Further Study is Warranted to Evaluate the Role of Chronic Diuretics in
Heart Failure
NEW ORLEANS, March 8 /PRNewswire/ -- Data presented today from the world's
largest heart failure registry known as ADHERE(R) (Acute Decompensated Heart
Failure National Registry) raised the question whether chronic diuretics, in
widespread use for several decades for treating heart failure patients with
insufficient renal function, might be harmful in these patients. These data
were presented at the American College of Cardiology Scientific Sessions 2004
in New Orleans.
"We were surprised to find increased mortality associated with chronic use
of diuretics in both heart failure patients who had renal insufficiency and
those with earlier stages of renal disease," said Maria Rosa Costanzo, M.D. of
Midwest Heart Specialists in Naperville, IL. "The ADHERE study is the first
study of this magnitude to raise the possibility that long-term use of
diuretics in heart failure patients with renal insufficiency may be
inappropriate therapy for these patients."
Renal insufficiency (RI) is a condition that commonly occurs in patients
suffering from heart failure. In patients with heart failure RI may progress
to the point of requiring hemodialysis. A failing heart that cannot pump
enough nutrient- and oxygen-rich blood through the body and kidneys, may
exacerbate or cause renal insufficiency. Common treatments for patients with
heart failure who suffer from renal insufficiency include IV vasoactive
agents, ACE inhibitors, beta-blockers and diuretics. Diuretics are agents used
to increase urine flow, causing the kidneys to excrete more than the usual
amount of sodium, potassium and water.
"The analysis of data from ADHERE calls for closer examination of whether
chronic use of diuretics in decompensated heart failure patients who
experience renal insufficiency is appropriate treatment, despite this
having been a standard of care for several decades in these patients," said
Dr. Costanzo. "There are a number of newer treatments available for patients
with decompensated heart failure, such as IV vasoactive agents, that might
merit investigation for their effects on outcomes in heart failure patients
with renal insufficiency."
The study, presented by Maria Rosa Costanzo, M.D., evaluated data from
ADHERE, a first-of-its-kind national registry that prospectively collects
observational data from across the United States in order to track and study
the medical management of patients hospitalized with acute heart failure. The
ADHERE National Registry is sponsored by Scios Inc. and overseen by an
independent scientific advisory committee of nationally recognized heart
failure experts.
Dr. Costanzo's presentation, titled "Impact of Renal Insufficiency and
Chronic Diuretic Therapy on Outcome and Resource Utilization in Patients With
Acute Decompensated Heart Failure" (ACC #1069-114), evaluated resource
utilization and outcomes from ADHERE Registry data on 46,599 patients
hospitalized with decompensated heart failure, also called acute decompensated
heart failure. Patients were divided into one of two groups based on their
blood level of creatinine (Cr), a measure of renal function. One group of
35,423 heart failure patients had Cr levels less than 2.0 mg/dl, or minimal to
no renal insufficiency. Another group of 10,317 heart failure patients had Cr
levels of at least 2.0 mg/dl, or more pronounced RI. These two groups were
then further evaluated based upon whether or not patients were treated
chronically with diuretics.
Seventy percent (24,775) of heart failure patients with minimal
to no renal insufficiency were treated chronically with diuretics, while
30% (10,648) were not. The percentage of patients with more pronounced renal
insufficiency who were treated chronically with diuretics was similar.
Seventy-two percent (7,380) of patients with more pronounced renal
insufficiency were treated with diuretics and 28% (2,937) of these patients
did not receive diuretics.
Mortality and hospital length of stay data were evaluated in patients who
received treatment chronically with diuretics and in those who did not receive
treatment with the drugs. What the study investigators found was that heart
failure patients who fared the best, with the lowest mortality and the
shortest hospital length of stay, were those who had minimal to no renal
insufficiency and who did not receive chronic treatment with diuretics. Heart
failure patients who fared the worst, with the highest mortality and the
longest hospital length of stay, were those with more pronounced renal
insufficiency who did receive chronic treatment with diuretics.
High creatinine levels and chronic treatment with diuretics were both
strong independent predictors of mortality. In the patients with low Cr
levels, mortality was higher in those receiving chronic diuretics (3.3% versus
2.7%; p<0.001). Also in the patients with high Cr levels, mortality was higher
in those receiving chronic diuretics (7.8% versus 5.5%; p<0.001). When the
data were adjusted for baseline levels of creatinine in the blood, treatment
with chronic diuretics was still associated with significantly increased
mortality in heart failure patients.
About ADHERE
The ADHERE Registry Core Module was launched in October 2001. It is a
multicenter, observational, open-label registry of the management of patients
treated in the hospital for acutely decompensated congestive heart failure
(CHF). The Registry is a large clinical database that utilizes information
collected from acute care hospitals across the United States. This
first-of-its-kind registry is designed to help the medical community better
understand acute CHF, improve its management and enhance quality of care. Data
regarding current management and treatment trends is collected from The
Registry and analyzed on a quarterly basis. These data and insights can be
used by individual hospitals to develop guidelines and protocols and increase
the use of evidence-based therapies to improve the standard of care among
heart failure patients, and potentially reduce costs.
To learn more about The ADHERE Registry, call 1-866-616-2993, or e-mail
adhereinfo@sciosinc.com, or visit http://www.adhereregistry.com.
About Heart Failure
More than 5 million Americans have congestive heart failure and nearly
1 million patients will be discharged from a hospital with the disease this
year, making the disease epidemic. In 2004, the estimated cost to the
healthcare system for treating congestive heart failure patients is expected
to reach $28.8 billion.
Congestive heart failure is characterized by a progressive loss in the
heart's ability to pump blood. Since a weak heart does not pump very well,
blood does not flow as well throughout the body. Because blood isn't flowing
as easily through the body, fluid can sometimes back up and "pool" in the
lungs or ankles. This is why heart failure is often called "congestive" heart
failure, or CHF.
When a heart failure patient's condition suddenly or rapidly deteriorates
to the point that hospitalization is required, the patient is described as
having experienced acute heart failure or acute decompensated heart failure.
The term decompensated is a medical term used to describe patients whose
condition has rapidly deteriorated.
Acute heart failure is a major public health problem. It is the leading
cause of hospitalization in persons over 65 years of age and accounts for
approximately one million hospital admissions each year in the United States.
The major expenditure for heart failure care is hospitalization, with an
estimated 12.7 billion dollars spent per year on the inpatient management of
AHF.
About Conventional Therapies for Heart Failure
Conventional therapies for heart failure are guideline-recommended
therapies that are used to treat most heart failure patients. Such therapies
include beta-blockers, ACE inhibitors, Angiotensin II receptor blockers,
spironolactone, vasoactive agents and diuretics. Conventional therapies for
acute heart failure include these therapies as well as inotropic agents and
vasoactive agents administered intravenously (IV), such as nitroglycerin or
the natriuretic peptides.
About Scios Inc.
Scios Inc., a member of the Johnson & Johnson Family of Companies, 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 for
markets with unmet medical needs.
SOURCE Scios, Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Karin Bauer Aranaz of WeissCom Partners,
Inc., +1-415-859-3414, for Scios, Inc.; or Chris L. Ernst of
Scios Inc., +1-415-710-9445
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