DEERFIELD, Ill., March 9 /PRNewswire-FirstCall/ -- 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. . 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 http://www.baxter.com .
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 CorporationCONTACT: Media, Jerreau Beaudoin, +1-847-948-3425, or Deborah Spak,+1-847-948-2349, or Investors, Mary Kay Ladone, +1-847-948-3371, or ClareTrachtman, +1-847-948-3085, all of Baxter
Web site: http://www.baxter.com/
