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NEW DATA PUBLISHED IN LEADING NEPHROLOGY JOURNAL SUGGEST AT-HOME DIALYSIS AN EFFECTIVE OPTION FOR MORE PATIENTS WITH ADVANCED KIDNEY DISEASE
EAPOS (European APD Outcomes Study) and ECBT (Extraneal Clinical Benefits Trial) Data Demonstrate Broader Use of Home-Based Peritoneal Dialysis (PD)
SAN DIEGO, Calif, November 13, 2003 - Research findings from the European APD Outcomes Study (EAPOS), published in this month's Journal of the American Society of Nephrology (JASN) demonstrate the potential for greater numbers of end-stage renal disease (ESRD) patients to benefit from home-based peritoneal dialysis (PD). Additionally, the study suggests that automated peritoneal dialysis (APD) is an effective option for even the most difficult-to-treat or high-risk ESRD patients.
The results from another study, the Extraneal Clinical Benefits Trial (ECBT), published in the September issue of JASN also support the broader application of PD therapy. The study demonstrates the use of Baxter's Extraneal (icodextrin) PD solution in optimizing fluid balance (ultrafiltration), a major predictor of survival in ESRD patients. The publication of both studies coincides with the 2003 American Society of Nephrology annual meeting this week in San Diego, California.
"Taken together, the results of these two studies illustrate the advances made in PD therapy, making it a viable treatment option for greater numbers of kidney disease patients than previously thought," said Salim Mujais, M.D., vice president of Global Medical Affairs for Baxter's Renal business.
EAPOS Demonstrates Effectiveness of PD for Anuric 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. Results from the study showed that at two years, the patient survival rate for those enrolled in the study was 77 percent. Additionally, approximately 60 percent of anuric patients who began the trial remained on APD throughout the two-year study. These statistics are significant because it has been suggested previously that PD is most effective when patients still have some of their natural kidney function, which would exclude anuric patients .
"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 Edwina A. Brown, M.D., an EAPOS study investigator from the Imperial College School of Science, Technology and Medicine, Charing Cross Hospital, London, UK.
EAPOS was a two-year, prospective, multi-center study supported by Baxter and 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 APD and can also achieve adequate ultrafiltration, the effective management and removal 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 body.
Icodextrin Improves Fluid Balance For PD Patients
Ultrafiltration, or optimal fluid balance is a major predictor of survival in ESRD patients. Results from the Baxter-sponsored ECBT trial, conclude that PD patients studied achieved increased ultrafiltration during long-dwell dialysis exchange with icodextrin. Ultrafiltration gains were noted in these patients for up to six months. These patients also sustained a reduction in body weight. Overall study results demonstrate that a dialysis prescription switch to icodextrin for patients with challenging fluid management needs can result in improved ultrafiltration and reduced body weight, without compromising residual renal function. Study results are detailed in the September JASN article, "Icodextrin Improves the Fluid Status of Peritoneal Dialysis Patients: Results of a Double-Blind Randomized Controlled Trial."
The trial compared 7.5 percent icodextrin to 2.5 percent dextrose (2.27 percent glucose) in 50 ESRD patients (28 patients on icodextrin and 22 patients on dextrose) over a six-month period. The study was a prospective, multicenter, randomized, double-blind trial that compared icodextrin (7.5 percent) and dextrose (2.5 percent) for the long-dwell dialysis exchange of CAPD (continuous ambulatory peritoneal dialysis) and APD. Patients were screened at one-month, two-month and six-month intervals and primary outcome measures included 24-hour ultrafiltration, residual renal function, sodium loss, body weight measured with no PD fluid present, and total body water.
"Dwell" is the amount of time dialysis solution remains in the abdominal cavity during PD therapy, which is usually performed in the home. "Exchange" refers to the process of discarding used dialysis solution and instilling fresh dialysis solution into the abdominal cavity. Ultrafiltration is the removal of fluid from the bloodstream during dialysis.
About Peritoneal Dialysis (PD)
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. 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 ESRD (End-Stage Renal Disease)
ESRD is an advanced stage of chronic kidney disease that requires some form of renal replacement therapy. The incidence and prevalence of ESRD have doubled in the past 10 years and are expected to continue to grow five-to-six percent annually. Worldwide, approximately 1.5 million patients are being treated for ESRD. More than 300,000 Americans, or more than one in 1,000 people, are being treated for kidney disease. More information on ESRD and its treatments can be found on www.kidneydirections.com .
Important Information
EXTRANEAL is contraindicated in patients with a known allergy to cornstarch or icodextrin or in patients with glycogen storage disease. In clinical trials the most frequently reported adverse events occurring in =10% of patients, and more common in EXTRANEAL patients than in control patients, were peritonitis (26% vs 25%), upper respiratory infection (15% vs 13%), hypertension (13% vs 8%), and rash (10% vs 5%). These were also observed in control patients. The most common treatment-related adverse event for EXTRANEAL patients was skin rash (5.5% vs 1.7%). Since falsely elevated glucose levels have been observed with blood glucose monitoring devices and test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ)-based methods, GDH PQQ-based methods should not be used to measure glucose levels in patients administered EXTRANEAL. The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose results. Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of treatment. Individual prescribing information may differ.
About Baxter
Baxter's Renal business provides a complete and complementary 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.
Extraneal (icodextrin) is a registered trademark of Baxter International Inc. and its subsidiaries. Extraneal is currently approved for use in the United States, Europe and multiple countries in Asia. Complete Extraneal prescribing information can be found on www.kidneydirections.com or www.baxter.com.
This news release contains forward-looking statements that involve risks and uncertainties, including technological advances in the medical field, the effect of economic conditions, actions by regulatory authorities at any stage of the development and commercialization process, product demand and market acceptance, 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.
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