The FINANCIAL — Scios Inc. announced on November 14 that the landmark investigational study of NATRECOR (nesiritide) for the treatment of acutely decompensated heart failure (ADHF), ASCEND-HF, demonstrated no statistically significant difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalizations 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 U.S. 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.1 Scios initiated the 7,141 patient ASCEND-HF study (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) in 2007 after first seeking the guidance of an expert panel of cardiology and heart failure clinicians chaired by Eugene Braunwald, M.D., 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 informed.
“The ASCEND-HF trial has answered many scientific questions and has increased our understanding of the safety profile of NATRECOR,” said Peter M. DiBattiste, M.D., Vice President of Cardiovascular Development at Johnson & Johnson Pharmaceutical Research and Development, L.L.C. “This is the largest trial ever conducted in patients with ADHF, and affirms our commitment to patients and physicians who have limited treatment options to fight this life threatening disorder.”
The results from ASCEND-HF will be submitted to the FDA as part of the standard collection of post-marketing drug experience.
Adrian F. Hernandez, M.D. MHS, Associate Professor, Duke Clinical Research Institute, presented the results during a late-breaking clinical trial presentation during the Scientific Sessions of the American Heart Association.
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