Dept. of Health & Human Services National Institute of Diabetes and
National Institutes of Health Digestive and Kidney Diseases
JOURNAL EMBARGO Contact: Mary Harris
Wednesday, December 18, 2002 Jane DeMouy
5 p.m. Eastern (301) 496-3583
Hemodialysis Study Results Published
Confirms Current Recommended Practice
The most comprehensive, randomized clinical trial of hemodialysis therapy to-date has confirmed the adequacy of current dosage guidelines. The researchers also found that using high-flux filters to remove larger waste molecules from the blood does not help patients live longer. Results appear in the Dec. 19 New England Journal of Medicine.
Patients in the Hemodialysis (HEMO) Study who received a dialysis dose higher than that recommended by National Kidney Foundation guidelines or who used high-flux filters neither lived substantially longer nor stayed out of the hospital more than those who received the currently recommended standard dose or used low-flux filters. The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.
"This will be welcome news to the hundreds of thousands of people who are on dialysis in the United States, since our findings support the Foundation’s current practice guidelines," said Garabed Eknoyan, M.D., study chair and professor of medicine at Baylor College of Medicine in Houston. "It is reassuring that the dose now recommended is adequate."
The HEMO Study evaluated the prevailing theory that a higher dose of dialysis or high-flux filters improve survival and reduce hospitalizations. Doctors at 15 medical centers recruited more than 1,800 hemodialysis patients and randomly assigned them to high or standard dialysis doses and high- or low-flux filters. Duration of survival was the major outcome studied, but hospitalizations, nutritional status and quality of life were also examined.
While survival and hospitalizations were not substantially different among study groups, there were intriguing, though not definitive, findings for certain patients. The high dose appeared to reduce the risk of death and hospitalization among women, regardless of race and body size, and high-flux filters appeared to reduce the risk of death among patients who had been on hemodialysis more than 3½ years when they joined the study.
"We are getting as much as we can expect out of 3 or 4 hours of dialysis given three times each week. To improve survival and reduce hospitalizations, we are probably going to need radical changes, such as significantly increasing the time on dialysis at each session or by increasing the frequency (number of days) of dialysis, both of which would need to be evaluated," said Eknoyan.
Kidney failure is a growing problem that can be prevented or slowed, but only a fraction of people who are at high risk are screened or managed appropriately. Patients, insurers and the U.S. Government’s Medicare program paid nearly $20 billion to treat 379,000 people for kidney failure in 2000. Most are on dialysis (275,000) and most dialysis patients are on hemodialysis (246,000). Nearly 6 percent of all Medicare expenditures for 2000 were for kidney failure. Diabetes and hypertension are leading causes. However, one study found that only 30 percent of diabetics were on a kidney-protecting ACE inhibitor when discharged from the hospital, and another showed that 70 percent of people being treated for high blood pressure are not reaching recommended levels.
Attempting to stem the rising tide of people with kidney failure, NIDDK’s National Kidney Disease Education Program (http://www.nkdep.nih.gov) will soon launch grass-roots pilot projects in Atlanta, Cleveland, Baltimore and Jackson, Mississippi, aimed at reducing kidney failure by increasing awareness about early diagnosis and aggressive management of kidney disease.
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Baxter Healthcare, Fresenius Medical Care, R&D Laboratories and Ross Laboratories donated products for the HEMO Study.
Learn about hemodialysis at http://www.niddk.nih.gov/health/kidney/pubs/kidney-failure/treatment-hemodialysis/treatment-hemodialysis.htm#equip.