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To: Miljenko Zuanic who wrote (145)10/16/2000 9:29:21 PM
From: Miljenko Zuanic  Respond to of 362
 
Disruptive Behavior in Alzheimer's Disease Reduced in Short Term by Olanzapine
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WESTPORT, CT (Reuters Health) Oct 15 - Low-dose olanzapine appears to reduce the severity and frequency of behavioral and psychotic symptoms in elderly patients with Alzheimer's disease, according to a 6-week study conducted at 28 sites around the US.

Dr. Alan Breier, of Eli Lilly and Company in Indianapolis, and colleagues describe this study in the October issue of the Archives of General Psychiatry as "the first controlled study of an antipsychotic in an elderly demented population using a dose (15 mg/day) that is effective and tolerated in other psychotic disorders."

A total of 206 nursing-home patients, ages 61 to 97 years, were randomized to receive placebo or a fixed dose of 5, 10, or 15 mg/day of olanzapine.

At the 5- and 10-mg doses, patients improved approximately 50% on the sum of the Agitation/Aggression, Hallucinations, and Delusions items of the Neuropsychiatric Inventory-Nursing Home version (NPI-NH). Those on the 15-mg dose did not differ significantly from patients taking placebo.

The 5-mg/day dose resulted in significantly greater improvement than placebo on the Brief Psychiatric Rating Scale, as well as a significant reduction in caregiver distress according to Occupational Disruptiveness scores on the NPI-NH.

The only adverse events associated with olanzapine were somnolence, present in 25.0% to 35.8%, and abnormal gait. Gait disturbance, which included stooped posture, unsteady gait, leaning, and ambulation dysfunction, was present in 17.0% to 19.6%.

"We were very pleased and impressed with the safety profile, because this is a frail population," Dr. Breier told Reuters Health. "We saw no evidence of cognitive deterioration, suggesting that olanzapine is not having any negative impact on the Alzheimer's disease. Plus there was no evidence of anticholinergic side effects."

Currently, no antipsychotic agent is approved for treatment of behavior disturbances or psychosis in Alzheimer's disease, Dr. Breier noted. He added that he and his team have been working with the Food and Drug Administration to obtain a formal FDA indication for olanzapine in the treatment of psychosis of Alzheimer's disease.

"A drug as safe as olanzapine and able to control the psychosis, the agitation, and the hostility, is a very significant advancement for the field and for patients with this very severe disorder," Dr. Breier concluded.

Arch Gen Psychiatry 2000;57:968-976.