"Hasten down the wireHome | About | Archives | Wiki | FeedbackAnemia or heart problems: take your pick
By Michael Fraase
Thursday, 16 November 2006 08:56PM CST
Almost all dialysis patients receive relatively high doses of epoetin (“epo”) as treatment for anemia, one of the complications of end-stage renal disease (permanent kidney failure). A New England Journal of Medicine study released today indicates that these high epo doses may raise the risk of heart problems and death. The study found that kidney failure patients who were not yet on dialysis who received enough epo to almost fully correct their anemia were 34 percent more likely to develop heart problems or die than those whose anemia was treated less aggressively. Dr. Ajay Singh, an associate professor at Harvard Medical School, and the study’s lead researcher, told the New York Times that the study’s results would apply to dialysis patients as well.
This study’s findings are nearly identical to those of a study earlier this year.
Epo sales are big business for pharmaceutical companies and for the dialysis centers that provide the injections. The two companies that make the drug sold more than US$9 billion worth last year and dialysis centers see higher profits with larger epo doses. According to Alex Berenson’s report in the New York Times, “In the first nine months of 2006, Amgen sold $4.9 billion of Aranesp and Epogen, accounting for almost half its revenue. Sales of the two drugs rose almost 15 percent compared with the period in 2005.”
The epo dosage levels in US patients have nearly tripled in the last decade while dosages in European patients has remained lower. Almost 25 percent of US dialysis patients die annually, compared to 15 percent of European patients.
A US Food and Drug Administration (FDA) spokeswoman told the New York Times that the agency would “release a more complete advisory today” with regard to epo dosages.
So, how much epo is too much? The FDA guidelines call for enough epo to reach a target hemoglobin level of 10-12 grams per deciliter of blood (healthy men have hemoglobin levels of at least 14 grams per deciliter). In the general population, treatment is believed to be necessary when hemoglobin levels fall below 10 grams per deciliter. National Kidney Foundation guidelines call for hemoglobin levels of 11-13 grams per deciliter but Amgen sponsored the development of those guidelines.
There doesn’t seem to be much difference between the two guidelines, but the Singh study used an average “low” dose of 11.3 grams and an average “high” dose of 12.6 grams and found a 34 percent greater incidence of death and heart attack in the “high” dosage group. What appears to be minor is in fact a very big deal.
According to the New York Times report, DaVita is especially aggressive with epo dosages: “A paper that will be presented Saturday at the American Society of Nephrology’s annual conference in San Diego found that 37 percent of Davita patients reported hemoglobin levels greater than 14 grams at least once in a nine-month period, an abstract of the paper posted online said.”
This is bad news for dialysis patients. Take smaller doses of epo and feel crappy most of the time or take higher doses and risk heart attack or death.
Permalink | (0) Trackbacks | (0) Comments"