Study Supports Controversial Heart Failure Drug

MONDAY, Oct. 29 (HealthDay News) -- A new study supporting the safety of Natrecor, a widely used heart failure medication, is another volley in the ongoing battle over the drug.

Critics have charged that Natrecor, which costs about $500 a dose, adds little to patient outcomes and, in fact, may raise their risk of kidney failure and death.

However, the new study of 75 patients -- the first prospective trial of its kind -- showed no such trend during the week after the drug was given to patients hospitalized with heart failure. The study found Natrecor to be safe when given to those patients it was developed for: people with acute decompensated heart failure (ADHF).

"ADHF is really a broad definition," explained the study's lead author, Dr. Ronald Witteles, an instructor in cardiovascular medicine at Stanford University School of Medicine. "It encompasses anytime that patients with heart failure are hospitalized. They could be hospitalized for too much fluid and the so-called 'congestive' symptoms of heart failure. It could also be because their heart simply cannot pump enough blood to their organs."

The new finding, published in the Oct. 30 online edition of theJournal of the American College of Cardiology, isn't appeasing the drug's detractors, however.

"It's not enough to say, 'I have done a small study of 75 people, and [Natrecor] isn't heinous enough to see that it's bad, so how bad could it really be?' You actually have to show that it is safe," said Dr. Jonathan Sackner-Bernstein, associate chief of cardiology and director of the Heart Failure Program at St. Luke's-Roosevelt Hospital Center, in New York City.

He co-authored a 2005 retrospective analysis of data from three trials. It found that hospitalized heart failure patients who got Natrecor (nesiritide) faced an 81 percent higher risk of dying within 30 days, compared to patients who got a placebo.

More than 500,000 new cases of heart failure are diagnosed among Americans each year, but breakthroughs in treatment have remained elusive.

The usual first-line therapy is diuretics, drugs that flush water from the body, with nitroglycerine used as an alternative. Natrecor, approved by the U.S. Food and Drug Administration in 2001, is used to strengthen heart function.

The drug "was the first new treatment for decompensated heart failure in over a decade, and there is yet to be another one," Witteles noted.

Heart specialists welcomed any new weapon against ADHF, so Natrecor's annual sales soon soared into the hundreds of millions of dollars. But then reports like Sackner-Bernstein's began to surface, taking away some of the drug's luster.

Debate over Natrecor's safety and efficacy "became, certainly in the last five years, the biggest controversy I can think of in heart failure," Witteles said.