SAN FRANCISCO, CA—Nesiritide had no effect on renal function and was not associated with worse clinical outcomes in patients with acute decompensated heart failure (ADHF), according to results of a retrospective analysis of the ASCEND-HF trial presented at ACC.13, the American College of Cardiology’s 62nd Scientific Session.
The analysis was conducted to determine whether nesiritide, a recombinant B-type natriuretic peptide with vasodilatory properties, had a possible role in renal toxicity and mortality, said lead study author Vincent M. van Deursen, MD, of the University Medical Centre Groningen, Groningen, The Netherlands.
Dr. van Deursen and colleagues evaluated prevalence and predictors on changes in renal function, association of changes in renal function with clinical outcome, and the effects of nesiritide on renal function.
In ASCEND-HF, 7,141 patients hospitalized with ADHF were randomized to receive either nesiritide or placebo for 24-168 hours in addition to standard of care. “Worsening in renal function” was defined as an increase of serum creatinine of >0.3mg/dL and >25% during hospitalization. Clinical events were the separate and combined end points of death from any cause and rehospitalization for heart failure at 30 days.
In this analysis of 4,708 patients, median baseline creatinine was 1.2mg/dL (range 1.0-1.6), which decreased slightly to a median of 1.1mg/dL (range 0.9-1.5) during hospitalization. Similarly, a slight decrease was seen in the median baseline BUN 25 units (range 18-38) to 24 units (range 7-36) during hospitalization. Changes in both serum creatinine and BUN were similar in nesiritide and placebo-treated patients (P=0.2029 and P=0.4117, respectively).
The frequency of worsening renal function during hospitalization was similar in the nesiritide and placebo group (14.1% and 12.8%, respectively, odds ratio with nesiritide 1.12 [0.95-1.32], P=0.19), and was not associated with rehospitalization or death at 30 days.
However, both baseline creatinine and creatinine at discharge were associated with death or hospitalization (both P<0.001), with the stronger relationship associated with the discharge value (Chi-square 61 vs. 41 for mortality; 118 vs. 108 for the combined endpoint, respectively.
Dr. van Deursen concluded that although nesiritide did not affect renal function, both baseline and discharge renal function were associated with a higher 30-day mortality and re-hospitalization, “while changes in renal function and worsening renal function were not.”