Baxter (BAX) Announces Presentation of Strong Data on REVACLEAR in Lower Drug Use During Hemodialysis

July 27, 2016 8:31 AM EDT

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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.



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