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Scientists Issue Warning On Heart-Failure Drug

Study suggests that use of nesiritide may increase risk of death; critics call on FDA to reassess medication

Apr 20, 2005 | Newsday

A drug designed to rescue heart-failure patients from crisis may instead dramatically increase their risk of dying within 30 days of leaving the hospital, medical experts said yesterday.

In an analysis of documents from the Food and Drug Administration as well as the pooled results of three studies, researchers found that nesiritide, an intravenous medication approved amid fanfare in 2001, does little to help patients and may even make them worse, researchers say.

The medication, produced by Scios Inc., a Johnson & Johnson subsidiary, and sold under the brand name Natrecor, is not cheap. The drug costs about $500 per infusion and patients are usually hospitalized. However, doctors have begun a new, off-label use of the drug in which patients are treated on an outpatient basis, a practice critics say may also increase the danger. An estimated 600,000 people have been treated with the drug since approval.

Led by Dr. Jonathan Sackner-Bernstein, director of clinical research at North Shore University Hospital's heart failure center in Manhasset, researchers found that patients on the drug were more likely to die after release from the hospital than those prescribed standard therapy or placebos.

For decades diuretics and nitroglycerin have been the medications of choice for severe heart failure, a condition in which the organ has lost the capacity to pump enough blood. The disorder's symptoms are shortness of breath, extreme fatigue and fluid build-up.

The drug is a genetically engineered version of a hormone that eases breathing. Doctors do not know how the drug may contribute to death.

"Nesiritide is a drug used during the period of time when symptoms are out of control," Sackner-Bernstein said, "and it can be used for several hours or several days.

"We estimated the risk of dying within 30 days of being treated with nesiritide is 80 percent higher," Sackner- Bernstein said, than for patients on standard therapy or dummy pills. He added that further study is needed.

Johnson & Johnson spokesman Mark Wolfe said the study, in today's Journal of the American Medical Association, is inaccurate. "Natrecor is highly effective for patients with acutely decompensated heart failure, a life-threatening condition for which there are limited treatment options."Wolfe said an extensive review of the drug soon will get under way.

But with the threat of death so apparent in previous work on the drug, Sackner-Bernstein said, patients should be administered the medication only as second- or third-line therapy. The current study is the second in a month to warn about the drug. The first, reported in the journal Circulation, showed that nesiritide also substantially increased the risk of kidney problems.

Dr. Steven Nissen, vice chairman of cardiology at the Cleveland Clinic, the lone dissenting member on the FDA panel that approved the drug in 2001, said it's time to reassess nesiritide. "I was very concerned about this drug from the very beginning and I made very strong statements about it," Nissen said yesterday. "I was opposed to its approval because of the safety issues."

In the studies reviewed by Sackner-Bernstein and his colleagues, 35 of 485 patients on nesiritide died within 30 days of treatment while only 15 of 377 patients on other treatments died.

Nissen hailed the study, saying Sackner-Bernstein "did the classic analysis."

QUOTES:

'I was very concerned about this drug from the very beginning and I made very strong statements about it. I was oppposed to its approval because of the safety issues.'

Dr. Steven Nissen, the lone dissenting member on the FDA panel that approved the drug in 2001


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