Study Supports Controversial Heart Failure Drug

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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.

Critics quickly put the pressure on the drug's maker, Scios Inc., to initiate a large, prospective randomized controlled trial. Such a trial is already in the recruitment phase and organizers hope to gather 7,000 patients.

The Stanford study -- also funded by Scios -- was much smaller and was conceived before the controversy broke, Witteles said.

In the trial, 75 patients admitted to a hospital with ADHF received either Natrecor or a placebo within 12 hours of admission, for two days.

Since impaired kidney function was the main area of concern, the Stanford researchers used standard methods to assess each patient's kidney function during the first seven days of hospitalization. They also looked at rates of patient death or rehospitalization, or the need for dialysis or other care, over the following 30 days.

"The main findings were that nesiritide did not cause renal [kidney] dysfunction in high-risk patents who were hospitalized with heart failure," Witteles said. He stressed, however, that Natrecor also failed to prevent kidney trouble, so doctors should not use the drug in hopes of preserving kidney function.

Average length of hospital stay was similar for those on Natrecor or placebo -- four days. Four patients taking Natrecor died within 30 days compared to two on a placebo, but those numbers were far too small to represent any solid trend, Witteles said.