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NATRECOR® (nesiritide)
Prescribing Information
Important Safety Information
NATRECOR® Information




Research & Development

Scios is dedicated to changing the way heart failure is treated by supporting the ASCEND-HF trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure).

In June 2007 Scios Inc. Announced Enrollment Of First Patients in ASCEND-HF Trial in Acute Heart Failure

MOUNTAIN VIEW, CA (June 8, 2007) — In June 2007 Scios Inc.  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® (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® for a minimum of 24 hours up to a maximum of seven days, in addition to standard care.

DCRI, the academic clinical research organization within the DTMI at Duke University Medical Center, will collaborate with the Cleveland Clinic Cardiovascular Coordinator Center (C5) in managing the trial.

ClinicalTrials.gov
To find information on the study enter the following in the Study ID field of the Advanced Search function option: NCT00475852

Indication

NATRECOR® (nesiritide) is indicated for the intravenous treatment of patients with acutely decompensated heart failure who have dyspnea (difficulty breathing) at rest or with minimal activity.


Important Safety Information
(Healthcare Professional)

HYPOTENSION

NATRECOR® may cause hypotension and should be administered only in settings where blood pressure can be monitored closely. If hypotension occurs during administration of NATRECOR®, the dose should be reduced or discontinued. At the recommended dose of NATRECOR®, 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® may be prolonged. The mean duration of symptomatic hypotension was longer with NATRECOR® than IV nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR® 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 in patients with a baseline blood pressure <100 mm Hg, and NATRECOR® should be used cautiously in these patients. In earlier trials, when NATRECOR® was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.01 mcg/kg/min infusion, the frequency, intensity, and duration of hypotension were increased. The hypotensive episodes were also more often symptomatic and/or more likely to require medical intervention.

NATRECOR® is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.

RENAL

NATRECOR® 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® 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® and nitroglycerin groups, respectively. When NATRECOR® was initiated at doses higher than 0.01 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 were not increased.

MORTALITY

In 7 NATRECOR® clinical trials, through 30 days, 5.5% in the NATRECOR® treatment group died as compared with 4.3% in the group treated with other standard medications. In 5 clinical trials, through 180 days, 21.5% in the NATRECOR® treatment group died as compared with 20.7% in the group treated with other medications. There is not enough information to know if there is an increased risk of death after treatment with NATRECOR®.

Please click here to see Full Prescribing Information for NATRECOR®.