"Nesiritide Fails to Improve Outcomes for at-Home Heart Failure Patients: Presented at ACC"
By Ed Susman
NEW ORLEANS, LA -- March 29, 2007 -- An attempt to expand use of the heart failure drug nesiritide (Natrecor) from in-hospital use to at-home use failed to show any compared with optimal medical treatment, researchers said here at the 56[th annual scientific sessions of the American College of Cardiology (ACC).
Researchers had hoped to be able to show that patients with severe chronic heart failure -- stage D or chronic decompensate heart failure -- often have to be treated in hospitals, where use of nesiritide has proven successful in overcoming acute symptoms.
"This is the largest heart failure trial to date in patients with stage D heart failure, the least stable of all heart failure patients who are in dire need of novel treatment methods," said Clyde Yancy, MD, medical director, Baylor Heart and Vascular Institute, Baylor University Medical Centre, Dallas, Texas, United States.
"Serial administration of outpatient nesiritide infusions was not shown to be significantly beneficial in the context of excellent care," Dr. Yancy said.
"The lesson learned here is that appropriate use of evidence-based medical and device therapy, as well as avoidance of non-evidence based therapies done in concert with highly sophisticated and rigorous follow up, is beneficial even in advanced disease."
In his presentation on March 25th, Dr. Yancy discussed the results of the Follow-Up Serial Infusions of Nesiritide in Advanced Heart Failure (FUSION II) trial, which tested the benefit of serial administration of nesiritide versus placebo in outpatients with advanced heart failure.
The primary endpoint was all cause mortality and cardiorenal hospitalisations during the 24-week trial period. Of the 306 placebo patients enrolled, 36.8% experienced the primary endpoint compared with 36.7% of the nesiritide patients (P = .79).
When the categories were separated and scrutinised, Dr. Yancy found that 9.6% of the placebo patients died, compared with 9.5% of nesiritide patients (P = .98). He said 33.6% of placebo patients and 32.9% of nesiritide patients required cardiorenal hospitalisation (P = .95).
While the primary results were neutral, Dr. Yancy said it is important to note that there was no evidence of renal harm or excess mortality attributed to nesiritide. "I would not say flat out that nesiritide is safe, but we did not see any evidence of a renal signal in this study. So that is encouraging."
Nesiritide, a recombinant human B-type natriuretic peptide, is approved in the United States for treatment of acute decompensated heart failure, but questions have been raised regarding its safety. Currently, it is primarily administered to hospitalised patients, but Dr. Yancy and colleagues tested the potential benefit and safety of outpatient treatment to improve the natural history of chronic decompensated heart failure.
Background therapy was excellent with high compliance regarding standard, evidence-based medical and device therapy, along with an extraordinary program of precise disease management, Dr. Yancy said.
Event rates in FUSION II were 33% lower than that seen in FUSION I, likely due to the excellent background therapy and medical care, Dr. Yancy said
"I think these results rule out home-based therapy with this drug," he said. "However, I don't know what to tell a patient who clearly would need nesiritide who comes into my office in distress but doesn't want to b e hospitalized. We don't have an answer for that as yet."
[Presentation title: Results of the Follow-Up Serial Infusions of Nesiritide for the Management of Patients With Heart Failure (FUSION II) Trial. Abstract 402-9]
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