(PSYCHIATRIC TIMES) - LOS ANGELES, Oct. 11 -- Two of three atypical antipsychotic drugs were no better than placebo at quieting aggression, psychosis, and agitation in patients with Alzheimer's disease, found a multicenter trial.
Overall, the adverse effects of all three outweighed the benefits, Lon S. Schneider, M.D., of the University of Southern California, and colleagues, reported in the Oct. 12 issue of the New England Journal of Medicine. In the study of more than 400 such Alzheimer's patients, a majority were taken off the drugs.
In addition, up to a quarter of the patients taking the drugs dropped out because of adverse effects, compared with only 5% of those given placebo.
The study suggests that the atypical antipsychotics Zyprexa (olanzapine), Risperdal (risperidone), and Seroquel (quetiapine) do not provide significant clinical benefits in patients with Alzheimer's, the investigators wrote.
"Antipsychotic medications have been used extensively for Alzheimer's patients without enough solid evidence of whether they are effective," said Thomas R. Insel, M.D., director of the National Institute of Mental Health, which funded the study.
"The study has vital public health implications because it provides physicians and patients with information to more accurately weigh the medications' benefits against their drawbacks, with the needs and unique reactions of their individual patients," Dr. Insel said.
Atypical antipsychotic agents have revolutionized the treatment of schizophrenia and other conditions with psychotic components, but these agents are not approved for use in older patients with dementia.
In fact, the drugs carry an FDA-mandated black-box warning stating that "elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo," noted Jason Karlawish, M.D., of the Institute on Aging at the University of Pennsylvania, in an accompanying editorial.
To determine whether the drugs could play a role in controlling the symptoms of outpatient Alzheimer's patients, Dr. Schneider and co-investigators in the Clinical Antipsychotic Trials of Intervention Effectiveness -Alzheimer's Disease (CATIE-AD) study conducted a 42-site, double-blind, placebo-controlled trial.
The 421 participants had who exhibited delusions, hallucinations, aggression, or agitation that developed after the onset of dementia and was judged to be severe enough to disrupt their function and warrant treatment with antipsychotic agents.
The patients were randomly assigned to Zyprexa at a mean dose of 5.5 mg per day, Seroquel at a mean dose of 56.5 mg per day, Risperdal at a mean dose of 1.0 mg per day, or placebo. The drug doses were adjusted as needed, and patients were followed for up to 36 weeks.
The primary study outcomes were the time from the start of treatment to discontinuation for any reason, and the number of patients with at least a minimal improvement on the Clinical Global Impression of Change scale at 12 weeks.
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