Risperidone and falls in ambulatory nursing home residents with dementia and psychosis or agitation: secondary analysis of a double-blind, placebo-controlled trial.
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.
Katz
Ira R
IR
Section of Geriatric Psychiatry, Department of Psychiatry, University of Pennsylvania, 3535 Market St., Room 3001, Philadelphia, PA 19104, USA. katzi@mail.med.upenn.edu
Rupnow
Marcia
M
Kozma
Chris
C
Schneider
Lon
L
D000058:Accidental Falls / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015897:Comorbidity; D003704:Dementia / Q000175:diagnosis / Q000453:epidemiology*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D011595:Psychomotor Agitation / Q000453:epidemiology*; D011618:Psychotic Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D016032:Randomized Controlled Trials as Topic; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects*; D012720:Severity of Illness Index
D014150:Antipsychotic Agents; D018967:Risperidone