Monday, March 21, 2005

Danger Appears Associated with Nesiritide

Today at 4pm, the results of an important study will be posted on the website of the medical journal Circulation, the official journal of the American Heart Association.

This study shows a troubling association between the use of nesiritide (NatrecorTM) and worsening kidney function. It is well recognized in the medical community that worsening kidney function typically means there is a higher risk of death subsequently. I can't prove that is the case for nesiritide, especially since the manufacturer of this medicine has refused to let me ask any questions based on their data. (I asked several tims in the past.) But they have known about this possibility since 1999, it seems to me, and certainly since 2001. In late 2003, they acknowledged it in a press release.

Perhaps the publication of this manuscript will provide some momentum to force the company to acknowleged that this risk is important to people getting the medicine and even fund an appropriate trial to prove its significance (or perhaps prove that the association we report is a statistical fluke). None of their on-going studies address this concern, though they assert they do.

By 4pm today, just follow this link to see the manuscript, and hopefully become part of the concern that forces the right thing to be done. Understand, I do not believe this drug should be pulled from the market. It can have potent effects when a person is critically ill with no other option. But it's safety is not equivalent to the old drugs, including nitroglycerin, milrinone or simply diuretics. Those should be used first.

Read the paper from Circulation, the official journal of the American Heart Association before using nesiritide for the treatment of acutely decompensated heart failure.