Widely Used Medication Not Effective for Most Patients with Chronic Obstructive Pulmonary Disease (COPD)

Wednesday, December 27, 2000

ROCHESTER, MINN. — A recent study, conducted at Mayo Clinic and published in the December 28th edition of the New England Journal of Medicine, has found that patients who suffer from chronic obstructive pulmonary disease (COPD) receive very little long-term benefit from the use of inhaled corticosteroids. These widely prescribed medications do not inhibit the decline in lung function caused by the disease and offer only a slight reduction in specific flare-ups of the disease. Negative side effects from the medications also were observed.

"Inhaled corticosteroids are among the most commonly prescribed medications for the treatment of COPD," says Paul Scanlon, M.D., a Mayo Clinic pulmonary and critical care specialist and the study's principal investigator. "Based on our negative findings, I think we need to take a serious look at how and why we are prescribing these medications for patients with COPD."

Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. It is thought to be the result of airway inflammation from cigarette smoking, which leads to a progressive decline in lung function. Over 100,000 Americans die each year from COPD, making it the fourth leading cause of death in the United States. Prevalence of the disease is on the rise, particularly in American women, due to the proliferation of smoking, which is the primary cause of the disease.

Corticosteroids, such as triamcinolone, are inhaled, anti-inflammatory medications related to cortisone and prednisone. Although approved by the FDA for the treatment of asthma, they are also widely prescribed for the treatment of COPD. This is due in part to similarities between the two illnesses.

In cases of asthma, inhaled corticosteroids have been shown to alleviate airway inflammation, improve lung function and also to reduce airway reactivity. The rationale for use in COPD is that these medications would slow the rate of decline in pulmonary function in COPD patients also by reducing airway inflammation. Unfortunately, the type of inflammation is different and the treatment has proved to be less effective for patients with COPD.

The study enrolled 1,116 participants from the earlier Lung Health Study, all of whom were current smokers or recent quitters. They all had mild to moderate cases of COPD and were at increased risk for declining lung function.

"We conducted a randomized, placebo-controlled clinical trial which showed no difference in the rate of decline in lung function between those who used inhaled triamcinolone and those who used placebo," says Dr. Scanlon. "The active treatment group had slightly fewer flare-ups of COPD such as emergency room visits, hospitalization and symptoms but not enough to warrant the widespread use of the medication."

In addition to the results showing no significant long-term effects on the progression of COPD, there were also negative side effects related to the use of inhaled triamcinolone. Patients who used the medication for three years during the study showed a small loss in bone density. There were also more instances of skin bruising in the triamcinolone group, which may suggest capillary fragility.

"The findings raise questions about the appropriateness of the current frequent use of this medication for COPD," says Dr. Scanlon. "Although inhaled corticosteroids continue to give substantial benefits to asthma sufferers, the research suggests that for COPD we need to weigh any potential benefit against the long-term adverse effects on a case-by-case basis."

The study was funded by the National Heart, Lung, and Blood Institute and conducted in cooperation by 10 clinical centers in North America: University of Alabama – Birmingham, UCLA, Case Western Reserve University in Cleveland, Henry Ford Hospital in Detroit, Johns Hopkins Hospital, Mayo Clinic, Oregon Health Sciences University, University of Pittsburgh, University of Utah and University of Winnipeg. The University of Minnesota Department of Biostatistics was the data coordinating center.

Contacts: Lee Aase 507-266-5005 (days) 507-284-2511 (evenings) e-mail: newsbureau@mayo.edu

Chris Gade 507-284-5005 (days) 507-284-2511 (evenings) e-mail: newsbureau@mayo.edu

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