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Anemia drug fails to meet expectations in study
UT Southwestern Medical Center photo
A study led by Dr. Robert Toto of the UT Southwestern Medical Center suggests the drug darbepoetin alfa does nothing to reduce anemia sufferers' risk of ailments such as cardiovascular problems or death or the need for kidney dialysis. The study was paid for by pharmaceutical house Amgen, which markets darbepoetin alfa under the trade name Aranesp.
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Published: January 5, 2010
Updated:
An anti-anemia drug has failed to show an ability to reduce to risk of heart disease or death, as some had hoped. The drug, darbepoetin alfa, also fails to reduce the need for kidney dialysis, according to a newly published study.
The study by researchers at UT Southwestern Medical Center was funded by biotech firm Amgen, which markets darbepoetin alfa under the trade name Aranesp.
"We were disappointed that the drug didn't make a difference," said Dr. Robert Toto, professor of internal medicine at UT Southwestern and senior author of the study, which was published in The New England Journal of Medicine. "We set out doing this trial to prove whether treatment of anemia would help our patients."
The study of more than 4,000 anemia patients concluded that darbepoetin alfa was no more effective than an inactive placebo.
Even worse, the researchers found that study subjects who took the drug were nearly twice as likely to have a stroke as those who received the placebo. Among the study group 101 of the subjects taking darbepoetin alfa had a stroke, compared to 53 who took the placebo.
"If a clinician is treating a patient for fatigue and other symptoms of anemia and the symptoms do not improve, they should consider stopping the drug because it may expose the patient to increased risk of stroke," Toto said in response to this "surprise" finding.
Darbepoetin alfa is a synthetic form of erythropoietin, a hormone that regulates the creation of red blood cells. The U.S. Food and Drug Administration has approved the use of darbepoetin alfa as a treatment for chronic kidney disease in people with anemia.
In addition to UT Southwestern, the darbepoetin alfa study was conducted at centers elsewhere in the United States, Europe and South America.
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