Study Compares Outcomes in Patients Treated with
Nesiritide vs. Inotropic Agents
TORONTO, Canada, Sept. 13 /PRNewswire/ -- An observational study presented
today concluded that nesiritide (Natrecor(R)) was associated with
significantly reduced in-hospital mortality and length-of-stay (LOS) compared
to that of inotropic agents, specifically dobutamine and milrinone, in acutely
decompensated heart failure (ADHF) patients. The study was presented in a
poster session at the Eighth Annual Scientific Meeting of the Heart Failure
Society of America in Toronto, Canada.
"These results display exciting findings regarding the treatment of
patients with acutely decompensated heart failure," said Lindsay M. Arnold,
PharmD, Internal Medicine Clinical Specialist at Boston Medical Center, and
lead investigator of the study. "These findings suggest that nesiritide is
associated with significantly fewer deaths and shorter lengths of stay when
compared to treatment with inotropic agents milrinone and dobutamine. Due to
the retrospective nature of the study and other limitations, a randomized,
controlled investigational study should be undertaken to determine if there is
a causal connection between these findings."
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
The study, "Mortality and Length of Hospital Stay in Patients Receiving
Dobutamine, Milrinone, or Nesiritide for Acute Decompensated Heart Failure"
(HFSA #317), was a retrospective cohort analysis of the University
HealthSystem Consortium (UHC) Clinical Database that consists of 32 academic
health centers. The final cohort included 2,130 acutely decompensated heart
failure patients (dobutamine n=1,311; milrinone n=433; nesiritide n=386). The
mean length of stay (LOS) for patients receiving nesiritide (7.0 +/-5.3 days)
was lower compared to those receiving dobutamine (10.4 +/-12.9 days; p=0.012)
or milrinone (12.2+/- 29.9 days; p<0.001).
In-hospital mortality rates for dobutamine, milrinone, and nesiritide were
10.2%, 7.9%, and 2.9%, respectively. The adjusted odds ratio for death with
dobutamine and milrinone, as compared to nesiritide, were 3.5 and
4.1 (p<0.0001), respectively. Analysis of hospital readmission rates and
healthcare cost is now ongoing.
Chi-square analysis, a test of statistical significance, was used to
evaluate baseline demographic data; logistic regression and multivariate
linear regression were used to assess the relationship of drug therapy to
in-hospital mortality and LOS, respectively. All regression analyses were
completed after controlling for age, gender, and race, region of the country,
primary payer, and UHC severity class. UHC utilizes the Refined DRG Grouper to
assign patient severity.
"These findings are intriguing and add to the growing body of evidence
supporting the use of nesiritide," said Michael Crouch, PharmD, BCPS,
Associate Professor of Pharmacy & Medicine, at Virginia Commonwealth
University School of Pharmacy, and senior author of the study. "The results
suggest patients receiving nesiritide for acute heart failure have a lower
mortality rate and length of hospital stay compared to patients managed with
inotropic agents. However, we were unable to control for important confounding
variables, such as systolic blood pressure, and further investigation is
warranted to confirm these findings."
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 Inotropic Agents
Inotropic agents are a class of drugs that stimulate the heart to contract
more forcefully to pump out more blood. Intravenous inotropic agents are used
to treat patients with severe heart failure marked by a dangerously low output
of blood from the heart.
About NATRECOR(R)
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(R) is a recombinant form of human B-type natriuretic peptide (hBNP),
a naturally occurring peptide produced by the heart. In clinical trials,
NATRECOR(R) 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(R) may cause hypotension. If hypotension occurs during
administration of NATRECOR(R), the dose should be reduced or discontinued, and
blood pressure should be monitored closely. At the recommended dose of
NATRECOR(R), 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(R) than IV nitroglycerin
(2.2 versus 0.7 hours, respectively). NATRECOR(R) 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(R) 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(R) 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(R) increased the risk of hypotension and elevated creatinine.
NATRECOR(R) 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.
 back to top
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.
|
