Baxter Initiates Multi-Center Phase II Clinical Trial To Manage Fluid Overload In Congestive Heart Failure Patients

Baxter Healthcare
Corporation today announced the launch of a unique Phase II clinical trial
to determine if adding peritoneal ultrafiltration treatments using its
proprietary icodextrin solution to the current standard Congestive Heart
Failure (CHF) therapy regimen will improve clinical outcomes and reduce the
amount of time patients spend in the hospital.


CHF is a serious heart condition in which blood flow slows and starts
to back up, causing congestion in the tissues and abnormal fluid retention
that usually results in swelling (edema). One of the dramatic symptoms is
tiredness and shortness of breath, which is caused by the accumulation of
fluid in the lungs. In the trial, researchers will use peritoneal
ultrafiltration to remove excess salt and water in CHF patients and reduce
their edema.



"Peritoneal ultrafiltration could be the next frontier in helping to
manage treatment-resistant CHF -- one of the largest unmet needs in
medicine today," said Sarah S. Prichard, M.D., vice president of global
medical/clinical affairs and research for Baxter's Renal business. "This
may prove to be an innovative new way to improve fluid management in
patients in advanced stages of the disease. We believe it could not only
dramatically improve their quality of life, but also do it in a way that is
less invasive than current alternative therapies."



The trial, which is called "Peritoneal Ultrafiltration in Treatment-
Resistant Congestive Heart Failure," is a two-year prospective, randomized,
open-labeled controlled evaluation that will enroll 104 patients with
treatment-resistant severe heart failure at 16 sites in the United States,
Canada, Belgium and Australia.



At each site, patients will be randomly selected to receive either the
current standard CHF therapy or the standard therapy plus peritoneal
ultrafiltration using Baxter's proprietary icodextrin solution. In this
process, the solution is infused through a catheter into the abdominal
cavity, which is lined by the peritoneal membrane. This membrane serves as
a natural filter, across which the solution draws out toxins and fluid. The
used solution is then drained from the body. The treatment period will be
six to 24 months with the primary outcome measure being impact on
hospitalization rate. Also being evaluated is the effect on quality of life
and medication use.



Stuart M. Sprague, DO, Clinical Investigator and Professor of Medicine
in Nephrology, said, "Evanston Northwestern Healthcare is excited to
participate in this trial, especially since the pilot study we were
involved with showed the potential for decreasing hospitalizations and
improving quality of life. Studies have shown that ultrafiltration can more
effectively remove fluid than medication. This trial is a major milestone
in treating fluid overload in refractory CHF, and if successful, would be a
major advancement in this area."
















Heart failure affects approximately 5 million patients in the U.S., and
more than 550,000 new patients are diagnosed each year. Current treatments
for those with CHF depend on the severity of the condition, and range from
getting more rest, appropriate exercise and improving diet to using a
variety of drugs, including diuretics to help the body eliminate excess
salt and water -- an important aspect of treatment in that they improve the
congestive symptomatology, which typifies the more advanced stages of CHF.



The impact CHF has on the healthcare system is staggering. In the U.
S., the annual cost of inpatient care for CHF patients is estimated at $23
billion. It is the primary reason for 12 to 15 million office visits and
6.5 million hospital days each year. Heart failure is Medicare's most
common diagnosis-related group, and Medicare spends more dollars on its
diagnosis and treatment than any other group.



"Approximately 1 million U.S. hospital admissions per year are
attributable to a primary diagnosis of acutely decompensated heart failure
-- and 90 percent are due to fluid overload," notes Prichard. "Ultimately
our goal in this trial is to have an impact both clinically and
economically. There is a very real opportunity to significantly reduce the
costs of CHF care, emergency visits, admissions and length of stay."



About Baxter



Baxter Healthcare Corporation is the principal U.S. operating
subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International
Inc., through its subsidiaries, assists healthcare professionals and their
patients with treatment of complex medical conditions, including cancer,
hemophilia, immune disorders, kidney disease and trauma. The company
applies its expertise in medical devices, pharmaceuticals and biotechnology
to make a meaningful difference in patients' lives. For more information
about Baxter, please visit baxter.




This release includes forward-looking statements concerning the
development of peritoneal ultrafiltration for the treatment of CHF. The
statements are based on assumptions about many important factors, including
the following, which could cause actual results to differ materially from
those in the forward-looking statements: satisfaction of regulatory and
other requirements for timely enrollment and commencement of clinical
trials; additional clinical results demonstrating the safety and efficacy
of the product; market acceptance of such products; and other risks
identified in the company's most recent filing on Form 10-K and other SEC
filings, all of which are available on the company's web site. The company
does not undertake to update its forward-looking statements.


Baxter Healthcare Corporation

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