ASCEND-HF study showed that Natrecor demonstrated no difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalisations and death during the first 30 days following treatment.
Importantly, the study reinforced the safety profile of Natrecor, revealing no excess adverse effects on renal function or mortality.
Natrecor is approved for use by the US Food and Drug Administration (FDA) for the treatment of patients with acutely decompensated heart failure who experience dyspnea (shortness of breath) at rest or with minimal activity with proven efficacy impact at three hours.
Scios initiated the 7,141 patient ASCEND-HF study in 2007 after first seeking the guidance of an expert panel of cardiology and heart failure clinicians chaired by Eugene Braunwald, Harvard Medical School, in response to questions raised in the medical literature about mortality and impaired renal function of patients treated with Natrecor.
Johnson & Johnson Pharmaceutical Research and Development Cardiovascular Development vice president Peter DiBattiste said that the ASCEND-HF trial has answered many scientific questions and has increased their understanding of the safety profile of Natrecor.
Scios is expected to submit the results from ASCEND-HF to the FDA as part of the standard collection of post-marketing drug experience.