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Nesiritide May Inhibit Furosemide-Associated Aldosterone Spikes: Presented at HFSA

By Bonnie Darves

SEATTLE, WA -- September 14, 2006 -- Administering an infusion of the drug nesiritide just before bolus dosing of furosemide may mitigate the risky aldosterone level increases that typically occur in the first few hours after the furosemide is administered.

The drug nesiritide, a natriuretic peptide, was shown in previous studies to reduce the breathing difficulties and elevated wedge pressures associated with acute decompensated heart failure (ADHF).

Researchers reported results of the new multicentre trial here at the Heart Failure Society of America 10^th annual scientific meeting (HFSA). The trial compared the effects of nesiritide, furosemide, and the two drugs in combination in 28 outpatients with stable New York Heart Association Class II or III heart failure who were attending a metabolic unit and were on standard diuretic therapy (furosemide 80 to 240 mg/day).

The study, led by Domenic Sica, MD, professor of internal medicine and nephrology, Virginia Commonwealth University, Richmond, Virginia, had a randomized, 3-way crossover design. Patients received nesiritide alone 2 mcg/kg bolus, 0.01mcg/kg/min for 6 hours, furosemide alone 40 mg IV bolus, or the two drugs combined.

Patients were 82% male, had a mean age of 54 years and a mean weight of 106 kg. Most were taking other medications, commonly beta-blockers and/or angiotensin-converting enzyme inhibitors, as well as digoxin, statins and aspirin. Furosemide was the only diuretic allowed during the study period.

Results show that plasma aldosterone levels decreased by 2.8 ng/dL 2 hours post-dose with nesiritide alone compared with a mean increase of 2.2-ng/dL among patients who received furosemide alone.

Blood pressure levels did not change significantly in any treatment group.

The primary adverse event in the nesiritide plus furosemide patients included headache and dizziness, both of which affected 8 patients.

The researchers acknowledged the study's limitations, chiefly that participants were not acutely compensated clinically at the time of the study, nor did they have intravascular-volume overload. They suggest that nesiritide should be studied further in patients with clinically confirmed acute decompensated heart failure to determine whether the benefits seen in this study persist.

The trial was sponsored by Scios, Inc.


[Presentation title: Nesiritide Appears to Inhibit the Rise in Plasma Aldosterone Associated With Furosemide Diuresis. Poster 275]

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