Aricept Makers Says
11 Patients Die in Alzheimer’s Disease Drug Study – Other Studies
Compare Aricept, Razadyne and Exelon Treatments
March 16 2006
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
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
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
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,"
Birks’ review appears in the January issue of The Cochrane Library, a
publication of The Cochrane Collaboration.
By Dan Wilson
Books on the Mind
Keywords and Misspellings: Alzymers Alzhymers
arisept dementia dimentia dimensia vasculer