Objective: Falls are a significant safety concern in elderly patients with dementia. Studies indicate that 1/3 of all community-dwelling elderly, over age 65, fall at least once each year. Several studies suggest that older antipsychotics have a modest effect of increasing the risk of falls. Here we present data on the occurrence of falls from a prospective randomized, placebo-controlled study of community-dwelling subjects who participated in a comparison of olanzapine versus risperidone and placebo over a 10-week double-blind period.
Design: All patients who participated in this study (placebo n=94, risperidone n=196, olanzapine n=204) were included in analysis. The data set was searched for adverse event terms associated with falls, such as accidental injury, fall, etc. Each case record was then reviewed to determine the nature of the event, and all patients who experienced a fall were tabulated.
Materials and Methods: The mean modal doses for risperidone and olanzapine were calculated. The proportion of patients who experienced at least one fall was analyzed using Fisher’s Exact test.
Results: Olanzapine patients were significantly younger than placebo patients, but similar in age to risperidone patients (olanzapine mean age=77.9 years; placebo mean age=79.8 years, p=.042; risperidone mean age=78.0 years). The mean modal dose was 1.1 mg for risperidone patients and 5.2 mg for olanzapine patients. In this study, a total of 47 subjects experienced a fall during the 10-week double-blind phase. Falls occurred in 6/94 (6.4%) of placebo-treated patients, 18/196 (9.2%) of risperidone-treated patients, and 23/204 (11.3%) of olanzapine-treated patients. No significant difference in incidence of falls was seen across treatment groups (p=.422). Baseline MMSE scores were significantly higher for patients in the placebo group compared to patients in the olanzapine group. Placebo patients also had numerically higher baseline MMSE scores compared to risperidone patients and risperidone patients compared to olanzapine patients.
Conclusion: There are no previously published studies in the geriatric literature where a primary or secondary focus of a placebo-controlled, prospectively randomized, double-blind trial has been the occurrence of falls. The rate of falls in the placebo group, in comparison to both the risperidone and olanzapine groups, was not significantly different. Also, in light of the expected association of lesser cognitive capability with an increased risk of falls, any numerical differences present are hypothesized to be attributable to differences between treatment groups in MMSE indexed cognitive capability at baseline.
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