SUNNYVALE, Calif., Dec. 19 /PRNewswire-FirstCall/ --
Scios Inc. (Nasdaq: SCIO) today announced that an article published in the
most recent issue of the American Heart Journal reports results of a study
demonstrating that Natrecor(R) (nesiritide) is a safe and effective short-term
treatment for patients with acutely decompensated congestive heart failure,
particularly in patients with pre-existing arrhythmias.
The PRECEDENT (Prospective Randomized Evaluation of Cardiac Ectopy with
Dobutamine or Natrecor Therapy) study was designed to compare the safety and
clinical effectiveness of Natrecor and dobutamine in hospitalized patients
with acute heart failure. Specifically, the study focused on prospectively
determining the differential effects of Natrecor and dobutamine on heart rate
and the genesis or aggravation of ventricular arrhythmias.
"The results demonstrate a clinical advantage for Natrecor in reducing the
occurrence of arrhythmias and tachycardia," said Andrew J. Burger, M.D., FACC
of Beth Israel Deaconess Medical Center, Harvard Medical School and lead
investigator of the trial. "This study also further demonstrates the ability
of Natrecor to safely and rapidly relieve symptoms of acute heart failure
without significant complications or adverse effects, and provides additional
evidence to support its use as a first-line therapy for these patients."
In the multi-center, open-label, active-control trial, 255 patients were
randomized to one of two doses of intravenous nesiritide (0.015 or 0.03
mcg/kg/min) or dobutamine (5 mcg/kg/min) and were stratified by means of an
earlier history of ventricular tachycardia. Patients were also assessed with
24-hour Holter monitor recordings immediately before and during study drug
therapy and by means of signs and symptoms of heart failure.
The results demonstrated that dobutamine exhibited substantial
proarrhythmic and chronotropic effects in patients with no existing arrhythmia
and with pre-existing arrhythmia, whereas nesiritide actually either reduced
these effects or had a neutral effect. The results demonstrated that
dobutamine significantly increased the mean number of ventricular tachycardia
events per 24 hours by 8 +/- 205 (p = 0.001); repetitive ventricular beats per
hour by 15 +/- 53 (p = 0.001); premature ventricular beats per hour by
69 +/- 214 (p = 0.006), and heart rate by 5.1 +/- 7.7 beats per minute
(P < 0.001). The most common cardiovascular adverse event associated with
nesiritide was dose-related hypotension (i.e., reduction of blood pressure),
which occurred more frequently in the nesiritide-treated group than in the
dobutamine-treated group (p < 0.001).
About Natrecor
Natrecor is indicated for the treatment of acutely decompensated heart
failure in patients with dyspnea (shortness of breath) at rest or with minimal
activity. Administered intravenously, Natrecor is a recombinant form of
B-type natriuretic peptide (hBNP), a naturally occurring hormone in the body
that promotes healthy functioning of the heart. Natrecor has novel properties
that cause arteries and veins to dilate, alleviating symptoms in patients with
acute heart failure by improving blood movement around the heart, yet without
increasing heart rate or interfering with heartbeat regularity.
About Scios
Scios is a biopharmaceutical company 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.
Forward-Looking Safe Harbor Statement
This news release contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. We generally identify such forward-looking statements
using words like "believe," "intend," "expect," "may," "should," "plan,"
"project," "contemplate," "anticipate" or similar statements. Statements that
are not historical facts are forward-looking statements based on current
assumptions that involve risks and uncertainties. These risks and
uncertainties may include the sales penetration and success of Natrecor, the
success of clinical trials of Natrecor and our pipeline products, including
SCIO-469, as well as other risks detailed from time to time in the reports
filed by Scios with the SEC, including the Company's quarterly reports and
annual report on Form 10-K. Actual results, performance or achievements of
Scios may differ significantly from those described in these forward-looking
statements. Scios disclaims any intention or obligation to update or revise
any financial projections or forward-looking statements, whether as a result
of new information, future events or otherwise.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Media and Investors, Suzanne Beveridge of
Scios Inc., +1-408-616 2947; or Media, Jim Weiss of WeissCom
Partners, Inc., +1-415-260-1274, or Investors, or Fern Lazar or
Sara Moorin, both of Lazar Partners Ltd., +1-212-867-1762, all
for Scios Inc.
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