FREMONT, Calif., Sept. 1 /PRNewswire/ -- Scios Inc. today announced the
publication of results from a multi-center clinical study of the safety and
tolerability of intravenous (IV) infusions of NATRECOR(R) (nesiritide) in
advanced decompensated congestive heart failure patients in an outpatient
setting. The results of the FUSION I (Follow Up Serial Infusions Of NATRECOR)
study, a controlled study of outpatient IV infusion therapy conducted in heart
failure patients, were published today in the September 1, 2004 issue of The
American Journal of Cardiology.
According to the American Heart Association Heart Disease and Stroke
Statistics -- 2004 Update, congestive heart failure affects more than 5
million Americans. It is estimated that the cost of treating congestive heart
failure patients in the U.S. will reach $28.8 billion in 2004.
Study Details and Results
FUSION I was a multi-center (46 U.S. sites), randomized, open-label, pilot
safety study of 210 advanced decompensated congestive heart failure patients
at high risk for rehospitalization. Patients were randomized to receive either
standard care (usual long-term cardiac medications with or without IV
inotropes) or infusions of NATRECOR at dosages of 0.005 or 0.01 mcg/kg/min (in
addition to their usual long-term cardiac medications, excluding IV inotropes)
for 12 weeks. Based on patient symptoms, the infusion frequency could vary
from once every other week to twice a week.
Patients were further classified as low risk or high risk based on seven
clinical criteria (patients with four or more of these criteria were
considered high risk). All patients had weekly outpatient visits for 12 weeks.
NATRECOR infusions took place over four to six hours. Patients were observed
for an additional period of four weeks after completion of the three-month
treatment period.
The incidence of adverse events through 12 weeks was similar in the three
groups, and no adverse event occurred significantly more frequently in the
patients treated with NATRECOR. Less than one percent (11 of 1645 infusions)
of NATRECOR infusions were discontinued during a study visit due to side
effects.
Through week 12, 48 percent of NATRECOR and 58 percent of standard care
patients, either died or were hospitalized (p=0.185). Through the same period,
six percent of NATRECOR and 10 percent of standard care patients died
(p=0.314); 46 percent of NATRECOR and 54 percent of standard care patients
were hospitalized (p=0.378). Within the higher risk stratum, patients treated
with NATRECOR had a statistically significant reduction in death and
hospitalization (52 vs. 78 percent; p=0.038) and in the number of days that
patients were alive and out of the hospital (77 vs. 67 days; p=0.027) compared
to standard care. Within the higher risk stratum, 5 percent of NATRECOR
patients and 17 percent of standard care patients died (p=0.079) through week
12.
"Caring for heart failure patients places an enormous burden on our
nation's hospitals, and a disproportionate share of that burden is caused by
those patients with advanced disease. FUSION is investigating precisely this
patient population," said Clyde W. Yancy, M.D., Professor of Medicine &
Cardiology, Director of Congestive Heart Failure/Heart Transplant Program at
the University of Texas Southwestern Medical Center, Dallas, and principal
investigator of the FUSION study. "Based on these peer-reviewed results and
initial observations, we are now conducting the FUSION II study to further
explore whether once or twice weekly infusions of nesiritide in the outpatient
setting have the potential to reduce mortality and rehospitalization."
About Decompensated Congestive Heart Failure
Congestive heart failure is characterized by a progressive loss in the
heart's ability to pump blood. Since a weak heart does not pump fluid very
well through the body, fluid can back up and "pool" in the lungs causing
shortness of breath or can accumulate in the ankles causing swelling. This is
why heart failure is often called "congestive" heart failure, or CHF. The term
"decompensated" is a medical term used to describe patients with these
symptoms.
About NATRECOR
NATRECOR(R) (nesiritide) is indicated for the treatment of acutely
decompensated congestive heart failure in patients with dyspnea (shortness of
breath) at rest or with minimal activity. Administered intravenously, NATRECOR
is a recombinant form of human B-type natriuretic peptide (hBNP), a naturally
occurring peptide produced by the heart. In clinical trials, NATRECOR caused
arteries and veins to dilate, alleviating symptoms in patients with acutely
decompensated congestive heart failure by improving circulation, without
increasing heart rate or interfering with heartbeat regularity.
NATRECOR may cause hypotension. If hypotension occurs during
administration of NATRECOR, the dose should be reduced or discontinued, and
blood pressure should be monitored closely. At the recommended dose of
NATRECOR, the incidence of symptomatic hypotension (4 percent) was similar to
that of IV nitroglycerin (5 percent). Asymptomatic hypotension occurred in 8
percent of patients treated with either drug. The mean duration of symptomatic
hypotension was longer with NATRECOR than IV nitroglycerin (2.2 versus 0.7
hours, respectively). NATRECOR may affect renal function in susceptible
patients. 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. Other adverse events reported
at a rate of at least 5 percent during the first 24 hours of infusion with
either NATRECOR plus standard care or IV nitroglycerin plus standard care
therapy, included, respectively: ventricular tachycardia (3 percent, 5
percent), nonsustained ventricular tachycardia (3 percent, 5 percent),
headache (8 percent, 20 percent), abdominal pain (1 percent, 5 percent), and
nausea (4 percent, 6 percent). Higher doses of NATRECOR increased the risk of
hypotension and elevated creatinine. NATRECOR should be avoided as primary
therapy in patients with cardiogenic shock, systolic blood pressure <90 mm Hg,
or in patients with low cardiac filling pressures. Please refer to
http://www.NATRECOR.com for full prescribing information.
About Scios Inc.
Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company
headquartered in Fremont, California. Scios is developing novel treatments for
cardiovascular disease, inflammatory disease and cancer. 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 http://www.sciosinc.com.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Chris B. Ernst of Scios Inc.,
+1-415-710-9445; or Karin Bauer Aranaz of WeissCom Partners,
Inc., +1-415-859-3414, for Scios Inc.
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