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Risperidone and Falls in Ambulatory Nursing Home Residents With Dementia and Psychosis or Agitation

Secondary Analysis of a Double-Blind, Placebo-Controlled Trial

Received November 13, 2003; revised March 30, 2004; accepted April 1, 2004. From the Dept. of Psychiatry, University of Pennsylvania, Philadelphia, PA (IRK), Janssen Medical Affairs, L.L.C., Titusville, NJ (MR), the University of South Carolina, Columbia, SC (CK), and the Department of Psychiatry, University of Southern California, Los Angeles, CA (LS). Send correspondence to Ira R. Katz, M.D., Ph.D., Section of Geriatric Psychiatry, University of Pennsylvania, 3535 Market St., Room 3001, Philadelphia, PA 19104. e-mail: katzi{at}mail.med.upenn.edu
© 2004 American Association for Geriatric Psychiatry

Objective: Authors evaluated the association between use/dosage of risperidone (RIS) and falls in a residential-care dementia population. Methods: Authors performed secondary analysis of data from ambulatory patients in a randomized, double-blind, placebo-controlled, 12-week trial of three RIS dosages (0.5 mg/day, 1 mg/day, 2 mg/day). Outcomes included number of fallers, rate of falls, and time until the first fall after randomization. Additional analyses evaluated wandering as a potential moderating or mediating variable. Results: The ambulatory sample included 537 subjects. Of those, 22.3% on placebo, 18.0% on RIS 0.5 mg/day, 12.7% on 1 mg/day, and 27.3% on 2 mg/day, respectively, fell during the trial. The difference between the RIS 1 mg/day group and placebo was significant, with a significantly lower hazard ratio in the RIS 1-mg/day group than placebo. Wandering was associated with an increased risk of falls. Among 205 patients with the highest levels of wandering at baseline, RIS 1 mg/day was associated with approximately a 70% reduction in risk for falls versus placebo condition. However, in those with the lowest levels of wandering at baseline, RIS 2 mg/day may have increased the risk of falls. Conclusions: Evaluating the benefits versus risks of risperidone in patients with dementia is complex and must consider multiple outcomes as a function of dose. At 1 mg/day, RIS was associated with decreased falls, especially in patients who exhibit wandering. However, at 2 mg/day, it may increase the risk of falls in ambulatory individuals with low levels of wandering.

Key Words: Nursing Home Care • Risperidone • Atypical Antipsychotics • Falls • Dementia • Psychosis • Agitation

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