steroid Therapy is Effective for a Common Form of Pulmonary Disease

Researchers from the Department of Veterans Affairs report in the June 24th issue of the New England Journal of Medicine that patients suffering from exacerbated chronic obstructive pulmonary disease (COPD)--a severe respiratory disorder--recovered more quickly when they received intravenous and oral corticosteroids.

Cigarette smoking causes 80 to 90 percent of all cases of chronic obstructive pulmonary disease, a combination of persistent bronchitis and emphysema that blocks the airways and traps air in the lungs. According to the American Lung Association, nearly 16 million Americans suffer from COPD, which is the fourth leading cause of death in the United States. Early symptoms range from shortness of breath when climbing a flight of stairs to a mild smoker's cough. As patients with COPD reach middle age and beyond they may suffer with respiratory impairments that are frequently severe and ultimately incapacitating. "The effects of cigarette smoking are cumulative. Significant symptoms of COPD typically begin beyond the age of 45 of 50," says Dennis E. Niewoehner, M.D., of the Minneapolis Veterans Affairs Medical Center who co-chaired the study with Marcia Erbland, M.D., of the Little Rock Veterans Affairs Medical Center. "Then it's a slow decline interspersed with periods when the disease becomes much worse."

Usually triggered by infections, these exacerbated episodes of COPD frequently require hospitalization for eight to 10 days, "a very expensive and morbid event for the patient."

Over the past 20 years systemic corticosteroids, cortisone-like drugs that mimic hormones produced by the adrenal cortex, have become a standard treatment for exacerbated COPD. However, the effectiveness of this treatment for COPD had never been proven, and corticosteroids are not benign. Adverse effects from short-term use include secondary infections, high blood sugar, and a range of mood and behavioral changes. Long-term therapy may cause osteoporosis, cataracts, hypertension, myopathy--a weakening of the muscle tissues--and adrenal insufficiency. "Given all we know about the side effects of steroids," Dr. Niewoehner explains, "it is important to understand their benefits."

The study, conducted at 25 VA medical centers, divided 271 heavy smokers, 50 years of age or older, into three treatment groups. Eighty patients received eight weeks of corticosteroid therapy, consisting of intravenous methylprednisolone for 72 hours followed by a tapered dose of once-daily oral prednisone over eight weeks; 80 were assigned to receive two weeks of corticosteroid therapy; and 111 patients were given a placebo. Comparisons were made at 30, 90, and 182 days after the start of treatment.

Researchers found that the rate of treatment failure at 30 days--defined as further deterioration of health, a need for intubation (mechanically-assisted breathing) or death--declined from 33 percent in the patients receiving placebo to only 23 percent in the patients receiving steroids. Also, initial hospital stays for patients in the combined corticosteroid groups were 1.2 days shorter than in the placebo group (8.5 versus 9.7 days). Finally, spirometric tests, in which patients inhale to capacity and exhale as hard as they can, showed that air-flow obstruction improved faster in patients who received systemic corticosteroids than those who were given the placebo.

In addition, the researchers found that eight weeks of steroids were no better than two weeks. "It has been common practice to give patients extended doses of steroids and then taper the dose. This study is important because we found that all of the benefits of the drugs were present with only two weeks of therapy," says Dr. Niewoehner. "Eight weeks of steroids were no more effective, and there may be an additional risk of infection.

"Hopefully, this will change the way physicians administer steroids. We want people to breathe easier sooner, but we don't wish to harm them with unnecessarily long courses of steroid therapy."

Other authors of the COPD study include Robert H. Deupree, Ph.D., Dorothea Collins, Sc.D., Nicholas J. Gross, M.D., Ph.D., Richard W. Light, M.D., Paula Anderson, M.D., and Nancy A. Morgan, R.PH., M.B.A. Their work was supported by the Department of Veterans Affairs Cooperative Studies Program.

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