High-Dose Anemia Drug May Have Risks
Heart and Stroke Deaths Up for Kidney Patients Getting High-Doses of Epoetin
Nov. 16, 2006 -- Kidney patients get high doses of an anemia drug have a
higher risk of heart disease, stroke, and death, new clinical studies show.
The drug is epoetin alfa, a man-made form of a red-blood-cell-boosting
protein normally made in the kidneys. The drug is sold by Amgen as Epogen and
by Johnson & Johnson as Procrit. Amgen also makes a similar drug,
darbepoetin alfa, sold as Aranesp. Another similar drug, epoetin beta, is sold
in Europe as NeoRecormon by Roche.
Amgen, Johnson & Johnson, and Roche are WebMD sponsors.
People with chronic kidney disease often suffer
anemia. Anemia has been linked to increased risk for heart disease
complications and related death in people with chronic kidney disease.
Epoetin successfully treats anemia. High doses of the drug can raise red
blood cell levels back to normal.
That was supposed to be a good thing. But two major clinical trials now show
that it is not.
A 16-month, 1,432-patient clinical trial shows that kidney patients whose
red blood cell count is normalized with epoetin alfa have a 34% higher risk of
failure, heart attack, and stroke than
patients who take lower doses of the drug.
And a three-year study of epoetin beta shows that when it is used to
normalize red blood cell counts in kidney patients, it does not reduce their
risk of heart disease or stroke compared with patients who take lower doses of
Both studies appear in the Nov. 16 issue of The New England Journal of
It is not yet clear what the results mean. It could be that the real problem
is whatever causes anemia in kidney patients -- not the anemia itself. Or it
could be that correcting red blood cell levels comes at the cost of
complications that counterbalance the benefit.
Either way, the trials seem likely to put an end to routine, high-dose
epoetin treatment in kidney patients, note Giuseppe Remuzzi, MD, and Julie R.
Ingelfinger, MD, in an editorial accompanying the studies.
"It seems wisest to refrain from complete correction of anemia in
persons with chronic kidney disease," Remuzzi and Ingelfinger conclude.