HIGH EPO DOSE MAY INCREASE RISK IN DIABETIC DIALYSIS PATIENTS

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HIGH EPO DOSE MAY INCREASE RISK IN DIABETIC DIALYSIS PATIENTS
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Posted in News, Epogen, Erythropoietin-Stimulating Agents (ESAs), Anemia, Clinical & Pharma, Bundle Payment, Government & Regulation

BETHESDA, Md.—Higher doses of erythropoietin-stimulating agents (ESAs) may increase the risk of mortality and cardiovascular outcomes in diabetic dialysis patients, according to a study published online June 22 in Kidney International.

Nearly half of all chronic kidney disease (CKD or predialysis) patients as well as dialysis patients have co-morbid diabetes. Those with diabetes generally receive higher epoetin (or ESA) doses, attain lower hematocrit levels, have a higher mortality rate, and experience more cardiovascular events, according to the researchers.

 A recent randomized trial (TREAT) was restricted to diabetic CKD predialysis patients and found no cardiovascular or renal benefits and an increased risk for stroke for those assigned to darbepoetin compared with placebo, according to the researchers. A study was conducted to see if diabetic dialysis patients also experienced adverse events using high ESA doses. 

Taking a deeper look into the topic, researchers from the Medical Technology and Practice Patterns Institute (MTPPI), Department of Veterans Affairs, and the Harvard School of Public Health conducted a study to evaluate this risk in diabetic patients receiving dialysis. Using the U.S. Renal Data System, they identified 35,593 elderly Medicare patients on hemodialysis, of whom 19,034 were diabetic.

They concluded that high ESA doses are associated with a greater risk of death and cardiovascular outcomes. In diabetic patients, the adjusted 9-month risk of death increased from 20 percent for a dose of 15,000 units/week to 33 percent for 45,000 units/week. The effect on non-diabetic patients was smaller (from 24 percent to 30 percent).

The researchers said the study results support a harmful effect of receiving high ESA doses among diabetic dialysis patients. At high ESA levels, diabetic hemodialysis patients could be at a higher risk for adverse outcomes when compared to their nondiabetic counterparts due to the increased presence of hypertension in this group, according to the researchers.

“Starting Jan. 1, 2011, Congress directed CMS to implement the ESRD Prospective Payment System (PPS) bundling, which includes ESA therapy, that will undoubtedly reduce ESA exposure among dialysis patients,” MTPPI wrote in a news release.  “Therefore, post bundling, it is expected that fewer adverse outcomes associated with high ESA doses will occur among dialysis patient who also suffer from diabetes. However, for renal failure patients outside of the bundle, namely predialysis CKD patients, ESA use and adverse consequences could increase.”

http://www.renalbusiness.com/news/2011/06/high-epo-dose-may-increase-risk-in-diabetic-dialysis-patients.aspx