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Promising New Treatment for Acute Congestive Heart Failure Reviewed In Journal of Cardiac Failure

Studies Involving Over 1,700 Patients Demonstrate Nesiritide Rapidly Improves
                 Blood Circulation, Relieves Patient Symptoms

    BOSTON, March 20 /PRNewswire/ -- A promising investigational drug called
nesiritide may become a useful new treatment for the one million Americans
hospitalized each year with acute congestive heart failure (CHF), according to
a comprehensive review article published in this week's issue of the Journal
of Cardiac Failure.
    The article reviews results of clinical trials involving more than
1,700 acute CHF patients and concludes that nesiritide (Natrecor(R),
Scios, Inc. (Nasdaq:  SCIO), Sunnyvale, Calif.) rapidly improves blood
circulation and alleviates symptoms associated with acute CHF, such as
shortness of breath and fatigue.  Nesiritide is a recombinant form of B-type
natriuretic peptide (BNP), a naturally occurring hormone in the body that aids
healthy functioning of the heart.  It causes arteries and veins to dilate,
alleviating symptoms by improving blood movement around the heart without a
change in heart rate.  Nesiritide is administered intravenously in a standard
fixed dose regimen, and does not require titration (i.e., dose adjustments).
    "The impressive amount of data collected, analyzed and presented to date
indicate that nesiritide improves symptoms, is well-tolerated and would be a
valuable addition to the initial treatment of patients admitted to the
hospital for acute decompensated CHF," said the article's author, Wilson S.
Colucci, M.D., Professor of Medicine and Physiology and Cardiovascular
Medicine, Boston University School of Medicine.  "The drug's salutary clinical
and hemodynamic profile, rapid onset of action, ease of administration and
favorable safety profile circumvent several of the limitations we have with
currently available treatments."
    Nesiritide is currently being reviewed by the U.S. Food and Drug
Administration and, if approved, would be the first new treatment for acute
CHF in more than a decade.
    The article examines several studies, including the recently completed
498-patient VMAC (Vasodilation in the Management of Acute Congestive heart
failure) trial, which demonstrated that nesiritide, added to standard care,
had a statistically significant effect on the primary endpoint, reducing
pulmonary capillary wedge pressure (PCWP), a measure of the pulmonary
congestion resulting from acute CHF, in as little as 15 minutes.  This effect
was sustained for at least 48 hours.  At three hours, nesiritide plus standard
care significantly improved PCWP, compared to either the placebo plus standard
care or intravenous (IV) nitroglycerin plus standard care regimens.
Nesiritide also significantly improved patient breathing compared to the
placebo plus standard care regimen, and produced a more rapid improvement in
patient hemodynamics and caused significantly fewer side effects than the IV
nitroglycerin regimen.
    In the first three hours of the VMAC trial, 5% of the Natrecor patients
reported headache, vs. 12% for IV nitroglycerin.  In the first 24 hours of the
trial, 9% of the Natrecor patients reported headache, vs. 20% for
nitroglycerin.  Symptomatic hypotension was reported in 4% of the Natrecor
patients and 5% of the nitroglycerin patients.
    Another recent study discussed in the article is the PRECEDENT
(Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or
Nesiritide Therapy) trial, which showed that nesiritide produced fewer
arrhythmias (irregular heart beats) and improved overall mortality rates
compared to dobutamine, a commonly administered inotropic agent.  The other
studies reviewed in the article were published in the July 27th issue of The
New England Journal of Medicine.  In those studies, infusion of nesiritide in
acute CHF patients resulted in significant improvements in hemodynamic
function (i.e., blood circulation forces), including an increase in the
cardiac index, and rapid and sustained improvements in clinical status.

    Congestive Heart Failure - An Epidemic
    A potentially life-threatening disorder that has no cure, heart failure
usually develops gradually over time, and is becoming more prevalent as the
population ages.  In heart failure, the heart functions inefficiently
and circulation is reduced to the body's organs.  In congestive heart failure,
fluid accumulates in the tissues, including lung tissue, causing such symptoms
as difficulty breathing, swelling of the hands and feet, difficulty sleeping,
dry cough, fatigue and rapid weight gain.  CHF may result from an acute event
(e.g., heart attack), where a patient survives but with a weakened heart.
    During an acute episode of CHF, the heart's inability to adequately
circulate blood throughout the body worsens beyond its already compromised
state, causing symptoms to become so pronounced that hospital treatment is
required to stabilize the patient's condition.  A sudden increase in dietary
sodium (salt), failure to take chronic oral medications for managing CHF, or
the development of a new heart arrhythmia can precipitate an acute attack.
    Roughly five million Americans suffer from heart failure, and there are
approximately one million hospitalizations each year in the U.S. for CHF which
cost the healthcare system $23 billion. Another two million Americans are
hospitalized each year with CHF as the secondary diagnosis.  In the U.S., CHF
accounts for the largest cause of hospitalizations for patients over age 65.
Virtually all CHF patients will have at least one acute episode, where the
symptoms are so severe that often only intravenous (IV) medications
administered in the hospital can improve patients' health.
    Boston University Medical Center is composed of the Boston University
Schools of Medicine, Public Health, and Dental Medicine and Boston Medical
Center.  With more than 2,000 physicians and researchers on its staff, Boston
University Medical Center is a nationally-recognized leader in cardiovascular
medicine, cancer, trauma, Parkinson's disease, arthritis, infectious diseases
including AIDS, and spinal cord injuries.


SOURCE Boston University School of Medicine




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CONTACT:
Gina DiGravio, 617-638-8491, for the Boston
University School of Medicine