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Company reports 11 deaths in Aricept study

Mar 18, 2006 | Newsday

Eleven patients have died while taking the Alzheimer's drug Aricept in a clinical trial testing the drug as a treatment for vascular dementia, a company official said.

Judee Shuler, a spokeswoman for Eisai Co. of Japan, which jointly markets the drug in the United States with New York-based Pfizer, said the difference in mortality between those on the drug and those on a placebo was statistically significant.

But she noted that, even so, "This was an unexpectedly low mortality rate, given this patient population. The safety review results were reported to regulatory authorities on a global basis."

There were 11 deaths over a 24-week period reported in the Aricept (known generically as donepezil) group of 648 study participants, compared with none in the group of 326 people given a placebo.

In two previous trials, Shuler said, there was no statistical difference in the mortality rate of the two groups.

"Based on the results of our safety review, of our vascular dementia studies and our placebo-controlled Alzheimer's studies, we continue to believe that donepezil has a favorable benefit risk profile," Shuler said.

Dr. Marc L. Gordon, chief neurologist at The Zucker Hillside Hospital in Queens, said the drug is approved by the Food and Drug Administration to treat mild Alzheimer's symptoms and has proven to be "modestly effective."

"It is not a cure, not a miracle drug, but it clearly helps people," he said.

Vascular dementia is a common form of cognitive decline that results from narrowing and blockage of arteries that supply blood to the brain. There is evidence the drug helps with cognitive and memory problems associated with stroke.

Speaking of the overall results, Dr. Stephen Marks, professor of neurology at Westchester Medical Center, said, "These kinds of numbers don't require any concern."

The drug was approved in 1997 and is the most commonly prescribed drug used to treat Alzheimer's.

Most patients in the trial had a history of stroke or heart disease and were taking medicines to treat other aliments, Shuler said.

The FDA did not respond to numerous inquiries Friday.


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