Study Supports Controversial Heart Failure Drug

The trial was too small to draw any firm conclusions, he said, and it also failed to address one important concern. The Stanford researchers "didn't look beyond hospitalization" when tracking the drug's effect on the kidneys, Sackner-Bernstein pointed out.

According to prior data, Natrecor-associated kidney problems only emerged in the weeks and months after a patient had been discharged from the hospital, Sackner-Bernstein said.

Witteles' team restricted their kidney tests to just the few days the ADHF patients were hospitalized. "Then they said, 'Look, there's no real risk,' " Sackner-Bernstein said. "Well, that's simply not the period of time in which the renal risk appears to exist. And, if you do not look for it, then, of course, you aren't going to find it."

Because of its small size and short follow-up, the Stanford study also failed to address the most important question of all: Does Natrecor increase patients' risk for death?

"Certainly this trial does not even attempt to answer mortality questions," Witteles agreed.

Those questions may only be answered by the large, prospective trial currently under development. "I think that that is the trial that will settle the matter," Sackner-Bernstein said. "That's the kind of trial I first asked for."

The results of that study will not arrive for at least four or five years, however. In the meantime, the debate over Natrecor continues.

More information

For more on heart failure, visit the American Heart Association.

SOURCES: Jonathan Sackner-Bernstein, M.D., associate chief of cardiology and director, Heart Failure Program, St. Luke's-Roosevelt Hospital Center, New York City; Ronald Witteles, M.D., instructor, cardiovascular medicine, Stanford University School of Medicine, Stanford, Calif; Oct. 30, 2007,Journal of the American College of Cardiology, online