Results Show Lower Health-Care Resource Use
ORLANDO, Fla. and FREMONT, Calif., Nov. 11 /PRNewswire/ -- Scios Inc.
today announced the presentation of positive clinical data from an
investigator-sponsored study that shows an association between the use of
Natrecor(R) (nesiritide) and fewer complications, significantly less
health-care resource use, and lower hospital costs for patients with acute
decompensated heart failure. The results were presented today at the American
Heart Association's Scientific Sessions 2003 taking place this week in
Orlando, Florida.
A net cost savings of $1446 per patient was demonstrated with acute heart
failure patients who received nesiritide, compared to patients who did not
receive the drug. Savings included the cost of nesiritide. In addition, when
nesiritide was administered to acute heart failure patients via continuous
infusion for at least 12 hours within the first 48 hours of hospital
admission, patients' critical care length of stay dropped by almost a day.
Patients who received nesiritide also used less potassium, less intravenous
(IV) inotropic agents, and less IV vasodilator drugs. Fewer heart and kidney
complications were also observed in the group of patients who received
nesiritide.
"There are an estimated 1-3 million hospitalizations in the U.S. each year
related to congestive heart failure, making heart failure the most costly
Medicare expense in the country," said Daniel Hilleman, Pharm.D., professor at
Creighton University Schools of Medicine and Pharmacy and the principal
investigator of the independent study. "If we can significantly reduce
health-care resource use with nesiritide, we can reduce the burden of heart
failure patients on the health-care system."
About the Pharmacoeconomic Study
The study, titled Pharmacoeconomic Analysis of Nesiritide Use in
Decompensated Heart Failure (Abstract #2535), was a multi-center (9 U.S.
sites) study of 216 patients who had been hospitalized for acute heart failure
in the past year. The analysis included 108 patients who had received
nesiritide and 108 patients who had received standard care without nesiritide.
Use of health-care resources, frequency of heart and kidney complications and
costs of hospitalization were compared between the two groups.
Hospitalization costs were $11,310 per patient in the non-nesiritide group
and $9,864 in the group that received nesiritide (p=0.027). The net
hospitalization cost savings in acute heart failure patients who received
nesiritide, including the cost of nesiritide, was $1446 per patient compared
to the non-nesiritide group.
Acute heart failure patients who received nesiritide within 48 hours of
hospital admission and continued infusion for at least 12 hours used
significantly less health-care resources than patients who did not receive the
drug. This included a shorter critical care length of stay (-22.7 hrs;
p=0.03), lower numbers of per os (p.o.) potassium doses (-2.2 doses; p=0.09),
and less intravenous (IV) inotropic agent and IV vasodilator drug use
(dobutamine 33% vs. 54%; p=0.03; dopamine 33% vs. 50%; p=0.03; milrinone 9%
vs. 18%; p=0.02; IV nitroglycerin 18% vs. 71%; p=0.01).
Fewer heart and kidney complications were observed in the group of acute
heart failure patients who received nesiritide than in the non-nesiritide
group (atrial fibrillation, 19% vs. 35%; p=0.03; renal dysfunction, 26% vs.
37%; p=0.04).
About Acute Heart Failure
During an episode of acute heart failure, the heart's ability 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 severe enough that only intravenous
medications administered in the hospital can improve a patient's condition.
More than one million hospitalizations of patients with acute congestive
heart failure as a primary diagnosis occur in the United States each year.
This translates into a health-care system cost of $15 billion. Another two
million Americans are hospitalized annually with acute 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(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 recombinantly produced 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
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 markets with unmet medical needs.
AHA Program # 2535/C88, Tuesday, November 11, 2003, 9:30 - 11:00 a.m. in
Hall A.
SOURCE Scios Inc.
 back to top
Related links:
http://www.natrecor.com
CONTACT:
Chris L. Bing of Scios Inc., +1-415-710-9445;
or Karin Bauer Aranaz of WeissCom Partners, Inc.,
+1-415-859-3414, for Scios
|
