- The Washington Times - Sunday, March 25, 2007

NEW ORLEANS (AP) — 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 yesterday.

However, many were disappointed that the drug 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, which was led by Dr. Marvin Konstam of Tufts-New England Medical Center and presented at an American College of Cardiology conference. Results also were published online by the Journal of the American Medical Association and will be in its March 28 issue.

Heart failure occurs when the heart muscle weakens over time and no longer can pump effectively. Fluid can back up into the lungs and leave people panicked and gasping for breath.

About 5 million Americans have the condition. It kills more than 300,000 and accounts for 1 million hospitalizations each year.

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.

A drug that does this better is drastically needed, said Dr. Mariell Jessup, head of the heart failure center at the University of Pennsylvania, who was not involved in the study.

“What we’re doing now is not working. These patients come back over and over,” she said.

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 the new drug or fake medication in addition to other standard heart failure treatments such as diuretics within 48 hours of hospitalization.

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

Side effects mostly involved nuisances such as dry mouth and thirst, and no extra risk of death or kidney problems was seen — the main things that worried doctors.

“This is the first drug that’s ever been documented to reduce symptoms and be safe,” Dr. Konstam said. “As early as one day, taking just one pill, there was an improvement in shortness of breath, which is the No. 1 symptom patients complain about that drives them to the hospital.”

Tolvaptan’s maker, Otsuka Pharmaceutical Co. of Japan, paid for the study and Dr. Konstam is one of its consultants. The company plans to ask the Food and Drug Administration to approve the drug sometime this year.

If it gets approved, “we will have another option for patients that will relieve the primary symptom bringing them to the hospital,” said Dr. Clyde Yancy of Baylor University Medical Center in Dallas.

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