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Page: << Prev | 1 | 2 | 3 | 4 | Next >> 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.
So, why do the Stanford results differ from those of prior studies?
According to Witteles, the patients in his team's study more accurately reflect those seen by doctors generally -- older patients whose situation when they arrive at the hospital is not so dire that they need the highly concentrated shot of Natrecor used in earlier trials.
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"The lower dose [we used] is not associated with renal dysfunction the way that perhaps the higher dose is," Witteles reasoned. The lower dose is also the one approved for use by the FDA, he added.
Witteles also believes that Natrecor has both beneficial and detrimental effects on the kidneys. At the lower dose used in the study, "they simply cancelled each other out," he said, leading to a nil effect on kidney function.
The bottom line, according to Witteles: "I think [Natrecor] should be used in a particular context as well as in a particular fashion. I still believe that nesiritide is a very useful drug in the appropriate person."
That explanation doesn't satisfy Sackner-Bernstein, however, who called the new study "well-designed and well-executed" but also flawed.
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."
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