MOUNTAIN VIEW, Calif., June 8 /PRNewswire/ -- Scios Inc. today announced enrollment of the first patients in ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure), a trial which will involve heart failure experts and practitioners at approximately 600 sites in the United States and throughout the world. ASCEND-HF is being conducted by the Duke Clinical Research Institute (DCRI), and is designed to further assess the long-term clinical outcomes and benefit/risk profile of NATRECOR(R) (nesiritide) in patients with acutely decompensated heart failure (ADHF).
"This landmark, 7,000-patient trial is a major advancement in adding to our collective understanding of ADHF, and it is a real privilege to be able to conduct such a robust study together with academic colleagues around the world," said Robert Califf, M.D., chair of the trial, Director of the Duke Translational Medicine Institute (DTMI) and Vice Chancellor for Clinical Research and Professor of Medicine in the Division of Cardiology at Duke University Medical Center. "Given the fact that nesiritide is one of the few options in relieving the symptoms of these critically ill patients, we have the opportunity to gain a greater understanding of the overall profile of the drug."
In this randomized, double-blind, placebo-controlled, parallel-group, multi-center outcomes trial, approximately 7,000 patients with ADHF will be randomized to receive placebo or NATRECOR(R) for a minimum of 24 hours up to a maximum of seven days, in addition to standard care.
The primary objective of the trial is to assess whether treatment with NATRECOR(R) in addition to standard care, compared with placebo plus standard care, improves patient outcomes, as measured by reduction in the composite of heart failure rehospitalization and all-cause mortality through 30 days; or improves heart failure symptoms, as measured by a patient self-assessed dyspnea, or shortness of breath, scale at six and 24 hours after NATRECOR(R) initiation.
Additional clinical endpoints include measuring improvement in patient self-assessed overall well-being at 6 or 24 hours after NATRECOR(R) initiation; increase in the number of days alive and outside of the hospital at 30 days; and reduction of 30-day composite cardiovascular rehospitalization and cardiovascular mortality.
DCRI, the academic clinical research organization within the DTMI at Duke University Medical Center, will collaborate with the Cleveland Clinic Cardiovascular Coordinating Center (C5) in managing the trial.
NATRECOR(R) Clinical Development Program
The ASCEND-HF trial is part of a robust clinical development program, in which Scios continues to evaluate the efficacy and benefit/risk profile of NATRECOR(R) in ongoing clinical trials designed to study its impact on mortality, as well as kidney and lung function.
"NATRECOR(R) is an important treatment for patients with ADHF, and ASCEND- HF will add to the already extensive body of evidence supporting the safety and efficacy of the drug," said Roger Mills, M.D., Vice President, Medical Affairs at Scios. "Scios has been committed to ADHF patients for more than two decades, and we remain dedicated to investigating and advancing the understanding of ADHF as well as how NATRECOR(R) may impact and improve patient outcomes."
About NATRECOR(R) (nesiritide)
NATRECOR(R) is the only approved treatment for ADHF that has shown improvement in difficulty breathing and reduction of elevated wedge pressures in the lungs in controlled clinical trials. NATRECOR(R) has been studied in 16 prospective clinical trials involving 2,012 patients treated with the drug, and has been used to treat more than 800,000 acutely decompensated heart failure patients. NATRECOR(R) is indicated for the intravenous treatment of patients with ADHF who have dyspnea at rest or with minimal activity. In this population, the use of NATRECOR(R) reduced pulmonary capillary wedge pressure and improved patient reported dyspnea. For full Prescribing Information, visit www.natrecor.com. See Important Safety Information below.
About Scios Inc.
Scios Inc. is a biopharmaceutical company headquartered in Mountain View, California. Scios is developing novel treatments for cardiovascular disease. The company's disease-based technology platform integrates expertise in protein biology with computational and medicinal chemistry to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit www.sciosinc.com.
IMPORTANT SAFETY INFORMATION
NATRECOR(R) (nesiritide) may cause hypotension and should be administered only in settings where blood pressure can be monitored closely. If hypotension occurs during administration of NATRECOR(R) the dose should be reduced or discontinued. At the recommended dose of NATRECOR(R), the incidence of symptomatic hypotension (4%) was similar to that of IV nitroglycerin (5%). Asymptomatic hypotension occurred in 8% of patients treated with either drug. In some cases, hypotension that occurs with NATRECOR(R) may be prolonged. The mean duration of symptomatic hypotension was longer with NATRECOR(R) than IV nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR(R) should not be used in patients with systolic blood pressure <90 mm Hg or as primary therapy in patients with cardiogenic shock. The rate of symptomatic hypotension may be increased with a baseline blood pressure <100 mm Hg, and NATRECOR(R) should be used cautiously in these patients. In earlier trials, when NATRECOR(R) was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.010 mcg/kg/min infusion, the frequency, duration, and intensity of hypotension was increased. The hypotensive episodes were also more often symptomatic and/or more likely to require medical intervention. NATRECOR(R) is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.
NATRECOR(R) may affect renal function in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with NATRECOR(R) may be associated with azotemia. In the VMAC trial, through day 30, the incidence of elevations in creatinine to >0.5 mg/dL above baseline was 28% and 21% in the NATRECOR(R) and nitroglycerin groups, respectively. When NATRECOR(R) was initiated at doses higher than 0.010 mcg/kg/min, there was an increased rate of elevated serum creatinine over baseline compared with standard therapies, although the rate of acute renal failure and need for dialysis was not increased.
In the seven NATRECOR(R) clinical trials, through 30 days, 5.5% in the NATRECOR(R) treatment group died as compared with 4.3% in the group treated with other standard medications. In five clinical trials, through 180 days, 21.5% in the NATRECOR(R) treatment group died as compared with 20.7% in the group treated with other medications. There is not enough information to know about the effect of NATRECOR(R) on mortality.
See full Prescribing Information at www.natrecor.com.