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Multi-Trial Analysis Shows Risperidone Effective in Treating Dementia-Related Agitation, Aggression: Presented at AAGP

By Bonnie Darves

HONOLULU, HA -- March 6, 2003 -- The antipsychotic drug risperidone is effective in treating the agitation, aggression and psychosis associated with dementia, according to an analysis of recent clinical trials.

Although antipsychotics have long been used to treat the behavioural and psychological symptoms of dementia (BPSD), few systematic studies have assessed the use of these drugs in elderly patients with dementia, said the British researchers who presented their findings here March 3^rd at the Annual Meeting of the American Association for Geriatric Psychiatry.

Researchers led by Alistair Burns, MD, from Wythenshawe Hospital, in Manchester, England, performed a pooled analysis of three randomised, double-blind, placebo-controlled, 12-week trials.

All 1,150 subjects, mean age 82.3 years and 67% female, had scores of 4 or greater on the Functional Assessment Staging scale, and at least 23 on the Mini-Mental State Examination at baseline. Risperidone dosing range was between 05. and 4.0 mg/day across the three trials. A total of 722 patients received risperidone and 426 received placebo.

Treatment efficacy was assessed using the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) and the Clinical Global Impression of Change (CGI-C) and CGI severity (CGI-S).

At baseline, there was no apparent difference in either CGI-S or CGI-C scores between the placebo and risperidone-treated groups. At end point, 65.2% of risperidone-treated patients experienced marked improvement in CGI-C scores versus 45.2% in the placebo group.

Mean change in CMAI at end point was significantly greater for risperidone than placebo for total score (-11.8 versus -6.4, respectively; p<0.001) as well as for total aggression subscale score (-5.0 versus -1.8, respectively; p<0.001).

Total BEHAVE-AD scores also showed improvement in risperidone versus placebo (-6.1 and -3.6, respectively; p<0.001). The researchers said that the observed effects of risperidone occurred independent of baseline psychosis, somnolence and dementia severity or type.

Citing the need for continued studies of risperidone in the elderly population, Dr. Burns noted that the pooled analysis "provides solid evidence for the effectiveness of the drug" in treating the BPSD that afflict an estimated 60% to 90% of patients with dementia over the course of the disease.


[Study title: Risperidone In Treating Agitation And Psychosis Associated With Dementia. Abstract PO-66]

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