Baxter Presents New Evidence Demonstrating REVACLEAR Dialyzer Associated with Lower Drug Use During Hemodialysis

As a leader in innovative dialysis membranes, Baxter International Inc. (NYSE: BAX) announced the results of a large, retrospective, observational cohort study demonstrating that the company’s high-flux REVACLEAR dialyzer was associated with lower use of erythropoiesis-stimulating agent (ESA), a drug commonly infused during hemodialysis sessions to help stimulate red blood cell production. Lower drug use potentially makes treatments more cost-effective and lessens the chance of drug-related side effects. The study was published online in the American Society for Artificial Internal Organs Journal.

When compared with the Optiflux® 160 or Optiflux® 180 dialyzer, REVACLEAR dialyzer use was associated with approximately 100 to 600 fewer units of ESA per hemodialysis session, and trended toward lower IV iron doses, while maintaining equivalent dialysis adequacy and hemoglobin concentrations.

The ability to lower ESA doses without impacting hemoglobin concentration has both clinical and cost implications. U.S. Food and Drug Administration has recommended more conservative ESA dosing in patients with chronic kidney disease, because of data showing increased risks of cardiovascular events with ESA use in this patient population.3

''Maintaining hemoglobin levels using the lowest doses of ESA as possible in this patient population is important in preventing many cardiovascular complications and maintaining adequate energy levels,'' said Maggie Gellens, M.D., medical director, Baxter and one of the authors of the study. ''This study suggests that clinicians may be able to reduce patient exposure to ESAs without sacrificing hemoglobin levels.''

Based on the study findings, Baxter estimates that reducing ESA use by an average dose of 275 units represents potential savings of $4.39 (using 2016 WAC) per hemodialysis session. That equates to approximately $660 in savings per patient annually, given that a patient usually receives three dialysis sessions per week.

''Reducing the cost of one hemodialysis session can be significant considering that more than 60 million hemodialysis sessions are delivered in the U.S. annually,'' said Suzanne Laplante, senior director, Global HEOR, Baxter and a study author.

The propensity matched, retrospective study, which was funded by Baxter, evaluated the comparative effectiveness of commonly used dialyzers in the United States with respect to measures of dialysis treatment, anemia management, inflammation, and dialyzer clotting. The study was conducted with a U.S. large dialysis organization, and analyzed 37,500 patient records for 12 months following initiation of hemodialysis using one of the three dialyzers included in the study. Eligible patients were propensity score-matched 1:1 on a range of baseline characteristics, including age, gender, race, body weight, dialysis access type, and co-morbidities such as diabetes, congestive heart failure and coronary artery disease, among others.

ABOUT REVACLEAR DIALYZERS

Dialyzers serve an important function during hemodialysis, as they act as a filter to remove toxins from the blood. REVACLEAR, a high-flux dialyzer, contains a three-layer polyarylethersulfone membrane, which has been designed to provide selective permeability and minimal resistance to diffusion.4-7 REVACLEAR dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

For prescription only. For safe and proper use of the devices mentioned herein, refer to the Instructions for Use.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Forward-Looking Statements

This release includes forward-looking statements concerning Baxter's REVACLEAR dialyzer, related performance data, including anticipated benefits associated with its use (including potential cost savings). 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: product quality, manufacturing or supply issues; patient safety issues; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the impact of competitive products, pricing and disruptive technologies; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter and REVACLEAR are trademarks of Baxter International Inc.

1. Calculated from prevalent dialysis cases in U.S. Renal Data Systems 2015 Annual Data Report. Assumes 150 dialysis sessions per patient per year. https://www.usrds.org/2015/view/v2_01.aspx

2. Baxter data on file. 2016 ESA Cost Calculation. Cost calculation based on WAC as of April 6, 2016.

3. FDA Safety Announcement. June 24, 2011. http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm

4. Ronco C, et al. Nephrol Dial Transplant 2003; 18(Suppl 7):vii10–vii20.

5. Ward RA & Ouseph R. Abstract presented at the 40th ASN congress. San Francisco (USA). 2007. [abstract SA-PO510].

6. Bhimani JP, et al. Nephrol Dial Transplant 2010; 25:3990–3995.

7. Data on file. May 2013. Nilsson LG, Beck W and Bosch J. REVACLEAR White Paper. (USMP/MG3/140052).

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