Safety profile assessment of risperidone and olanzapine in long-term care patients with dementia

To assess the adverse events associated with the appropriate use of oral risperidone and oral olanzapine in long-term care patients with behavioral and psychotic disturbances associated with dementia.

Observational analysis.

Analysis was performed at five consulting pharmacist sites across the United States. Participants were recruited at 89 skilled nursing facilities by consultant pharmacists who provided services at each site.

A total of 730 men and women with dementia who had been residents of a skilled nursing facility for at least 90 days were included in the study. Alzheimer's disease was the primary diagnosis in 47% of patients.

Patients were treated with risperidone < or =2 mg/day or olanzapine < or =10 mg/day for at least 90 days.

Targets for antipsychotic use included nonaggressive symptoms of psychosis and verbally and physically aggressive behaviors. The effects of risperidone and olanzapine were determined from progress notes, psychotropic monitoring forms, and physicians' order forms after 91 days of treatment. Adverse events of particular significance in the elderly population, including agitation/anxiety, laxative use, dry eyes, and falls, were collected from audited medical records. The evaluation period extended from 3 months before to 3 months after initiation of treatment with risperidone or olanzapine.

There were 474 patients in the risperidone group and 256 patients in the olanzapine group. Mean dosages of risperidone at Days 1 and 91 (0.7 +/- 0.3 mg/day and 1.0 +/- 0.5 mg/day, respectively) and olanzapine (3.3 +/- 1.4 mg/day and 4.7 +/- 2.1 mg/day, respectively) were at least 50% lower than the maximum dosages recommended by the Center for Medicare and Medicaid Services for elderly patients with psychosis or behavioral symptoms of dementia. The need for eye lubrication was minimal in both groups and did not differ significantly between them. Anxiolytic use decreased in the risperidone group and remained constant in the olanzapine group, with no significant difference between groups. In the olanzapine and risperidone groups, the number of patients with orders for laxatives increased 10.2% and 1.8%, respectively (P = 0.003), the mean number of days of laxative administration increased 19.1% and 4.3%, respectively (P < 0.001), and the mean number of doses of laxative administered increased 14.2% and 4.1%, respectively (P = 0.001). Among patients qualifying for analysis, falls were recorded for 17.9% of patients receiving olanzapine and 6.9% receiving risperidone (P = 0.001).

Among long-term care residents with dementia who received low doses of risperidone or olanzapine, the incidence of adverse events was low. When considering adverse events of particular concern in the elderly, specifically falls and laxative use, risperidone may be preferred over olanzapine in this population.