Anemia Drug May Raise Stroke Risk in Kidney Patients

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Pfeffer believes that people with more severe kidney disease, such as those on dialysis, might still find Aranesp beneficial and the risk acceptable.

"People on dialysis generally feel even worse and generally have even more severe anemia, and this class of therapy has been very helpful to them," he said.

Because the drug was beneficial to these patients, doctors assumed it would help less severely anemic patients, Pfeffer said.

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"But this use of ESAs exceeded the data," he said. "Now we have the data, and we will revisit how the drug is used now."

Dr. Phillip Marsden, a professor of medicine at the University of Toronto and author of an accompanying journal editorial, said these findings mean that doctors and patients will have to discuss whether or not to start the medication.

"For most of these patients, the modest improvement in quality of life will not be enough to subject themselves to the increased risk of stroke and death," he said.

ESAs have been used for two decades, Marsden noted. "It is a bit shocking that it took us 20 years to address whether or not these drugs were safe -- and now we know more."

Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital, said this "landmark study" raises the fundamental question of whether epoetin or darbepoetin should routinely be used in treating anemia of chronic kidney disease.

"Earlier studies raised the specter of increased risk with ESA treatment. This study definitively confirms that there is meaningful risk with routine use of ESAs," said Singh, also an associate professor of medicine at Harvard Medical School.

"In my own practice, I will be cautious in using ESAs for most patients with chronic kidney disease, balancing risk with benefits and reserving treatment largely for patients who need frequent blood transfusions or who are candidates for a kidney transplant," he said.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.

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