Background: Nesiritide is indicated in the treatment of acute decompensated heart failure. However, a recent meta-analysis reported that nesiritide may be associated with an increased risk of death. Our goal was to evaluate the impact of nesiritide treatment on four outcomes among adults hospitalized for congestive heart failure (CHF) during a three-year period.
Methods: CHF patients discharged between 1/1/2002 and 12/31/2004 from the Adventist Health System, a national, not-for-profit hospital system, were identified. 25,330 records were included in this retrospective study. Nesiritide odds ratios (OR) were adjusted for various factors including nine medications and/or an APR-DRG severity score.
Results: Initially, treatment with nesiritide was found to be associated with a 59% higher odds of hospital mortality (Unadjusted OR=1.59, 95% confidence interval [CI]: 1.31-1.93). Adjusting for race, low economic status, APR-DRG severity of illness score, and the receipt of nine medications yielded a nonsignificant nesiritide OR of 1.07 for hospital death (95% CI: 0.85-1.35). Nesiritide was positively associated with the odds of prolonged length of stay (all adjusted ORs ≥ 1.66) and elevated pharmacy cost (all adjusted ORs > 5).
Conclusions: In this observational study, nesiritide therapy was associated with increased length of stay and pharmacy cost, but not hospital mortality. Randomized trials are urgently needed to better define the efficacy, if any, of nesiritide in the treatment of decompensated heart failure.
Congestive heart failure (CHF) is a significant public health concern and pressing public policy issue. With greater than 5 million patients who carry the diagnosis of CHF in the United States alone, and with approximately 550,000 new cases per year, it is no surprise that acute decompensated heart failure (ADHF) is the leading cause of hospitalization in the U.S. in persons over the age of 65 years [1,2]. Hospital discharges for CHF rose from 377,000 in 1979 to 970,000 in 2002, an increase of 157%. In 2005 it is estimated that $27.9 billion will be spent on direct costs for CHF, $14.7 billion on hospital care, and $2.9 billion on drugs/other medical durables . With hospital readmission rates as high as 50% at six months, and with the major medical society guidelines focused on the outpatient management of CHF, physicians are always looking for innovative approaches as well as guidance on how to best manage patients with ADHF [3-5].
In 2001 nesiritide (Natrecor ├é┬«) was approved by the FDA for the intravenous treatment of patients with ADHF who have dyspnea at rest or with minimal activity, based on data which showed nesiritide reduced pulmonary capillary wedge pressure and improved dyspnea . Given the plausible biological mechanism of action of nesiritide and its safety profile as compared to existing intravenous inotropic agents, nesiritide use rapidly increased [7-9]. However, two recent publications have questioned the safety of nesiritide in terms of increased mortality and worsening renal function in patients treated with this drug for acutely decompensated heart failure [10, 11]. At one point physicians at the Cleveland Clinic, one of the nation’s largest cardiac centers, considered severely curtailing or even banning the clinic’s use of nesiritide . Subsequently, a panel of cardiologists and heart failure experts was convened, chaired by Dr. Eugene Braunwald, to review the data associated with nesiritide and made recommendations on its use. Reviewing the published data along with other information available on nesiritide, the panel recommended strictly limiting the use of nesiritide to patients presenting to the hospital with ADHF who have dyspnea at rest, and recommend continued enrollment in ongoing trials of nesiritide, as well as pro-active educational programs to inform physicians regarding conditions and circumstances in which nesiritide should and should not be used .
Adventist Health System (AHS) is a multi-hospital, not-for-profit, health care system with community hospitals in many geographic locations. It has over 8,000 admissions per year for CHF. Given the volume of patients seen for CHF and the exponential growth in the use of nesiritide at our facilities, we decided to review our data over a three year period (2002 to 2004; representing more than 25,000 patient encounters) looking specifically at both the clinical outcomes and financial impact of nesiritide use./>/>/>/>/>
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