Heart Failure Drug Found to Help Symptoms but Not Survival

Mar 27, 04:50 AM

Current Headlines: By Marilynn Marchione

NEW ORLEANS -- An experimental drug is the first to substantially and safely improve shortness of breath and other symptoms in people hospitalized with severe heart failure, an epidemic that is growing as baby boomers age, doctors reported Sunday.

However, many were disappointed that the drug also did not help people live longer or stay out of the hospital. "What we really need are therapies that are going to improve the outcome," said Dr. Gregg Fonarow, an American Heart Association spokesman from the University of California at Los Angeles. He had no role in the study.

Results of the study were published online by the Journal of the American Medical Association and will be in its March 28 issue.

Severely ill heart failure patients need to shed buckets of water, but current treatments either do not cause this fast enough or lead to kidney damage or loss of essential body salts called electrolytes. The new drug, tolvaptan, is a first-of-its-kind medication that blocks a hormone responsible for fluid retention. It was tested on 4,133 severely ill patients throughout North and South America and Europe. They were randomly assigned to receive either the new drug or fake medication in addition to other standard heart failure treatments like diuretics within 48 hours of hospitalization.

Ten months later, the drug made no difference in the rate of death or rehospitalization -- a big disappointment. It significantly improved breathing and reduced swelling and weight, however, because it promoted so much fluid loss.

"This is the first drug that's ever been documented to reduce symptoms and be safe," said Dr. Marvin Konstam of Tufts-New England Medical Center, who presented the study results Sunday. "There was an improvement in shortness of breath."

Tolvaptan's maker, Otsuka Pharmaceutical Co. of Japan, paid for the study. The company plans to ask the federal Food and Drug Administration to approve the drug sometime this year.

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A closer look

Heart failure occurs when the heart gradually weakens and can no longer pump blood effectively.

Fluid backs up into the lungs, and rhythm problems can lead to sudden death.

The condition afflicts about 5 million Americans, is the leading expense for Medicare and leads to more than 300,000 deaths a year.

Symptoms include shortness of breath or trouble breathing; swelling in the ankles, feet or legs; frequent fatigue; big or sudden weight gain; and coughing while lying down, especially at night.

Risk factors include smoking, being overweight, high-fat or high- cholesterol diets, and high blood pressure, heart disease or diabetes.

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