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NEW
DATA SUGGEST AT-HOME DIALYSIS THERAPY AN EFFECTIVE OPTION FOR MORE PATIENTS
WITH ADVANCED KIDNEY DISEASE
Study Supports
Peritoneal Dialysis for Anuric Patients Who No Longer Have Kidney Function
SEATTLE, Wash., March
4, 2003 -- Research findings from the European APD (automated peritoneal
dialysis) Outcomes Study (EAPOS), suggest that APD, a home-based dialysis
treatment for people with end-stage renal disease (ESRD), is a suitable
option for even the most difficult-to-treat or high-risk patients. Specifically,
EAPOS examined the feasibility of long-term peritoneal dialysis (PD) therapy
for kidney disease patients with anuria, a condition in which the kidneys
are unable to excrete urine on their own. Results from the study showed
that at two years, the patient survival rate for those enrolled in the
study was 79 percent. Additionally, up to 60 percent of anuric patients
who began the trial remained on APD throughout the two-year study, which
is significant because PD therapy is not generally considered an option
for anuric patients. Data from the study, supported by Baxter Healthcare
Corporation, were presented this week at the Annual Dialysis Conference
in Seattle, Washington.
PD has not been widely used as a treatment option for anuric patients
because it is commonly believed among health-care professionals that PD
is most effective when patients still have some of their natural kidney
function.
"This study suggests that patients have effective therapy options,
including PD, even when their kidneys are completely unable to function
naturally. It challenges the current clinical belief that anuric patients
cannot adequately complete or be successfully maintained on PD therapy,"
said Simon Davies, NSRI, Stoke-on-Trent, Staffordshire UK, EAPOS study
investigator.
In PD, extra fluids and waste are removed from the blood inside the body,
using the body's own peritoneal membrane, or abdominal lining, as a natural
filter. This membrane lines the area that holds the stomach, spleen, liver
and intestines. In this form of dialysis, blood never leaves the body.
Dialysis fluid enters the peritoneal cavity through a flexible catheter
surgically inserted in the abdomen. Extra fluid and waste travel across
the peritoneal membrane into the dialysis fluid, which is then drained
from the abdomen through the catheter after a pre-determined dwell period.
APD is one type of PD that is performed at home with the help of a cycler,
or machine that performs dialysis automatically, usually while a patient
sleeps at night.
About EAPOS
EAPOS was a two-year, prospective, multi-center study designed to determine
the feasibility and clinical outcomes of APD in patients with anuria.
A total of 177 patients from 26 centers in 13 European countries were
enrolled in the EAPOS study, with a median age of 54 (range 21-91 years).
The data indicate that patients with anuria can be successfully treated
on PD and may also achieve adequate ultrafiltration, the effective removal
and management of fluid from the blood stream during dialysis. Ultrafiltration
is a primary goal of dialysis, since patients' kidneys have limited, if
any, residual ability to eliminate excess fluid from the bloodstream on
their own. Like findings from an earlier study called ADEMEX
(Adequacy of Peritoneal Dialysis in Mexico), EAPOS data confirm
that PD is a viable treatment option for a broader range of ESRD patients
than were typically considered candidates for therapy. ADEMEX and EAPOS
data were reviewed during several sessions at the Annual Dialysis Conference.
"We believe these results, coupled with previous research findings,
will help to increase options for physicians and patients when determining
how to treat this challenging group of patients," said Salim Mujais,
M.D., vice president of Global Medical Affairs for Baxter's Renal business.
About ESRD
ESRD is an advanced stage of chronic kidney disease. The incidence and
prevalence of ESRD have doubled in the past 10 years and are expected
to continue to rise steadily in the future. Worldwide, approximately 1.5
million patients are being treated for ESRD. In the United States, more
than 300,000 people -- or just over one in 1,000 -- are being treated
for ESRD.
About Baxter
Baxter's Renal business provides a complete and complimentary portfolio
of dialysis-related products used in the treatment of patients with kidney
disease, including dialysis systems and solutions, pharmaceuticals and
biotechnology products.
Baxter Healthcare Corporation is the principal domestic operating subsidiary
of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through
its subsidiaries, assists health-care 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.
This news release
contains forward-looking statements that involve risks and uncertainties,
including technological advances in the medical field, product demand
and market acceptance, the effect of economic conditions, actions of regulatory
bodies, the impact of competitive products and pricing, and other risks
detailed in the company's filings with the Securities and Exchange Commission.
These forward-looking statements are based on estimates and assumptions
made by management of the company and are believed to be reasonable, though
are inherently uncertain and difficult to predict. Actual results or experience
could differ materially from the forward-looking statements.
FOR ADDITIONAL
INFORMATION:
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Media Contacts:
Ilke Arici, Baxter, 847-948-3272
Mary Thomas, Baxter, 847-948-3506
Stephanie Kenney, Manning Selvage & Lee, 212-213-746
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