The drugs most commonly used to soothe agitation and aggression in people with Alzheimer's disease are no more effective than placebos for most patients and put them at risk of serious side effects, including confusion, sleepiness and Parkinson's disease-like symptoms, researchers are reporting.
The report, based on a large government comparison of the drugs' effectiveness, challenges current practice so sharply that it could quickly alter prescribing habits, some experts said. About 4.5 million Americans suffer from the progressive dementia of Alzheimer's disease, and most patients with the advanced disease exhibit agitation or delusions at some point.
The drugs tested in the study Zyprexa from Eli Lilly; Seroquel from AstraZeneca; and Risperdal from Janssen Pharmaceutical belong to a class of medications known as atypical antipsychotics. The drugs are used to treat schizophrenia and other psychoses, and are commonly prescribed for elderly patients in long-term care facilities.
About a third of the estimated 2.5 million Medicare beneficiaries in nursing homes in the United States have taken the medications, researchers found. And the use of atypical antipsychotics in the elderly accounts for an estimated $2 billion in the annual sales of the drugs, much of the cost paid by Medicare and Medicaid.
Spokesmen for Lilly, AstraZeneca and Johnson & Johnson, which owns Janssen, noted that the drugs are not approved by the Food and Drug Administration for use in Alzheimer's patients, and that the companies do not market them for that purpose. The results of the study simply reflected the need for more research into the treatment of behavioral problems in Alzheimer's patients.
Dr. Thomas R. Insel, director of the National Institute of Mental Health, which financed the research, said, "What this study shows is that these drugs are clearly not the answer; they may be helpful for a minority of patients but we need to come up with better medications."
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