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Aricept Makers Says 11 Patients Die in Alzheimer’s Disease Drug Study – Other Studies Compare Aricept, Razadyne and Exelon Treatments

March 16 2006

Aricept Makers Says 11 Patients Die in Alzheimer’s Disease Drug Study – Other Studies Compare Aricept, Razadyne and Exelon Treatments


Aricept is a drug used to treat Alzheimer’s disease in people with mild to moderate forms of the disease.  In a new clinical trial, 11 patients out of 648 died while taking the drug while none died taking the placebo.  Aricept was given once daily for 24 weeks.  The placebo was given to 326 patients. 

The Japanese maker of the drug, Eisai Co Ltd, reported the results to regulatory authorities and investigators.  The drug has been advertised on Television and has not been approved for vascular dementia in the United States, Japan or Europe, but is approved for the condition in a half dozen smaller markets.

The trial was conducted in nine countries and involved patients with vascular dementia only. None of the participants were diagnosed with Alzheimer’s disease. Most patients had a history of stroke or heart disease, and were therefore also taking medicines to treat these cardiovascular problems.


There are other options available for the treatment of Alzheimer’s disease, and a recent study compiled data from 13 high quality studies involving 7,298 patients taking Aricept, Razadyne or Exelon.  According to a review, by author Jacqueline Birks of the University of Oxford, the drugs can lead to small improvements in mental functioning and the ability to carry out everyday activities. 

There were 2,228 patients in the Aricept studies, 2,267 in the Razadyne studies and 2,803 in the Exelon studies.  All compared the drugs against the placebo.  According to Birks, in one measure of how well the drugs worked, patients across the studies improved by an average of less than three points on a 70-point scale that tracks mental functioning. "There is nothing to suggest the effects are less for patients with severe dementia, although there is very little evidence for other than mild to moderate dementia," Birks said.


Birks research showed fewer side effects for Aricept than the other two drugs.  She suggests that this may have to do with the way Aricept and the other two drugs are prescribed. The Aricept participants had a initial period where the drug was gradually introduced over a course of three months.  Razadyne and Exelon had a “ramp-up” period where patients take increasingly higher doses to get to a therapeutic level of treatment.

The side effects caused 29 percent of the patients taking the drugs to leave the studies, compared with 18 percent dropout among the patients taking a placebo.  The most common side effects were nausea, vomiting and diarrhea.


Birks then looked specifically at Aricept.  She noticed that a 5 milligram a day dose of the drug was only slightly less effective than a 10 milligram a day dose, with fewer side effects. Other recent reviews have concluded that Razadyne can improve or maintain mental functioning at a 16 milligram a day dose.

The three drugs are sometimes refereed to as called cholinesterase inhibitors.  They work by boosting chemical signaling in a group of brain neurons that are typically destroyed during the course of Alzheimer's disease.  According to Birks, there is no current way to determine whether the drugs will work on a particular Alzheimer's patient, but some researchers recommend starting the treatment as soon as possible after a diagnosis.

Dr. George Grossberg M.D. said "the earlier one starts the better" for slowing the progression of the disease.  Grossberg is a specialist in Alzheimer's treatment at the Saint Louis University School of Medicine. "In fact, patients who come to drugs later, even as little as six months later, never catch up with those who were on drug from the outset," Grossberg added.

Birks’ review appears in the January issue of The Cochrane Library, a publication of The Cochrane Collaboration.

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Copyright 2005 Best Syndication                                            Last Updated Saturday, July 10, 2010 09:50 PM