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news.Johnson & Johnson has said its subsidiary Scios has reported that a phase II study of the heart failure therapy Natrecor was not successful in treating patients with advanced heart failure receiving infusions outside of hospital.
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The phase II trial was designed to assess the long-term safety and outcomes at six months of once or twice weekly infusions of Natrecor compared to placebo in persistently symptomatic advanced chronic decompensated heart failure (CDHF) patients.
Scios said the study showed a neutral effect on the primary endpoint, a composite of death and cardiorenal hospitalization at 12 weeks. However Scios said the study did provide important renal and mortality safety data on Natrecor.
Natrecor is the only FDA-approved intravenous treatment for patients with acutely decompensated congestive heart failure (ADHF) who have shortness of breath at rest or with minimal activity.
In the study there was no statistically significant difference in the primary endpoint between patients receiving Natrecor compared to patients receiving placebo infusions when each was added to optimal heart failure medications, significant use of indicated heart failure devices and intensive disease management.
In previous clinical trials Natrecor was shown to significantly reduce pulmonary capillary wedge pressure and improve patient-reported dyspnea, an important symptom to relieve in patients with exacerbations of heart failure.