A couple of interesting SCIO releases today.
First a positive one from the company-sponsored site:
Wednesday March 6, 9:00 am Eastern Time
Press Release
SOURCE: Advocate Christ Medical Center
New Medication May Lower Costs, Reduce Mortality for Patients With Heart Failure, Study Indicates
OAK LAWN, Ill., March 6 /PRNewswire/ -- A new medication derived from a hormone naturally secreted by the heart may reduce the risk of death and lower health-care costs for patients who have been hospitalized for treatment of congestive heart failure, according to researchers at Advocate Christ Medical Center in Oak Lawn, Ill.
In a study published in the March 6 issue of the Journal of the American College of Cardiology, physicians reported that congestive heart failure patients receiving a new intravenous (IV) drug, nesiritide, required less treatment and experienced fewer complications than those undergoing traditional therapies that include use of the standard drug, dobutamine.
``Most importantly, we found that readmissions to the hospital were fewer for patients treated with nesiritide and that the six-month rate of mortality was lower for this group than for those treated with standard medications,'' said the study's lead author, Dr. Marc Silver, chairman of the Department of Medicine and director of the Heart Failure Institute at Christ Medical Center.
The clinical trial, conducted at 46 institutions throughout the country, involved more than 300 congestive heart failure patients, approximately two-thirds of whom received varying doses of nesiritide. The remainder underwent standard treatment with dobutamine.
During a three-week period following hospital discharge, the rate of readmission to the hospital for congestive heart failure or for any other reason was down as much as 60 percent for those receiving the new medication when compared to the group on standard therapy, the study demonstrated. Six-month mortality rate also was significantly lower -- 18 percent to 24 percent mortality for those on nesiritide versus 31 percent for the dobutamine-treated patients.
The first in a new class of drugs, nesiritide is a recombinant form of B-type natriuretic peptide (BNP), a hormone that is secreted by the heart when the heart begins to fail. In fact, Christ Medical Center was the first institution in Illinois to begin using a simple blood test that detects the level of BNP in a person's bloodstream as a quick, cost-effective way of diagnosing heart failure in patients -- even in those who have not yet developed symptoms.
The study authors noted that the favorable clinical results obtained with nesiritide may be due to the neurohormonal changes and the enhanced diuretic effect associated with the medication.
An estimated 5 million Americans suffer from congestive heart failure, with 550,000 new cases diagnosed annually. More than 1 million hospitalizations, with a cost to the health-care system of $15 billion, occur in the United States each year as a result of acute congestive heart failure. Another 2 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.
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.
The study was supported by a grant from Scios, Inc. (Nasdaq: SCIO - news), a biopharmaceutical company based in Sunnyvale, Calif., and the manufacturer of nesiritide.
Located at 4440 W. 95th St. in Oak Lawn, Christ Medical Center is a 662-bed institution that is part of the Advocate Health Care system. The medical center is the Chicago area's largest and most comprehensive provider of heart care and is nationally recognized for its use of innovative technologies and advanced procedures in the treatment of heart disease. Cancer care, pediatrics, care of high-risk mothers and infants, women's health services and general surgery are other specialties for which Christ Medical Center is noted.
SOURCE: Advocate Christ Medical Center
Next a critical (but not inaccurate) release from Dow Jones - I smell a short's hand (Avalon?) here:
Scios Says Study Backs Heart Drug, but Includes Important
Limitations
- Mar 6, 2002 09:15 AM (Dow Jones Business News)
- finance.lycos.com
===========================================================================
SUNNYVALE, Calif. -- Scios Inc. says a new study suggests that heart patients
treated with its newly approved drug Natrecor may be more likely to live longer
and less likely to require additional hospital admissions than those treated
with dobutamine, a standard drug now used for congestive heart failure.
But the study, which Scios (SCIO) funded, also notes several important
limitations to that conclusion. For instance, the researchers -- a group led by
Marc Silver, director of the Heart Failure Institute at Advocate Christ Medical
Center in Oak Lawn, Ill. -- pointed out that the patients treated with
dobutamine might simply have been sicker than those treated with Natrecor.
In addition, the researchers noted that the design of the study made it
impossible to tell whether the differences in patient outcomes were due to the
beneficial effects of Natrecor or detrimental effects of dobutamine. Patients in
this study also received doses of Natrecor one-and-a-half to three times greater
than is currently recommended.
The researchers studied heart patients treated with Natrecor, known
generically as nesiritide, versus others who received "standard-care" drugs such
as dobutamine, nitroglycerin, milrinone or nitroprusside. The research paper in
question, which was published Wednesday in the Journal of the American College
of Cardiology, only compares two groups of patients receiving different doses of
Natrecor to those receiving dobutamine.
The study doesn't explain the decision to omit analysis of patients treated
with drugs other than Natrecor or dobutamine.
According to the study, Natrecor treatment didn't appear to reduce the overall
length of hospital stays, but patients receiving the drug were 69% less likely
to require readmission for congestive heart failure within 21 days compared with
those receiving dobutamine. In addition, patients receiving the lower dose of
Natrecor were 42% less likely to die within six months than who received
dobutamine.
Confirming those results, however, will require a larger study that is fully
randomized and "blinded" so that neither patients nor doctors know which drug is
being used, the researchers wrote.
Write to David P. Hamilton at david.hamilton@wsj.com
Copyright (c) 2002 Dow Jones & Company, Inc.
All Rights Reserved.
Here's the actual abstract:
Effect of nesiritide versus dobutamine on short-term outcomes in the treatment of patients with acutely decompensated heart failure *
Marc A. Silver MD ? * , Darlene P. Horton MD † , Jalal K. Ghali MD and Uri Elkayam MD §
Received: 8/10/2001. Revised: 11/21/2001. Accepted: 12/11/2001.
-----------------------------------------------------
Abstract
Objectives
This study was designed to determine whether nesiritide, administered for acute decompensated congestive heart failure (CHF), affects healthcare costs by hospital length of stay (LOS), readmissions and short-term mortality, compared to dobutamine.
Background
Dobutamine is a commonly used inotropic treatment for CHF. Although dobutamine may have favorable hemodynamic and symptomatic effects, its use may be associated with side effects such as tachycardia, cardiac arrhythmias and myocardial ischemia. Nesiritide (B-type natriuretic peptide) is a new intravenous (IV) drug that produces hemodynamic and symptomatic improvement through balanced vasodilatory effects, neurohormonal suppression and enhanced natriuresis and diuresis.
Methods
From an open-label randomized study of nesiritide versus standard care (SC) in patients with CHF requiring hospitalization, we compared short-term outcome data from patients given nesiritide (0.015 or 0.03 ?g/kg per min) with a subgroup of SC patients given dobutamine. A total of 261 patients are included in this analysis.
Results
Compared to dobutamine, both nesiritide doses were administered for a shorter total duration (p < 0.001), and the total duration of all IV vasoactive therapy (including study drug) was also shorter (p ? 0.012). Although there was no difference in LOS, there was a trend toward decreased readmissions in the two nesiritide groups (8% and 11%, respectively, vs. 20% in the dobutamine group). Six-month mortality was lower in the nesiritide groups.
Conclusions
Treatment of decompensated CHF with nesiritide may lead to lower healthcare costs and reduced mortality compared to treatment with dobutamine.
Bottom line though is that this result will certainly help in marketing the drug. Dobutamine is a pretty standard treatment for CHF and so even if the reason for the results was that dobutamine has long-term bad effects, that will still move people towards using nesiritide. I believe it is strongly suspected that repetitive use of dobutamine (or other inotropic drugs) increases long-term death rates among CHF patients.
Peter |
