March 25 (Bloomberg) -- Johnson & Johnson's Natrecor, a drug linked to reports of kidney damage and deaths in 2005, was safe in a study of patients with severe, chronic heart failure. It didn't prolong their lives.

Natrecor, which helps the heart pump better, was approved by U.S. regulators in 2001 to relieve symptoms such as difficulty breathing in patients hospitalized with worsening heart failure. Some doctors also gave it to patients with chronic disease to slow its progression.

A study published in March 2005 suggesting Natrecor worsened kidney function was followed a month later by research that found the drug might increase death rates. The latest report, presented today at the American College of Cardiology meeting in New Orleans, contained a mixed message.

``It's very clear that the outpatient administration of nesiritide,'' as the drug is known chemically, ``did not result in any clinical benefit,'' said Clyde W. Yancy, director of Baylor University Medical Center's Heart and Vascular Institute in Dallas. ``We can finally begin to exhale a little bit regarding the previously expressed concerns about safety.''

About one million people are hospitalized each year with heart failure, a weakening and enlargement of the organ so that it can no longer efficiently pump oxygen-rich blood to the rest of the body. It causes fluid to build up in the lungs, legs and feet, restricting patient breathing and mobility.

Sickest Patients

The new work included 920 of the sickest patients, those who had been previously hospitalized and were at high-risk for future complications. Patients were given Natrecor once or twice weekly for 12 weeks, then followed for several months. The intensive treatment in such a sick group of patients likely would have magnified any risks from the drug, Yancy said.

Patients also were given optimal drug treatment, including diuretics and a host of medications to lower blood pressure. The intensive therapy paid off, though that level of care makes it difficult for any one new drug to show a benefit, he said in an interview yesterday.

Among the sickest of the sick, 70 percent of patients used to die or be hospitalized within three months, he said. Now, that's down to 40 percent when such intensive care is used.

Johnson & Johnson, based in New Brunswick, New Jersey, is starting a $100 million trial of the drug that will involve 7,000 patients in Europe, Canada and the U.S., looking at its safety and effectiveness.

Prescriptions Plunged

Prescriptions of Natrecor plunged even among patients approved for the drug after the negative studies were published in 2005. Just 5.6 percent of patients hospitalized with severe and worsening heart failure got the drug in December 2005, down from 16.6 percent nine months earlier in March, a study in the Journal of the American Medical Association last year found.

Natrecor generated $63.8 million from January through July of 2006, a 72 percent drop from the same period in 2005, according to data compiled by IMS Health Inc., a Fairfield, Connecticut-based company that tracks prescription trends. J&J doesn't break out revenue from products that generate less than $500 million annually.

Earlier this month, Johnson & Johnson said it received subpoenas from U.S. attorneys in Boston, Philadelphia and San Francisco over allegations it marketed Natrecor and two other drugs for unapproved uses. A year ago, Medicare, the U.S. insurance program for the elderly and disabled, announced it wouldn't pay for Natrecor, which can cost $500 a day, for chronic heart failure patients

Shares of J&J fell 35 cents to $61.51 March 23 in New York Stock Exchange composite trading.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

Last Updated: March 25, 2007 13:57 EDT