MONDAY, Oct. 23, 2006 (HealthDay News) -- A treatment involving two common medications is the first drug intervention to prolong life for patients with chronic obstructive pulmonary disorder (COPD), a major new trial confirms.
According to the American Lung Association, more than 122,000 Americans, most of them smokers or former smokers, die annually from this debilitating, progressive respiratory illness, which is the number four killer in the United States.
While some drugs can ease the symptoms of COPD, researchers say that only this drug combination -- an inhaled corticosteroid, fluticasone propionate (brand name Flovent/Flonase) plus a bronchodilator called salmeterol (Advair) -- has the power to push back underlying disease and improve patient survival.
"This is one of the most important trials that's ever been done in this field. The study clearly showed a benefit, and I think our practice will follow the information from this clinical trial," said one expert, Dr. Ron Grossman, professor of medicine at the University of Toronto. He was not involved in the study.
The results of the trial, the largest of its kind ever conducted with COPD patients, were to be announced Monday the American College of Chest Physicians annual meeting, in Salt Lake City.
The trial, called Toward a Revolution in COPD Health (TORCH), was a global effort involving researchers in Australia, Demark, Great Britain and the United States. It was led by Dr. Bartolome Celli of Caritas-St. Elizabeth's Medical Center in Boston.
The more than 6,100 patients with moderate-to-severe COPD enrolled in the trial were randomly assigned to one of four groups. One-quarter of the patients received the steroid fluticasone, another quarter got the bronchodilator salmeterol, a third group received both drugs in combination, and the fourth group received a placebo.
Over a period of three years, the group that received both medications experienced an 18 percent decline in deaths compared to the placebo patients. In contrast, death rates were similar to patients on a placebo for those groups taking just one of the drugs.
Patients on the two-drug therapy also had significantly fewer disease flare-ups, better lung function, and an improvement in their quality of life compared to the other participants.
For patients suffering from COPD, this may be the best news they've heard in years, experts say.
"It's true that, other than inhaling oxygen, this is the first study to show an intervention in COPD that has prolonged life," said Dr. Norman Edelman, chief medical officer at the American Lung Association.
COPD, which is largely brought on by years of smoking, is actually a combination of two diseases. On the one hand, patients suffer from chronic bronchitis -- a narrowing of the airways caused by inflammation. "We can treat the symptoms of bronchitis with anti-inflammatories -- Advair contains that kind of drug," Edelman said.
Much tougher to treat is COPD's deadlier second component, emphysema -- a gradual, irreversible destruction of lung tissue that's also strongly linked to smoking. "Unfortunately, we have not yet learned to regrow lung," Edelman said.
"Traditionally, what we have taught is that the only thing that alters the natural history of COPD is smoking cessation," Grossman added. Patients with severe COPD often experience dangerously low blood-oxygen levels, so many require oxygen therapy to survive.
So far, available drugs have had no impact in terms of extending survival, although they may help patients breathe easier. The new combination treatment appears to do more, however.
Still, questions remain. Salmeterol has had a checkered history as an asthma treatment, with studies suggesting a slight excess of sudden deaths of uncertain cause among users vs. nonusers. No such trend emerged in the TORCH trial, and Edelman said the problem "has only ever been shown when salmeterol is used alone. It's never been seen when it's used with an inhaled steroid [like fluticasone]."
Side effects in patients who used the two drugs together were minimal and easily managed, Grossman added. In fact, declines in bone density that have sometimes been linked to chronic steroid use weren't seen in the TORCH trial, he said.
Both drugs are relatively inexpensive. Grossman estimated per-patient treatment costs at under $2,000 a year.
It's unclear whether fluticasone/salmeterol will benefit patients with milder disease, since they weren't included in the study.
According to Grossman, patients with milder COPD may need to be steered toward a non-pharmacologic option that's long been proven to curb the illness.
"What we really need to do with mild cases is to be very vigorous in persuading people to stop smoking," he said. "That's probably a better solution in those cases than throwing drugs at them, which may tacitly tell them anyway that 'You can continue smoking.' "
More information
Find out more about COPD at the American Lung Association.
