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A large study being published in a major medical journal says certain kidney disease patients who get the drug Aranesp to treat anemia-related fatigue may be at greater risk of having a stroke.
Researchers report in “The New England Journal of Medicine” that nearly twice as many patients who got Amgen’s Aranesp suffered a stroke versus those who were on the placebo. They also saw a higher death rate among study participants on Aranesp and who had a history of cancer.
Brigham and Women’s Hospital’s Dr. Marc Pfeffer, who led the clinical trial, says he and his colleagues don’t yet know why the stroke risk was so much higher, but in the meantime he believes use of Aranesp on this group of patients will decline.
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The study, which Amgen paid for, was done on more than 4,000 people who have type 2 diabetes, chronic kidney disease and anemia, but who were not on dialysis.
Amgen says it has already shared the data with the Food and Drug Administration and that it expects the results to eventually be turned into a warning on the drug’s label. Aranesp is designed to boost red blood cells, give people more energy and cut the need for transfusions. Other recent studies showed the drug may also cause tumor growth, resulting in new FDA warnings.
In a press release, Amgen’s head of research and development, Dr. Roger Perlmutter, is quoted as saying the risks of Aranesp will outweigh the benefit in this particular patient population.
Coincidentally, the study results are being released on the same day that New York Attorney General Andrew Cuomo announced he is leading a multi-state lawsuit against Amgen over alleged kickbacks to doctors who prescribe Aranesp.
The company says the allegations are without merit. In a research note to clients, JPMorgan biotech analyst Geoffrey Meacham wrote, “We are skeptical that the suit will cause any harm to Amgen (apart from PR.)”
On a day of broad stock market weakness, Amgen shares [AMGN
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] closed 1.23 percent lower Friday, above their intra-day low.
Dr. Pfeffer says he has received consulting fees from Amgen and many other drug and device makers. Amgen also gave him a grant to carry out the study.
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