Results Also Demonstrate Positive Clinical Outcomes
LAS VEGAS, and FREMONT, Calif., Sept. 23 /PRNewswire/ -- Scios Inc. today
announced positive results from its Follow Up Serial Infusions Of Natrecor(R)
(FUSION) I pilot trial designed to evaluate the safety and tolerability of
weekly infusions of Natrecor(R) (nesiritide) when administered in an
outpatient setting to patients with advanced chronic congestive heart failure
(CHF) who are at high risk for hospitalization. The results were presented
today at the 7th Annual Scientific Meeting of the Heart Failure Society of
America taking place this week in Las Vegas.
An estimated five million Americans suffer from congestive heart failure,
with 550,000 new cases diagnosed annually. Natrecor is a recombinant form of
human B-type natriuretic peptide (hBNP), a hormone secreted by the heart in
response to heart failure. Currently, Natrecor is being widely used to treat
patients hospitalized with acutely decompensated CHF with dyspnea (shortness
of breath) at rest or with minimal physical activity.
"Evidence from this initial FUSION study suggests that weekly outpatient
infusions of Natrecor can be safely administered to treat high-risk patients
with advanced CHF," said Clyde W. Yancy, M.D., Associate Professor of Medicine
& Cardiology, Director of Congestive Heart Failure/Heart Transplant Program at
UT Southwestern Medical Center, Dallas, and investigator in the FUSION I
trial. "Moreover, if we can replicate the benefits observed in FUSION I on
clinical outcomes such as mortality and hospitalizations in a larger trial,
Natrecor has the potential to become an effective outpatient treatment for
hundreds of thousands of patients with advanced, chronic heart failure. We
look forward to bearing that out with further study."
Data from the FUSION I study suggests that the Natrecor-treated patients
showed improvements in clinical status with longer life expectancy and a lower
frequency of hospitalizations compared with the group of patients receiving
standard care. Based upon the data generated from FUSION I, Scios will seek
to initiate a larger study designed to assess the efficacy of serial
outpatient infusions of Natrecor for several months to reduce death and
hospitalizations in patients with chronic advanced CHF who are at high risk
for hospitalization.
"The FUSION I trial provides compelling data to support the further study
of Natrecor in the outpatient setting for the treatment of patients with
advanced CHF," said Darlene P. Horton, M.D., Scios' senior vice president of
clinical research and medical affairs. "We believe Natrecor holds enormous
potential to help clinicians treat their high risk CHF patients in a more
convenient and cost-effective manner than hospitalization."
About the FUSION Trial
FUSION I was a multi-center (46 U.S. sites), randomized, three-treatment
arm, open-label, pilot study of 210 chronic 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 serial infusions of either 0.005 or 0.01 mcg/kg/min of Natrecor
(in addition to their usual long-term cardiac medications, excluding IV
inotropes). Patients were further classified as low or high risk based on
seven criteria (patients with four or more of these criteria were considered
high risk). All patients had weekly outpatient visits for 12 weeks and
Natrecor patients received a four to six hour infusion at each weekly visit.
Patients were observed for an additional period of four weeks after completion
of the three-month treatment period.
The results of the trial showed that weekly outpatient infusions of
Natrecor for 12 weeks were well tolerated. The incidence of adverse events
through 12 weeks was similar in the three groups, and no adverse event
occurred significantly more frequently in the Natrecor groups. Less than one
percent (11 of 1645 infusions) of Natrecor infusions were discontinued during
a study visit due to side effects; two patients discontinued Natrecor
infusions due to symptomatic hypotension. 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 (83 vs. 77 days; p=0.027). Within the higher risk stratum through
week 12, five percent of Natrecor patients and 17 percent of standard care
patients died (p=0.079).
About Acute Heart Failure
During an episode of acute heart failure, the heart's inability to
circulate blood adequately throughout the body worsens to the point where
hospitalization is necessary to stabilize the patient's condition. A sudden
increase in salt in a person's diet, a patient's failure to take prescribed
oral medications or the development of a new heart problem can cause these
acute episodes. Virtually all congestive heart failure patients will
experience at least one acute episode, in which the symptoms become so severe
that only intravenous medications administered in the hospital can improve a
patient's condition.
More than one million hospitalizations occur in the United States each
year for congestive heart failure as the primary diagnosis, with a cost to the
health-care system of $15 billion. Another two million Americans are
hospitalized annually with congestive heart failure as a secondary diagnosis.
Congestive heart failure accounts for the greatest number of hospitalizations
of patients over the age of 65.
About Natrecor
Natrecor 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 protein in the body. In clinical trials, Natrecor caused arteries
and veins to dilate, alleviating symptoms in patients with acutely
decompensated congestive heart failure by improving blood movement around the
heart, yet 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 the 30-day follow-up period in the VMAC
(Vasodilation in the Management of Acute Congestive Heart Failure) trial, five
patients in the IV nitroglycerin group (2 percent) and nine patients in the
Natrecor group (3 percent) required first-time dialysis. 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 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.
Scios Inc.
Scios, a Johnson & Johnson company, is a biopharmaceutical company of more
than 500 people headquartered in Fremont, California. Scios is developing
novel treatments for cardiovascular and inflammatory 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 for large markets with unmet medical needs.
SOURCE Scios Inc.
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http://www.sciosinc.com
CONTACT:
Jim Weiss or Rick Roose of WeissCom Partners,
Inc., +1-415-362-5018, for Scios Inc.; or Sara Moorin of Lazar
Partners, Inc., +1-212-867-1773, or +1-917-716-7714
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