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Increased Serum Creatinine More Likely when Nesiritide is Combined with High-Dose Diuretics: Presented at AHA

By Jill Stein

DALLAS, TX -- November 16, 2005 -- Patients with acute decompensated heart failure who receive nesiritide plus high-dose diuretics have an increased risk of serum creatinine elevations, according to data reported here at the American Heart Association's Scientific Sessions 2005 (AHA).

J. Thomas Heywood, MD, Director, Heart Failure Program, Scripps Clinic in La Jolla, California, United States, presented the data in a presentation on November 14^th.

Dr. Heywood and colleagues determined the relative risk of increased serum creatinine for nesiritide compared to nitroglycerin in heart failure patients being treated with high-dose diuretics.

For the analysis, he used data from the Vasodilatation in the Management of Acute Congestive HF (VMAC) trial, in which patients were randomized to nesiritide or nitroglycerine.

All subjects in the VMAC trial had acute decompensated heart failure and dyspnea at rest or with minimal activity (such as talking, eating, or bathing) despite the use of standard medical therapies.

High-dose diuretic use was defined as a maximum daily dose of furosemide 160 mg or greater, bumetanide 4 mg or greater, torsemide 80 mg or greater, metolazone 10 mg or greater, chlorothiazide 1000 mg or greater, and hydrochlorothiazide 50 mg or greater, or concurrent treatment with two or more of these diuretics irrespective of dose.

Of 489 subjects, evaluable serum creatinine data were obtained for 268 subjects in the nesiritide and 212 in the nitroglycerine group. Of these patients, 137 patients on nesiritide and 117 nitroglycerine patients received high-dose diuretics.

The rates of serum creatinine increases greater than 0.5 mg/dL from baseline through day 30 were calculated in patients who received high-dose diuretics and in patients who received low- or moderate-dose diuretics.

The risk of a serum creatinine increase greater than 0.5 mg/dL was not affected by vasodilator type in the low- to moderate-dose diuretic group.

However, the risk of serum creatinine increase greater than 0.5 mg/dL was significantly higher with nesiritide in the high-dose diuretic group compared to those who were not on high-dose diuretics (20.5% vs. 34.3%; risk ratio =1.6, P = .02).

Dr. Heywood said that the fact that there have been no randomized clinical outcome or dose-relationship studies of loop diuretics for the treatment of acute decompensated heart failure represents a possible study limitation.

He also noted that the mechanism for the increased risk of elevated serum creatinine with the combination of nesiritide and high-dose diuretics is not clear.

Prospective trials are needed to identify the optimal use of nesiritide plus diuretics, he added.


[Presentation title: Combining Nesiritide With High-Dose Diuretics May Increase the Risk of Increased Serum Creatinine. Abstract 2180]

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