Objective: Falls in elderly populations are associated with injuries, loss of mobility/function, and decreased quality of life. A number of studies have implicated psychotropic drugs as risk factors for falls, but this relationship has not been systematically investigated for the atypical antipsychotic risperidone (RIS).
Materials and Methods: Data from ambulatory patients participating in a randomized, double-blind, placebo-controlled, 12-week multicenter trial of 3 risperidone dosages were evaluated. “First” falls reported as adverse events during the treatment period were analyzed using Cox regression analysis with time-dependent covariates. In another series of analyses, behavioral predictors of falls were evaluated, and following findings that wandering as assessed on the BEHAVE-AD was a significant predictor, analyses evaluated the impact of treatment on wandering, and the impact of wandering on the risk reduction for falls.
Results: Of 625 patients who participated in the trial, 537 (86%) were ambulatory (placebo n=139, RIS 0.5mg n=133, RIS 1mg n=126, RIS 2mg n=139). Of those, one hundred and nine patients (20.3%) fell during the trial. The RIS 1mg group showed statistically significant lower rate of falls than placebo (12.7% vs 22.3%; p=0.04). Fall rates for the RIS 0.5mg group (18.0%) and RIS 2mg group (27.3%) were not significantly different from placebo. Eight fractures occurred; none in patients receiving the 1mg dose. Among behavioral symptoms, only wandering was associated with an increased risk of falls. Of the 393 patients who had a wandering score > 0 at baseline, 83 (21.1%) fell. Among these patients, RIS 1mg significantly reduced the wandering score by one point (p<0.01 vs. placebo, and led to an even larger reduction in risk for falls (Hazard Ratio=0.36; p=0.01). Among 205 patients at the highest two wandering levels at baseline, RIS 1mg was associated with approximately a 70% reduction in risk for falls compared to placebo (Hazard Ratio=0.28; p<0.01).
Conclusion: Risperidone titrated to a dose of 1mg per day reduces the risk of falls in ambulatory patients with behavioral disturbances due to dementia. This effect is especially important in patients who exhibit wandering, where the magnitude of risk reduction increases with the severity of wandering. This result has important quality of life and economic implications, as falls are resource intensive and one of the leading causes of injuries and accidental death in the elderly.
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