New hope for heart failure patients

Arthritis drug may slow disease progression

HOUSTON, Texas (CNN) -- A genetically engineered protein called Enbrel, approved last year for the treatment of rheumatoid arthritis, is continuing to show promise against another threat -- congestive heart failure.

The leading cause of hospitalizations for older Americans, congestive heart failure is a progressive weakening of the heart muscle that robs the organ of its ability to pump. It affects 4.5 million people in the United States and some 400,000 new cases are diagnosed each year.

The debilitating and deadly condition is often characterized by swelling of the ankles and legs and shortness of breath -- particularly when lying down. Half of those who have the disease will die within five years.

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"My heart was just gradually getting worse," said Gloria Audd, who had a heart attack at age 50 and has since had a bypass and two angioplasty procedures. "I was just getting to the point where I couldn't hardly move, and I couldn't go any place."

Audd had developed heart failure, and her weakened heart could not sustain much activity. Standard treatments were tried, but were not very effective, she said.

Doctors asked her to try Enbrel, the commercial name for the genetically engineered protein etanercept. Researchers are beginning to link heart disease to inflammation -- the same culprit that causes arthritis pain in joints.

"The concept with etanercept, or Enbrel, was that we're reducing inflammation within the myocardium, and hoping the myocardium will actually heal," said Dr. Douglas Mann of the Baylor College of Medicine. "We've been able to demonstrate that those patients actually had reversal in the size of their heart... as well as improvement in their overall functional capacity and... in quality of life."

Etanercept tackles a substance called tumor necrosis factor, explained Dr. Andrew Smith, medical director of the heart failure and transplant program at Emory University School of Medicine in Atlanta, Georgia. "The failing heart produces TNF, and it's thought that there is an association between muscle-wasting syndromes and the activation of this substance," Smith said.

Etanercept "is an interesting drug," the Emory assistant professor of cardiology continued. "This drug is a receptor to this substance (TNF) so it binds there and becomes inactive."

Mann, along with colleagues at the University of Pittsburgh Medical Center in Pennsylvania, reported on a Phase I trial with etanercept last year, saying the drug appeared to significantly improve quality of life for some patients.

Audd has been taking Enbrel almost two years now, and she is convinced it has benefits.

"I don't know what I'd have done without it," she said. "In my walking, there's no comparison. I used to have to stop every few feet, and I had angina. Now I can get pretty far, and sometimes I get a little out of breath."

Enbrel may slightly improve heart function, but is not a cure, Mann said. A study of 47 patients followed over three months found that 60 percent of those receiving high doses of etanercept improved, while half of those on lesser doses did.

Still, Enbrel has not become a standard of care of heart failure. A large, multi-center trial is now ongoing with nearly 1,000 patients enrolled, said Smith. "It will go on for several years," he added, saying the trial is to "look at whether giving this drug long-term is going to have benefit, improve survival, make people feel better and reduce hospitalization."

Smith said he is "cautiously optimistic" about the results so far, but "from a practical standpoint, the downside is it's very expensive."

Etanercept is administered by injection, similar to insulin, and costs an average of $1,500 a month, Smith said.

Still, it shows promise against several other conditions as well, including Crohn's disease, ulcerative colitis and psoriasis. "These are chronic inflammatory conditions," said the Emory cardiologist.

CNN Medical Correspondent Rhonda Rowland and CNN.com Health and Food Writer Michele Dula Baum contributed to this report.

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Congestive heart failure and high blood pressure linked
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American Heart Association: Congestive heart failure facts
Heart Information Network
Baylor College of Medicine
University of Pittsburgh Health System
Emory University

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