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11 Die in Alzheimer's Drug Trial

Posted on: Monday, 20 March 2006, 09:00 CST

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. The difference in mortality between those on the drug and those on a placebo was statistically significant, said Judee Shuler, a spokeswoman for Eisai Co. of Japan, which jointly markets the drug in the United States with Pfizer. But she noted that, even so, "This was an unexpectedly low mortality rate, given this patient population." 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 Zucker Hillside Hospital in New York, said the drug is approved by the Food and Drug Administration to treat mild Alzheimer's symptoms and has proven "modestly effective." The FDA did not respond to numerous inquiries Friday.


Source: Cincinnati Post

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