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A recent systematic review of all published “gold standard” clinical trials of the Alzheimer’s disease drugs donepezil (ARICEPT), rivastigmine (EXELON), and galantamine (REMINYL) concludes that the scientific basis for recommending the use of these drugs is “questionable.” The review was published in the August 5, 2005 issue of the British Medical Journal and the authors were from the University of Hamburg-Eppendorf in Germany.
This review adds additional evidence to support our...
A recent systematic review of all published “gold standard” clinical trials of the Alzheimer’s disease drugs donepezil (ARICEPT), rivastigmine (EXELON), and galantamine (REMINYL) concludes that the scientific basis for recommending the use of these drugs is “questionable.” The review was published in the August 5, 2005 issue of the British Medical Journal and the authors were from the University of Hamburg-Eppendorf in Germany.
This review adds additional evidence to support our long-standing listing of these drugs as DO NOT USE because of their questionable effectiveness. At this time there are no safe and effective treatments that substantially alter the progression of Alzheimer’s disease.
Donepezil, rivastigmine, and galantamine belong to the family of drugs known as cholinesterase inhibitors. These drugs inhibit the enzyme that breaks down acetylcholine, a brain transmitter, a deficiency of which has been thought to play a role in Alzheimer’s disease.
The authors of the review identified 22 published studies testing the use of the three drugs in the treatment of Alzheimer’s disease. The most common measure of effectiveness used in these trials was the Alzheimer’s disease assessment scale — cognitive subscale (ADAS-cog). Scores can range from zero (no impairment) to 70, which corresponds to severe impairment from Alzheimer’s disease.
A minimal benefit was reported for these drugs compared to a placebo in 12 of 14 studies that used the ADAS-cog scale. This benefit amounted, on average, to a change of 1.5 points to 3.9 points, compared to treatment with a placebo, on the 70-point scale. This is a very small benefit indeed.
The review concluded that:
Because of flawed methods and small clinical benefits, the scientific basis for recommendations of cholinesterase inhibitors for the treatment of Alzheimer’s disease is questionable.
The authors also found that “donepezil, rivastigmine, and galantamine caused a broad spectrum of adverse events — nausea, vomiting, diarrhoea, and weight loss were the most common.”
Our previous articles on donepezil can be found in the August 1997, September 1999, March 2004, and September 2004 issues of Worst Pills, Best Pills News. Rivastigmine was covered in January 2001 and March 2001 and galantamine in the March 2005 newsletter.
Donepezil, rivastigmine, and galantamine accounted for more than $861 million in retail sales in the United States in 2004. This astounding dollar amount is not evidence of either the effectiveness or safety of these drugs, but is rather a testament to the marketing skills of the drug industry, aimed at consumers and prescribers.
The very successful strategy to sell Alzheimer’s disease drugs is based on hope, fear, and guilt: hope that one of these drugs might “work,” fear that if one of these drugs is not started quickly all will be lost, and guilt if family members have not made the decision to “fight” the disease with these expensive, minimally effective drugs.
What You Can Do
Do not use donepezil, rivastigmine, or galantamine. At this time there are no safe and effective treatments that substantially alter the progression of Alzheimer’s disease.
