Aranesp drug doubles the risk that kidney patients will suffer a stroke

Amgen's Anemic Results
Robert Langreth, 10.30.09, 08:40 PM EDT
The company's best-selling Aranesp drug doubles the risk that kidney patients will suffer a stroke.

More bad news for Amgen and its beleaguered anemia drug franchise: A giant trial finds the company's Aranesp drug nearly doubles the risk of strokes in kidney disease patients.

Aranesp sales have already been plummeting amid various safety problems, including a drumbeat of data showing drugs like it may boost deaths or tumor progession in cancer patients, once a big market for anemia drugs.

The new lousy findings in kidney patients could provide yet another reason for wary doctors to further cut back on their usage of the drug, and similar compounds like Amgen's ( AMGN - news - people ) Epogen. "This will give physicians pause," says Brigham & Women's Hospital cardiologist Marc Pfeffer, who led the trial. "It will make them think twice and ask what is the reason I am doing this" before treating patients with Aranesp.

The results, he says, suggest that many patients with milder cases of anemia don't need to be treated until their anemia becomes severe. Exactly how big an impact the new trial will have on Aranesp sales is unclear, as the particular group of kidney patients studied do not routinely get Aranesp or Epogen today. The drugs, bioengineered versions of the natural human protein erythropoietin, are more commonly used in patients on kidney dialysis.

During the trial, 5% of patients on Aranesp had strokes versus just 2.6% of those treated with a placebo. The stroke risk "is pretty strong," admits Amgen research chief Roger Perlmutter. While the potential to cause strokes was previously known, "what is different is the magnitude of the risk. People will pay attention to this."

Amgen previously announced the main results of the 4,038-person trial, which found Aranesp did nothing to lower rates of death or heart attacks in patients with kidney disease and diabetes, contrary to hopes when the trial began. The full data are being presented at a big conference of kidney specialists Friday and published in the New England Journal of Medicine.

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