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FUSION II: Nesiritide did not demonstrate clinical benefit in patients with advanced HF
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Outpatient nesiritide infusions did not provide a clinical benefit superior to intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage cardiac death heart failure, according to the results from a recent study.
The researchers from Boston and other sites conducted a randomized, double blind study to examine the effects of nesiritide (Natrecor, Scios Inc.) given as serial outpatient infusions.
Patients (n=911) were randomly assigned nesiritide (2 mg/kg bolus plus 0.01 mcg/kg per minute infusions for four to six hours) or placebo once or twice a week. The study had duration of 12 weeks.
The primary endpoint was time to all-cause death or cardiovascular or renal hospitalization at 12 weeks, according to the researchers. The primary endpoint occurred in 36.8% of the placebo group and in 36.7% of the nesiritide group (HR=1.03; 95% CI, 0.82-1.3).
There were no significant differences for secondary endpoints or adverse events between the two groups, according to the researchers.
“Pending more research, the current goal should be optimization of guideline-driven, evidence-based therapy, with the recognition that even patients with advanced disease may still derive a benefit from further improvements in therapy,” the researchers wrote in a press release. – by Christen Haigh
Circulation: Heart Failure. 2008;1:9-16.
The study was negative. This drug should not be used on outpatients with heart failure. There is much anecdotal support for such a treatment regimen, but in a well designed randomized trial, no benefit could be found. Many people will cite the use of a bolus as a shortcoming, and others will say the study duration was too short. What matters is in a well designed properly powered trial there was no difference when the drug was added to standard HF care.
The practice of outpatient nesiritide should be stopped completely. Even the use of the agent under observational status when the patient is ‘briefly’ admitted should be aggressively reviewed by CMS and other payers. We now have strong evidence that the patients do not benefit and thus the risk/benefit ratio slants toward nesiritide offering only risk when used on an outpatient basis.
– Frank W. Smart, MD
Cardiology Today Editorial Board member